__MAIN_TEXT__
feature-image

Page 1

ISSN  2364-2351 | A  60711 |

Life Sciences and Industry Magazine Summer Edition 2020 | Volume  19 | 20 €

Interview Pistoia Alliance data manager Ian Harrow on making life science data FAIR for the Age of AI.

COVID-19

The EU strikes back Artificial Intelligence

Antimicrobials

Focus Corona

How progress in AI and biology is transforming how we live

The pharma industry commits to launch a €1bn VC fund for AMR

Who will provide the solutions for the pandemics of the future?


Don t prepare. Just be ready. C2MAP-2000 – 1 method, 17 mins, 95 media components The C2MAP-2000 automates all steps from pretreatment to measurement without any human intervention. It simplifies the workflow for optimizing cell culture conditions. There is no need to prepare. Just be ready. Complete LCMS solution for cell culture analysis combining the C2MAP-2000 pretreatment module with ultra-fast LCMS-8060

Monitoring of up to 95 components including amino acids, metabolites, sugars, vitamins and organic acids Changes at a glance with C2MAP-TRENDS viewer software visualizing temporal changes of components

Highly efficient through cutting culture media analysis time by 80 percent

www.shimadzu.eu/c2map

C2MAP-2000 – Complete LCMS solution


European Biotechnology | Summer Edition | Vol. 19 | 2020

SARS-CoV-2 vaccines will not cure COVID-19 As the race for a SARS-CoV-2 vaccine increases, many people neglect the simple fact that, even if it is found and shown to be safe, it will not cure patients suffering from COVID-19. Once the virus has invaded the respiratory system of a patient, a vaccination is of little help. Moreover, vaccine development is often a very long process, and the production needs to supply doses for several billion people worldwide. Realistically, it will take many years, and it will cost billions of dollars. Until we have vaccinated the world and eradicated the virus, hundreds of thousands of people will likely die from COVID-19. That is why we need antiviral drugs in addition to vaccines. And, we need them quickly to treat severe COVID-19 cases and save lives today. The development of novel drugs can take more than ten years from research to market. On short notice, the pharma industry tried to repurpose existing drugs, but many of them showed no significant benefits so far, with some even worsening the patient’s condition. Some recent trials demonstrated moderate progress in ameliorating inflammation symptoms in later stages, or interfering with the virus replication to improve the prognosis for patients, but none have yet the ability to stop the virus from infecting host cells. The high financial risk of new drug development and the uncertainty of the COVID-19 “market” led many players to postpone decisions. However, there is another hope in the battle against COVID-19. When our immune system responds to the infection, it generates a valuable resource for an antiviral drug – our own antibodies that neutralise the virus. Serum from convalescent donors achieved some positive effects, but this is a quite limited and undefined resource. The better alternative would be a recombinant, fully human, virus-neutralising antibody. This type of molecule could even reach the clinics much quicker than other drug types. Fully human antibodies are typically safe and well-tolerated. Moreover, development pathways for antibody drugs are well established, and, significantly, a vast large-scale antibody manufacturing infrastructure is available. Unlike vaccines, neutralising antibodies act immediately without delay and are hoped to cure COVID-19 in later stages, as well. Due to the long halftime, antibodies can be even used as a “passive vaccine”, to protect risk groups and health care workers for a few weeks.

Picture: Verena Meier Fotografie

Dr Thomas Schirrmann is the CEO of YUMAB GmbH and Corat Therapeutics GmbH in Braun­schweig, Germany. He is a biochemist by training and completed his PhD in immunology. He worked as a scientist and research group leader for 20 years and published more than 70 scientific articles in the fields of immunology, immunotherapy, and antibody technologies. In 2012/13, he founded YUMAB, which is dedicated to antibody drug development. In May 2020, YUMAB spun out Corat Therapeutics to bring a fast-track COVID-19 antibody program to clinical trials.

So, what is the challenge? Normally, with the neutralising antibody candidate in hand, one needs two to three years to start the first clinical trials in humans. Luckily, due to the pandemics’ pressure, it seems that all institutions are doing their best to significantly shorten this process. Thanks to a concerted effort, some antibody development programmes are already on their way, and they have been conceived and approved to take only a few months. For the benefit of the patients that will still populate our intensive care units for years to come, it is important to keep these programmes up and running and financially-supported, even if the first vaccine studies appear promising. L

Intro

3


Contents

European Biotechnology | Summer Edition | Vol. 19 | 2020

Cover Story

16

COVID-19 therapies: The EU strikes back More than six months after a novel coronavirus in China first hit headlines, we’re staggering under the scope of the pandemic. How much energy and how many resources should we be pumping into vaccines, mass diagnostic testing or new therapeutics? Europe is making plans to bring production of some medicines back from Asia. Just one step in a strategy that could prove perfect or pointless, in a world that is continuing to batten down the hatches. We look at some of the many measures that could make a difference.

Insight Europe

Regional News

6 European Greens fight over ‘new genetic engineering’ – and a revision of the EU’s GMO law

64 Northern Europe: Sweden, Denmark, Norway and Finland

8

Research project investigates traceability and market control of unintended spread from genomeedited agricultural products; Big Pharma flexes its muscles.

66 Southern Europe: Italy, Spain and Greece 68 Central Europe: Germany, Switzerland and Austria

9

European Commission pledges an additional €4.9bn to fight COVID-19

70 Western Europe: France, Belgium, The Netherlands and the UK

10

Antimicrobial resistance is back on the global agenda: Industry launches €1bn Venture Capital fund

72 Eastern Europe: Poland, Czech Republic and Estonia

14 Industrial Biotechnology – achieving a sustainable green recovery

Economy 34

Interview: Federico Pollano, Senior Vice President of Global Business Development, Rentschler Biopharma SE

36 IP Flash

Science & Technology 58 Interview: AI in cancer Hartmut Juhl, CEO, Indivumed Group 62 Vital expertise in oncolytic virus production 82 Researchers begin clinical testing on a universal vaccine to rejuvenate immune systems in the elderly

Service

37 Market commentary 38 Euro Biotech Stocks 41 Update on clinical trials 44 EMA News

49 Biopeople 77 News from the SBA 78 New Products 80 Events 81 Company index 82 Encore

IMPRINT European Biotechnology (ISSN 2364-2351) is published quarterly by: BIOCOM AG, Lützowstr. 33–36, D-10785 Berlin, Germany, Tel.: +49-30-264921-0, Fax: +49-30-264921-11, Email: service@european-biotechnology.com, Internet: www.european-biotechnology.com; Publisher: Andreas Mietzsch; Editorial Team: Thomas Gabrielczyk (Editor in Chief), Derrick Williams (Co-editor), Sandra Wirsching, Uta Mommert; Advertising: Oliver Schnell, +49-30-2649-2145, Christian Böhm, +49-30-2649-2149, Andreas Macht, +49-30-2649-2154; Distribution: Lukas Bannert, +4930-2649-2148; Graphic Design: Michaela Reblin; Production editor: Benjamin Röbig; Printed at: Königsdruck, Berlin; European Biotechnology Life Sciences & Industry Magazine is only regularly available through subscription at BIOCOM AG. Annual subscription BIOCOM CARD Europe: €80 for private individuals (students €40) incl. VAT, €120 plus VAT for corporates. Prices includes postage & packaging. Ordered subscriptions can be cancelled within two weeks directly at BIOCOM AG. The subscription is initially valid for one year. Subscriptions will be renewed automatically for one more year, respectively, unless they are cancelled at least six weeks before the date of expiry. Failures of delivery, which BIOCOM AG is not responsible for, do not entitle the subscriber to delivery or reimbursement of pre-paid fees. Seat of court is Berlin, Germany. As regards contents: individually named articles are published within the sole responsibility of their respective authors. All material published is protected by copyright. No article or part thereof may be reproduced in any way or processed, copied and proliferated by electronic means without the prior written consent of the publisher. Cover Photo: sdecoret/stock.adobe.com; ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

Picture: sdecoret/stock.adobe.com

4


Contents

European Biotechnology | Summer Edition | Vol. 19 | 2020

ARTIFICIAL INTELLIGENCE

Data Management

Editorial

Positive perception

Medicine – a new age Self-learning algorithms are growing common not only in oncology, and a flood of new publications suggests they already outperform trained experts in many areas of diagnosis. Pharma giants have cracked open the door to machines choosing drug candidates. AI is set to have a huge impact in the coming years on both health systems and patients.

60

Collecting FAIR data

Pictures: NIAID(below), pinkeyes/stock.adobe.com (upper left), Pistoia Alliance (middle), BIOCOM AG (right)

50

A survey conducted by the Pistoia Alliance found that AI in the life sciences is still being held back by data issues and skills shortages. We spoke with Ian Harrow, a Consultant at the Alliance, about how to improve data management in the field with help from a new toolkit that makes data Findable, Accessible, Inter­operable and Reusable – in brief: FAIR.

FOCUS COVID-19 23 24 26 28 29 30 32

Targeting coronaviruses A rapid test for pandemics Interview: Raimund Gabriel, CEO and Founder, MC Services Munich, Germany The end of partnering events as we know them Antiviral drugs for pandemic preparedness Sourcing reference products Defining the bioprocess early is key to quality control

Will the COVID-19 crisis prove to be a turning point for the acceptance of biotech in Europe? Until recently, a majority of EU citizens only had negative associations with biotechnology – GMOs are a case in point (see p. 6). The novel coronavirus, however, is changing this mass perception dramatically (see p. 26). With the world desperate to put lockdowns behind as quickly as possible, biotech fields are the only ones to offer hope through possible solutions – whether in diagnostics, therapies or vaccines (see COVID-19 Special pp. 16–35). And when biotech is no longer viewed as a threat, its platform technologies will bear economic fruit more quickly, and much more of it. At least, that's according to a new McKinsey study entitled "The Bio Revolution" (see p. 50). It predicts biotech could have €10 trillion in growth potential by 2040 – but only if it gains wider acceptance. Only then will sustainable methods in areas such as agriculture, AI-supported diagnostics and enzyme synthesis prevail, the study says. With biotech’s help, will politicians be able to seize this opportunity to make Europe the most sustainable place on the planet? Or will governments prioritise preserving vested interests – a choice that will be paid for by our children’s children? We’ll only know when the pandemic has passed. But until then, there's plenty we can personally do to keep the vision alive.

Thomas Gabrielczyk Editor-in-Chief

5


Insight Europe

European Biotechnology | Summer Edition | Vol. 19 | 2020

European Greens fight over a revision of EU GMO law new Breeding methods  An impulse paper of a green splinter group has ignited a storm in the

water glass. Like industry and science lobbyists, the renegades are calling for changes to the EU’s legal GMO framework.

EU Health Commissioner Stella Kyriakides has ordered a study on new genomic techniques that is foreseen for spring 2021.

Martin Häusling, the Greens/EFA agricultural policy spokesman at the European Parliament, has made it clear that an impulse paper published in June by 22 party members is nothing more than a contribution to the discussion. In a paper entitled “New times, new answers: regulating genetic engineering law in keeping with the times”, party members had called for the so-called “new genetic engineering” to be scientifically evaluated and newly regulated at EU level. In the paper, important German Green politicians had advocated the controlled use of the CRISPR gene scissors and so-called new breeding methods in agriculture. Instead of blocking modern genetic breed-

ing methods, they want to discuss about possible applications and help shape policy to use the technology responsibly and in line with green objectives where it can help to solve global problems. When he took office, Robert Habeck, party chairman of the German Greens, had also said that before the adoption of the new basic programme this year, the fundamental rejection of agricultural genetic engineering must also be discussed.

No change at all With fast-track position papers of the Parliamentary Group and the Greens in the European Parliament on the subject, the

discussion seems to be over for the time being, according to Häusling, spokesperson for agricultural policy of the Greens/ EFA in the European Parliament and Harald Ebner, spokesperson for genetic engineering and bio-economic policy in the German Parliament. “The paper voted on today reaffirms the clear position of the Greens/EFA group from across Europe on the need to take the precautionary principle to heart and fully implement the 2018 ECJ ruling,” Häusling said. “Deregulation of procedures and thus the elimination of risk assessment, monitoring, labelling and traceability is out of the question for us,” he made clear. Attempts to use genetic engineering to alleviate the symptoms of disease in intensive agriculture, such as the much-cited drought resistance of plants, “are doomed to fail”, he said. Relying on genetic engineering methods would lead to an even greater concentration of the seed market on a few players and would fall into the hands of large corporations.

Differentiated approach It remains to be seen whether the discussion initiated by the impulse paper is over before it has even taken place. In the paper, the 22 signatories question the previous rejection of principles represented by Häusling and Ebner and want a differentiated approach to genetic engineering methods. “Since the current pace of innovation is no longer sufficient to save the climate and the environment”, but also to contain pandemics such as “COVID-19”, it was necessary “to find science-based evaluation criteria

Pictures: European Parliament/OLIVIER HOSLET

6


Insight Europe

News Pharma flexes muscles  The European Federation of Pharmaceutical Industry Associations (EFPIA) has criticised the recently presented Roadmap to the EU’s Pharmaceutical strategy. Over the past twenty years, the EU’s R&D base has gradually eroded, with new cutting-edge technology research units being transferred out of Europe, mainly to the US and more recently to China, said Nathalie Moll, Director General of EFPIA. EFPIA said it would help to reverse the negative trend reflected by the fact that 47% of new treatments originate from the US compared with just 25% from Europe (2014-2018).

Traceable or not?   As it is not yet possible to differentiate how a point mutation arose – naturally or technically by genome editing or classical mutagenesis – Germany has set up a research project to investigate how traceability and market control of unintended traces of genome-edited agricultural products can be ensured. According to the current state of knowledge, the precise identification of genome-modified plants depends on prior information on genome modification and availability of reference material. Under the research project, different analytical detection methods for mutations will be evaluated such as RNase Hdependent PCR, digital droplet PCR (ddPCR), TaqMan PCR, and NextGeneration Sequencing (NGS). NGS testing will be designed based on the comparison of sequence data between the genome-edited plant and the parental line. An appropriate detection limit has been set to at least 20 copies of the target sequence.

European Biotechnology | Summer Edition | Vol. 19 | 2020

for the use of new technologies,” the paper states. It was also important “to promote their sustainable use” and to limit only profit-oriented applications that damage the environment and climate. At times, the tenor of the paper actually sounds as if it comes from science or industry lobbyists: new breeding methods like CRISPR-Cas9, when properly used and regulated, offer a great opportunity for sustainable agriculture, the authors argue adding. “In order to counteract the “monopolisation of agriculture by large companies” that would be supported by the current EU GMO legislation, plant breeding oriented towards the common good and sustainability should be “promoted in public research institutions and in SMEs”. This would include release experiments with breeds of the new genetic engineering. “There is no such thing as good or bad genetic engineering – we, as a society, should discuss and define areas of application on the basis of risks and opportunities,” the paper states.

Spring 2020 edition) is being prepared that will shed light on the advantages of biotechnological mutagenesis methods and serve as the basis for a political reorganisation of the legal framework for these breeding methods. A position paper of the German Christian Democrats, which is correspondingly close to industry and science, underpins their ideas of sustainable agriculture. Accordingly, the German Minister of Agriculture, Julia Klöckner (CDU) praised the contribution of the Greens to the discussion: “I welcome the rethinking in the ranks of the Greens to open up to scientific findings in the new breeding technologies. Because conflicts of objectives are not solved by merely describing them, but by finding ways to solve them and allowing them to be solved”. Industry and science lobbyists had recently emphasised that the Green Deal goals set for 2050 would be difficult to achieve with current breeding methods, namely:

›› The reduction of chemical pesticides

EC’s deregulation plans

by 50%;

›› 20% less fertilizer and 50% less nitroThe paper is explosive because, under the Christian Democratic Commission President Ursula von der Leyen, an expert report (see European Biotechnology,

Martin Häusling wants to further promote an ecologically-friendly and benficial agriculture more strongly.

gen and phosphorus;

›› an unspecified reduction in the emission of greenhouse gases, especially from animal husbandry; ›› 25% of agricultural land should be farmed organically. Even the Commission, which has long been reticent on the subject of genetic engineering, drops all barriers in its farmto-fork strategy: “Innovative techniques, including biotechnology” can play a role in “increasing sustainability”. However, the “sustainable intensification” associated with this, also called for by the Intergovernmental Panel on Climate Change (IPCC), does not seem compatible with the ecological circular economy promoted by the Greens since 1980. The direction in which the desired change in the European legal framework for new breeding methods in agriculture will take – and whether or not the Greens will contribute to it – can be eagerly awaited. L t.gabrielczyk@biocom.eu

Oicxture: Martin Häusling

8


Insight Europe

European Biotechnology | Summer Edition | Vol. 19 | 2020

EU Commission pledges €4.9bn against COVID-19

Pictures: European Commission Audiovisual Service/Etienne Ansotte

EC President Ursula von der Leyen CoronaVIRUS GLOBAL RESPONSE 

At the beginning of May, the European Commission (EC) had already announced the funding of €4bn for the COVID-19 vaccine research, €2bn for the development of therapeutics and €1.5bn for the development of diagnostic test kits within the Coronavirus Global Response Framework. The initiative proposed by the G20 – which aims to build sufficient capacity as quickly

as possible to supply everyone with COVID-19 vaccines, treatments and tests at affordable prices – mobilised €6.15bn in additional funding at the end of June through the ‘Global Goal: Unite for our Future’ pledging summit.

Access for everyone The European Investment Bank (EIB) and EC provided €4.9bn while the EU mem-

ber states committed €485m to ensure equitable access to coronavirus vaccines, tests and treatments. This brings a total pledge under the EU initiative to €15.9bn; €11.9bn thereof given by the Member States, the EC and the EIB, the rest committed by other governments, the Bill and Melinda Gates Foundation, the Coalition for Epidemic Preparedness (CEPI), the Global Alliance for Vaccines and Immunization (GAVI) and the World Bank. The joint agenda aims at avoidig national or fragmented efforts that could pose a risk for the most vulnerable economies across the world. The summit resulted in commitments for the production capacity of over 250 million vaccine doses for middle and lower income countries. However, Germany, the Netherlands, France and Italy had already previously secured 300 million vaccine doses of the adenoviral vector vaccine AZ1222 developed by AstraZeneca for €750m, and the USA had even secured 1 billion vaccine doses through BARDA funding. The vaccine was licenced from the University of Oxford. “The world will only be freed from this pandemic when vaccines, tests and treatments are available and affordable to everyone who needs them,” said EC President Ursula von der Leyen. L t.gabrielczyk@biocom.eu

Bioprofile FLEX2 with On-Line Autosampler

Fully Automated Sampling, Analysis, and Feedback Control of Bioreactor Cultures Fully automated sampling and analysis for up to 10 bioreactors Small 5.6 mL bioreactor sample volume for the full test menu including gases, electrolytes, metabolytes, osmolality and cell density/cell viability Sample throughput as fast as 6 minutes For more information, register for our free web seminar: FLEX2 On-Line Autosampler: Fully Automated Sampling and Analysis Nova Biomedical Schweiz GmbH | Herostrasse 7 | 8048 Zürich | Tel: +41 41 521 66 55 | E-Mail: ch-info@novabio.com Nova Biomedical GmbH | Hessenring 13 A, Geb. G | 64546 Mörfelden-Walldorf | Tel: +49 6105 4505-0 | E-Mail: de-info@novabio.com

9


Insight Europe

European Biotechnology | Summer Edition | Vol. 19 | 2020

Antimicrobial resistance is back on the global agenda AMR  In the run-up of this year’s virtual AMR Conference 2020 (24 – 28 August), the European

interest group BEAM Alliance has asked his members to evaluate the impact of COVID-19 on their businesses. According to first results, a majority is dealing with R&D programme delays and financing difficulties. Meanwhile, big pharma companies have prepared a new global initiative to be launched mid-July that aims for a significant financing push: a new fund will be started.

Will SMEs involved in the development of novel antimicrobials survive the current COVID-19 crisis? The answer to this question is probably “maybe”. According to first results of a survey that was conducted among BEAM Alliance member companies in May, at least 46% had more difficulties than ever to raise public or private money for their AMR R&D programmes and another 43% saw at least delays in those activities. At the same time, a large part of the companies is optimistic, prompting that the COVID-19 crisis will have a slightly positive impact on the financing environment within the next 12 to 18 months and some of them even said that the crisis is offering new opportunities outside their regular AMR-related business.

Strong push for recognition of infectious disease expertise Now, in cooperation with AMR conference organiser BIOCOM AG, the survey has been enlarged to include additional stakeholders in the field of antimicro­bial resistance (AMR) to receive a broader picture on the impact of the Covid-19 crisis. “These times have provided a strong push for recognition of infectious diseases expertise and some of our companies are actively involved in the fight against COVID-19,” says Marc Gitzinger, CEO of Swiss company Bioversys and BEAM Alliance Board member. “We are more than ever calling for incentives that help antibiotic developers to overcome current market fail-

On 9th July a broad coalition of pharma assocations, pharma CEOs, policy makers and AMR experts launched a new global intiative to fight antbiotic resistance in a virtual event series in Berlin, Washington and Tokyo.

ures.” Now, there seems to be significant progress in the field. In mid-July, the big pharma associations IFPMA, PhRMA and EFPIA together with German association vfa and US-based BIO have jointly launched a new global venture fund to support companies involved in midstage development of novel antimicrobials. Based on preparations made by the World Health Organization (WHO) and the European Investment Bank (EIB) – with additional support of the Welcome Trust –,a new fund will be set up to finance later stage clinical development. “Around $1bn will be earmarked in a first step,” announced a coalition of pharma CEOs from MSD, Pfizer, Eli Lilly, Roche, GSK, Novartis, Boeh­ringer Ingelheim,

Merck KGaA, Bayer and Novo Holdings on a virtual launch event that took place in Berlin, Washington and Tokyo on 9th July. For the sector this is unprecedented news: Never in the past such a large and high-level pharma industry panel ever highlighted the need to bring money on the table when it comes to antimicrobial development. In addition, further renowned experts in the field such as Kathy Talkington, Pew Charitable Trusts, Helen Boucher from Tufts Medical Center or Kevin Outterson, Executive Director and Principal Investigator, CARB-X on the US part of the event, as well as Dame Sally Davies, UK Special Envoy on Antimicrobial Resistance and Jeremy Farrar, Director, Wellcome Trust,

Picture: Screenshot/BIOCOM

10


PASSION FOR PERFORMANCE

YOUR�WORLD-CLASS BIOPHARMACEUTICAL�CDMO •���Experts�in�cell�culture�bioprocess�development� and�manufacturing •���Family-owned�company,�globally�thinking�and� focusing�exclusively�on�our�clients‘�projects •���Biopharma� pioneer� with� commitment� to advanced�technology�and�innovation�leadership� •����Extensive�track�record,�40�years�of�experience� and�quality�made�in�Germany

YOUR�TRUSTED�PARTNER FROM�CONCEPT�TO�MARKET

INCREASED PRODUCT�VALUE •� Tailored�algorithm-based and� database-driven formulation�development •� Superior� stability� and� quality

Rentschler Biopharma SE Erwin-Rentschler-Str.�21�·�88471�Laupheim�·�Germany info@rentschler-biopharma.com�·�www.rentschler-biopharma.com


12

Insight Europe

European Biotechnology | Summer Edition | Vol. 19 | 2020

Is the COVID-19 crisis affecting your business-as-usual AMR activities? 46.2% Yes, a lot  

48.7% Yes, a bit  

5.1%

No

Is the COVID-19 crisis offering you new opportunities outside your regular business (i.e., AMR)? 23.1%

64.1%

Yes, I expect a 6-month delay or more  

12.8% Yes, I expect a delay up to 6 month  

No, I do not foresee significant delays

Is it more difficult to raise money (public & private) for your AMR programmes at the moment? 46.2% Yes, more than ever  

43.6% Not necessarily more difficult but delayed  

10.3% I see no impact

* A total of 39 companies provided answers to the survey

Source: BEAM Alliance Covid Survey, May 2020.

In May, BEAM Alliance conducted a member survey on the impact of COVID-19.

joined this virtual launch event to acknowledge the global effort in the fight against antibiotic resistance. Further highlevel policy representatives such as German health minister Jens Spahn, WHO director Tedros Adhanom Ghebreyesus and Stella Kyriakides, European Commissioner for Health and Food Safety, and US Senators Robert P Casey (D-PA) and Bill Cassidy, MD (R-LA) accompanied the event as well. “We have long waited for such a broad and international support for companies active in developing antibiotics and such an impressive line-up of CEOs and policymakers urging the need to fight against antibiotic resistance,” said Florence Séjourné, CEO of French company Da­Volterra and president of BEAM Alliance. “We are welcoming this incredible effort and hoping that it will soon bear fruit. It is time for action.” According to BEAM Alliance, significant push incentives can be a first step to address the precarious situation many SMEs in the field are facing, particularly those companies being in costly late development stages. However, the organisation is also highlighting that pull incentives are critical to safeguarding post-approval and market conditions that allow for antibiotic developers and investors to regain at least some of the financial efforts they made in the past to develop novel antibiotics. “If we are not addressing the pull incentive side, many of the push efforts could soon be marginalised,” Gitzinger told

European Biotechnology. Based on this consideration, during this year’s AMR Conference which will happen fully digitally with high-level panels and expert sessions from 24 to 28 August, BEAM Alliance will present a new action plan to highlight the next steps that are crucial for SMEs active in the fight against AMR. “We are particularly calling for action in Europe. Efforts here need to be more coordinated and efficiently pursued so that European stakeholders are in the position to play a leading role,” BEAM representatives say. The Alliance welcomed the fact that European policy stakeholders from the Parliament such as Tiemo Wölken, MEP S&D German, vice-chair of European Parliament MEP Interest Group on AMR, have been part of the launch event on 9th July as well.

UK pull incentive seeks candidates for novel antibiotics Meanwhile, the UK government’s activities of NHS England and its Antibiotic Procurement Pilot has also kicked off. Until the 22nd of July, interested companies with relevant drug candidates in the market can now apply to make a tender offer. As a summary, the goal of the project is to select two drugs: one that received marketing authorisation in the UK between January 2017 and December 2019 and one that will receive a new marketing authorisation between January and December 2020. Both products will

then undergo a health technology assessment (HTA) by NICE throughout 2021 using adapted methods for antimicrobials. The HTA will be used to estimate the value of each of the antibiotics. Once selected, the NHS England proposes to pay a subscription fee of up to £10m/year for a decade for each of the two new antibiotics covering WHO priority pathogens, whether the antibiotic is used or not. According to international AMR expert John Rex, ”the analysis suggests that they are proposing – if the rest of the G20 pays its fair share – a global pull incentive of up to $4bn.” If and when additional pull incentive activities will be started in other countries remains unclear so far. In the US, there are currently two types of legislation being considered by the Congress. The DISARM Act would increase Medicare reimbursement to hospitals for the use of antibiotics against antimicrobialresistant pathogens. The PASTEUR Act would also initiate in the US a de-linked subscription model, in which the government would pay a fee to ensure access to specified antibiotics in the event of need. “Both bills would help ensure that, if and when the nation needs antibiotics against a new superbug, these antibiotics will be available,” said Cornelius (Neil) J. Clancy, MD, associate professor of medicine and director of the extensively drug-resistant pathogen lab and mycology programme at the University of Pittsburgh. L  s.wirsching@biocom.de


I advance

because, at this company, innovation isn’t limited to research – it’s everywhere.

Join us to grow, collaborate, innovate and improve lives. Apply at: careers.boehringer-ingelheim.com


Insight Europe

European Biotechnology | Summer | Vol. 19 | 2020

How to reach a sustainable green recovery? Post-Covid Economy  With a letter to the EU Commissioners signed by more than 60 industry

leaders, the Bio-based Industry Consortium (BIC) called for a stronger recognition of the bio-based sector in the recovery discussion. Supporting a sustainable green recovery in line with the European Green Deal will be also in the focus of Germany’s Presidency of the Council of EU. Meanwhile, several companies from different industries publicly re-inforced their sustainability efforts.

In June, French Carbios SAS published details of a highly effective enzymatic depolymerisation process for the bulk plastic product PET that allows a truly circular PET production with only 5% waste.

With a letter to the EU Commissioners signed by 63 industry leaders, the Biobased Industry Consortium (BIC) calls for a stronger recognition of the bio-based sector in the discussion around green recovery. “With about €700bn turnover and 3.6 million people employed, the bio-based industries are helping to alleviate the impact of the crisis by keeping essential services running and maintaining green jobs,” they say and underline that “Our companies are providing much-needed supplies such as food and feed ingredients, (compostable) packaging, hand sanitizers, masks, tissues and energy from renewable feedstock.” Also,

they argue that “the bio-based sector can help by turning the crisis into new opportunities for green growth and by being a strong partner in the EU’s green economic recovery.” Back in April, The European Bioeconomy Alliance (EUBA) urged in a position paper that the bioeconomy has a pivotal role to play in the transition to a more circular, sustainable and resource-efficient society.

EU Green Deal implementation “Supporting a sustainable green recovery in line with the European Green Deal will be in the focus of Germany’s Presi-

dency of the Council of EU,” said Andrea Noske, Head of Bioeconomy Division at the German Federal Ministry of Research during a webinar, organised by EuropaBio end of June. “Of course, the German EU Council presidency has to pursue a smart balance between COVID-19 related issues and other midand long-term issues,” she said. And “strengthening excellence in innovation towards a sustainable Europe will remain high priority on the agenda“. Implementing the Green Deal will mean in this regard, that for instance, an “initiative on Green Hydrogen” as well as a “Plastic Pirates” initiative will be started, Noske said in the webinar. How Europe will be positioned in a post-covid-19 economic scenario, will be further discussed during this year’s EFIB conference, EuropaBio’s annual gathering of high-level experts in the bio-based economy. For this year the organisers will provide a fully digital edition, taking place from 5 to 9 October.

BASF issued first green bond Meanwhile, the industry committed to sustainability efforts. End of May, BASF announced it had established a framework for financing instruments based on sustainability criteria. This green finance framework enables BASF to finance sustainable products or projects offering a clear benefit to the environment and society with green bonds on the capital market. The company successfully placed bonds with a total volume of €2bn on the capital market. With the second

Picture: Carbios SA

14


Insight Europe

European Biotechnology | Summer | Vol. 19 | 2020

tranche, BASF issued its first green bond. “This now firmly anchors sustainability in BASF’s financing strategy as well,” said Hans-Ulrich Engel, Chief Financial Officer. During the webinar of EuropaBio, BASF representative Cordula Mock-Knoblauch, Director Renewables & Sustainability, Global New Business Development Operating Division Intermediates from BASF stressed that bio-based solutions as a driver for low-carbon-footprint products are among the priority activities of the company. She highlighted how bio-based products are currently integrated in the BASF value chains. ”This includes diversification of the raw material base”, she said.

Picture: Sergej Khackimullin / Fotolia

Alternative raw materials Another industry stakeholder, chemical company Covestro, also highlighted its sustainability efforts during the webinar. Irene Latorre Martinez, Senior Project Manager in the Business Unit Coatings, Adhesives and Specialties from Covestro Latorre Martinez introduced four main areas that help raising a resource-efficient circular economy: alternative raw materials, innovative recycling, joint solutions, and renewable energy. “The circular economy is a driving force for Covestro – both within the company and its value chains as well as in products and consumer sustainability,” she said. A key point is the importance of cooperation and collaboration in this transition. As an example she provided the new partnership between Neste and Covestro. Renewable diesel producer Neste has entered this strategic cooperation to promote the use of sustainable raw materials in plastics production. Covestro will be supplied with material from renewable sources to replace a significant portion of the fossil raw materials used to date in the manufacture of polycarbonates. This type of a high-performance plastic is used, for example, in car headlamps, LED lights, electronic and medical devices and automotive glazing. Over the short term, the collaboration aims to replace several thousand tons of fossil raw materials

in the production of polycarbonates with raw materials produced with Neste’s renewable hydrocarbons.

Potential of bio-waste A lot of untapped potential to valorise bio-waste (garden and food waste) in Europe is depicted in a new joint report of BIC and Zero Waste Europe (ZWE). The document details the current generation and capture rates of bio-waste for each EU-27 Member State, plus Norway and the United Kingdom. According to the report, the current capture of food waste is only 9,520,091 tonnes per year, just 16% of the theoretical potential, estimated at 59,938,718 tonnes. The report and country factsheets provide examples of how the bio-based industries contribute to tackling this waste challenge as well as citing best practices in waste management at the municipal level. The experts underline that bio-waste can serve as a valuable feedstock for the bio-based industries and the sector is well-placed to convert bio-waste into high-value bio-based products. They argue that this innovation can alleviate Europe’s food waste challenge and stimulate new opportunities for sustainable growth contributing to Europe’s green recovery. “The bio-based sector is already valorising bio-waste in smart and efficient processes with zero-waste objectives. Several projects funded by the Bio-based Industries Joint Undertaking (BBI JU) demonstrate how innovation in our sector can convert bio-waste into high-value biobased products. The bio-based industries seek to achieve a resource-efficient and zero-waste society as identified in our Vi-

sion. The planned EU public-partnership – Circular bio-based Europe – will help further realise this,“ says BIC Executive Director Dirk Carrez. ”The report shows that biowaste management remains an untapped potential for the European Union to further transition to a Circular Economy. Only 16% of the potential is currently captured and, through proper initiatives, this number could be multiplied by 5 so as to reach 85%,” comments Pierre Condamine, Waste Policy Officer at Zero Waste Europe emphasising the need for the EU and Members States to maintain and strengthen their effort in biowaste collection and treatment as key steps towards soil regeneration, circularity and climate neutrality.

Amazon and sustainability That novel technologies will play a key role also for other big industries, was recently underlined by another global player. In June, IT company Amazon committed to investing in the development of sustainable technologies and started the Climate Pledge Fund, with $2bn in funding. “It will invest in innovators who are building products and services to help companies reduce their carbon impact and operate more sustainably,” said Jeff Bezos, Amazon founder and CEO. “Companies from around the world of all sizes and stages will be considered, from pre-product startups to well-established enterprises. Each prospective investment will be judged on its potential to accelerate the path to zero carbon and help protect the planet for future generations.” L  s.wirsching@biocom.de

15


AI

Digitally colored scanning electron micrograph of apoptotic cells (burgundy) heavily infected with SARS-CoV-2 virus particles (green), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland (US).

European Biotechnology | Summer Edition | Vol. 19 | 2020

Pictures: xxx

16


COVID-19

European Biotechnology | Summer Edition | Vol. 19 | 2020

COVID-19 therapy – the EU strikes back Corona Crisis  No one can yet predict with any certainty what strategies will prove most effective

against COVID-19. Along with upping production capacities for vaccines and diagnostics, European Union leaders are discussing plans to expand production of the first effective therapeutics. Under the German EU presidency, some production could be brought back from Asia.

F

or Andrea Ammon, Director of the European Centre for Disease Control (ECDC), the decline in the number of infections with the new SARS-CoV-2 coronavirus in most European countries is only a stage, not a victory. “I don’t want to draw a doomsday picture, but I think we have to be realistic. The virus seems to be very well adapted to humans. Now is not the time to completely relax,” she said – just before a second wave of infection hit Israel.

how long development could take. Then there’s the question of how long it will protect recipients. At a virtual expert briefing of the German biotech industry association BIO Deutsch­land, she suggested establishing a monitoring system by September that includes making diagnostics available in every doctor’s practice in the country, in

Pictures: NIAID, NIH (left), ECDC (right)

Three-pronged strategy Experts like former FDA head Scott Gottlieb are predicting that a second wave could descend on Europe and the US this autumn, roughly two years before the European Medicines Agency (EMA) estimates a protective vaccine will be available for the broader population. While heavily funded vaccine coalitions have advanced the clinical development of potential jabs, and are busy ramping up capacities for potential mass production (see p. 18), there are a lot of open questions. For example, it’s unclear whether any of the current vaccine candidates in clinical testing will be able to prevent virus entry where it’s needed – at the mucous membranes in the upper respiratory tract. According to HIV pioneer and Aicuris GmbH founder Helga Rübsamen-Schaeff “there’s no guarantee” that there will even be a COVID-19 vaccine, and no real idea

Dr. Peter Llewellyn-Davis  CEO, Apeiron Biologics AG, Vienna, Austria

? !

 hy is APN01 more specific for W the treatment of Covid-19 than other therapies?

APN01 is specific to treat Covid­19. It’s not a repurposed drug. SARS and Sars-cov-2 use the same receptor to enter cells. An imitator of the ACE2 molecule, APN01 binds specifically to the virus, inhibits infection, and protects the lung.”

order to to quickly identify infected people who have to be quarantined. She also recommended making therapies available that demonstrably alleviate the course of the two disease phases of COVID-19 – viremia and host immune response. “Realistically, vaccine development will take many years, and will cost billions of dollars,” says Thomas Schirr­ mann. The CEO of antibody developer Yumab and CORAT Therapeutics GmbH told European Biotechnology that “until we have vaccinated the world and eradicated the virus, hundreds of thousands of people will likely die from COVID-19. That’s why we need antiviral drugs in addition to vaccines.” Results from the UK’s Recovery trial demonstrate that approved drugs like dexa­ methasone could provide a quick lifeline. The cheap anti-rheumatic cortico­steroid (US$15/10-day course of treatment) saved the life of one in eight ventilated COVID-19 patients compared to the standard-of-care. On the other hand, the antiviral HIV treatment lopinavir-ritonavir and malaria medicine hydroxy­chloroquine failed. The first clinical results from IL-6 blockers like SanofiRegeneron’s saralimumab or Roche’s tocilizumab – which might help control late-stage cytokine storms – showed mixed results.

EU boosts manufacturing Impressed by the success of dexamethasone, the German EU presidency is mak-

17


18

COVID-19

European Biotechnology | Summer Edition | Vol. 19 | 2020

Selection of SARS-CoV-2 vaccine candidates currently in clinical testing (RBD=receptor-binding domain; FL=full length S protein; CEPI= Coalition for Epidemic Preparedness Innovations)

Vaccine

Company/ Licenser

Stage (as of 07/20)

CDMO partner

Stated production capacity (doses) annually

Description

› CoronaVac

Sinovac Biotech

Phase II/III

in-house, new facility being built

100m

Immunogenic inactivated SARS-CoV-2 live vaccine

› Inactivated SARS-CoV-2 Vaccine

Chinese Academy of Medical Sciences

Phase III/III

n.a.

n.a.

Inactivated SARS-CoV-2 Vaccine

› Ad5-nCoV

Beijing Institute of Biotechnology/CanSino Biologics Inc

Phase III

n.a.

70–80m/year in-house, expansion plans not published

Replication-deficient, adenovirus-based vector type 5 vaccine

› AZ1222 (ChAdOx1 nCov-19)

AstraZeneca/ Univ. of Oxford/ Insitut Pasteur

Phase II with 1,000 healthy volunteers

US: Emergent Biosolutions EU: Catalent

US: 0.4bn/2020; 1.2bn/2021 EU 0.4bn/2020 1bn/2021

Recombinant replication-deficient chimpanzee adenoviral vector vaccine vs FL

› Gam-COVID-Vac Lyo

Gameleya Research Institute (RUSS

Phase I

n.a.

n.a.

Adenoviral prime boost vaccine against FL (prime: adenovirus type 26, boost: adenovirus type 5)

› mRNA-1273

Moderna, Inc

Phase II

Lonza Ltd. Visp, CH/ Portmouth US

Globally 1 bn/year

mRNA-1273 encodes FL. Phase II study established an in-vitro virus-neutralising dose of 50µg. Phase III trials expected for July have been postponed due to a change in study design

› BNT162 program

BioNtech SE Fosun Pharma Co Ltd; Pfizer Inc

Phase I/II

Polymun for clinical lots, in-house scale-up

Unspecified “hundreds of millions” doses/2020

best of 4 modfied mRNA candidates targeting FL or RBD will be selected for Phase III studies

› nCoV-2019 vaccine

CureVac AG

Phase I/II

Tesla Grohmann

Dependent on final dose (2-8 µg), “gram-scale within weeks”

CEPI-funded nCoV-2019 vaccine that can be produced decentrally using a still unapproved RNA printer co-developed with Tesla Grohmann

› LNP-nCoVsaRNA

Imperial College London

Phase I

n.a.

n.a.

Self-amplifying RNA vaccine

› INO-4800

Inovio Pharmaceuticals

Phase I/II

RichterHelm/Oligy

1m by 2020

CEPI-funded DNA vaccine candidate

› NVX‑CoV2373 + Matrix-MTM adjuvant

Novavax Inc

Phase I/II

n.a.

US: 100m doses by 02/2021

Virus-like particle (VLP) SARS-CoV-2 vaccine

ing plans to bring some production capacities for COVID-19 therapeutics back to Europe. After a briefing with the four bio­p harma industry associations BPI, ProGenerika, BAH and BIO Deutschland, the German government launched informal talks in the EU Council in midJuly on how to ensure that a certain percentage of repurposed COVID-19 drugs can in future be produced independently of Asian suppliers in places like China or India. Following confidential talks, the CEO of German pharmaceutical industry association BPI Kai Joachimsen stated: “The corona crisis shows us what shaky feet our healthcare system stands on. It is

of central importance to reduce dependencies, minimise supply bottlenecks and secure supplies in the long term.”

“Researchers and companies know they need to collaborate to find COVID-19 countermeasures, but in the background there’s huge competition for funding.” A previous survey across members of the four associations showed that EU production would cost significantly more than it

does in lower-cost countries. China produced roughly 32.5 tons of dexamethasone in Q4/2019 – sufficient for half a million treatment courses – while Indian API producer Wockhardt announced in June that the company could rapidly ramp up annual production of dexamethasone to 150 tons.

Panic buying as a reaction … As market approval for innovative treatments (see pp. 23, 29) will take longer than repurposing old drugs, it’s still not clear whether the EU Presidency’s plan will also cover EU-based innovations with high potential for value creation, among


YouR molecule OuR priority

Product Characterization Reveal your biologic’s attributes earlier and faster with expert guidance

Learn more about our off-the-shelf assay packages at MerckMillipore.com/your-pc-partner

© 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved. Merck, the vibrant M and BioReliance are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. 30821 07/2020

The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.


20

COVID-19

European Biotechnology | Summer Edition | Vol. 19 | 2020

them areas like passive immunisation, or developing drugs that specifically target corona­viruses. Germany’s generics manufacturing initiative is a reaction to a kind of COVID-19 medical-supply nationalism. Initiated by Donald Trump, ‘Operation Warp Speed’ in the US is supposed to deliver safe and effective coronavirus vaccines to Americans by the end of the year.

… to nationalist sourcing After Trump paid US$1.2bn to secure an ‘exclusive’ supply of AstraZeneca’s COVID­-19 jab AZ1222, an EU alliance of Germany, Italy, France and the Netherlands subsequently secured 400 million doses of the vaccine candidate for €935m. At the same time, the European Commission, the European Investment Bank (EIB) and EU Member States, as well as international partners, have pledged €15.9bn under the newly launched Coronavirus Global Response Framework to support access for low-income countries to future COVID-19 vaccines, therapeutics and diag­nostics. At the launch of the initiative in May, EC President Ursula von der Leyen concluded: “The world will only be freed from this pandemic when vaccines, tests and treatments are available and affordable for everyone who needs them.” In addition to vaccines and therapeutics, COVID-19 diagnostics are emerging as an increasingly important pillar for the management of the corona crisis. Progress in Mechanisms

automation and point-of-care (POC) diagnostics could soon speed up mass testing, allowing social restrictions to ease.

Rapid testing to the rescue? However, according to WHO recommendations, the current rate of false-positive and false-negative results still appears only acceptable for PCR tests. The organisation has so far refused to recommend the use of two viral antigen-based diagnostic tests from Quiddel and Becton Dickinson that received FDA emergency approval in May and July. The WHO says that although such tests can theoretically identify current SARS-CoV-2 infections within 15 minutes, they’re still not sensitive enough. The same is true for COVID­-19 antibody tests, which the agency recommends for “research-only” use, but not for diagnostic purposes. In mid-May, Juliet Bryant from the Fondation Mérieux in Lyon (France) and colleagues published evidence that COVID antibody tests, which detect the spike- and nucleocapsid antigens of SARS-CoV-2, inadequately assess individual immunity to the novel coronavirus. Published in the peer-reviewed journal Science Immunology (doi: 10.1126/sciimmunol.abc6347), the study was bad news for policymakers looking to relax social distancing measures with the help of ‘immunity passports’. The researchers did say, however, that such tests could provide valuable information Sample collection

Biomarkers

Immune response

Blood

At the beginning of July, US researchers launched a real-world diagnostics data accelerator that will link diagnostic test results to patient data and outcomes in order to provide real-life sensitivity and specificity data on PCR and antibody tests. Big clinical labs like those at Quest Diagnostics Inc., Roche and Lab­C orp have joined the accelerator to improve COVID-19 diagnostics. Fully-automated PCR point-of-care tests running on the Vivalytics platform made by Bosch Healthcare Solutions GmbH and Randox Ltd are an option for ‘rapid’ testing in settings like airports. Because the respiratory panel test only needs 2.5 hours from swab Diagnostic methods Central lab and Point-of-care

Hybrid methods (MDx+LAFs)

Central lab and Point-of-care

DNA sequencing (MDx)

Central lab

Viral antigen

Antigenic test (LFAs)

Point-of-care

Specific antibodies

Serological test (LFAs)

Point-of-care

Sputum nasopharyngeal swab or alveolar lavage fluid

COVID-19 diagnostics

Progress on the testing front

qRT-PCR and Isothermal amplification (MDx)

Viral nucleic acid

Virus detection

when it comes to addressing critical public health questions like when to relax stay-athome orders, or school closures. Swiss researchers had previously reported that SARS-CoV-2 RNA levels in wastewater can identify emerging local COVID-19 hotspots. The underlying technology is currently being commercialised by UK companies Integumen Ltd and Aptamer Group Ltd. A third emerging diagnostic pillar is tracking cyto­kine production, which doctors could use to predict if a life-threatening immune response in ventilated COVID-19 patients will occur. In June, Roche’s Electys IL-6 assay received FDA emergency authorisation for this kind of patient stratification.

Source: IDTechEx Research

Rapid point-of-care and laboratory tests promise to help authorities make choices on when to ease social isolation measures.


Fast molecular tests, anywhere

 "

†|ol-|;7Â†Ń´ŕŚžrŃ´;Š $;vাm]"‹v|;l Concept

Development

Launch

NEO

Ultrafast Batch $;vাm]"‹v|;l Concept

Development

Launch

NANO Disposable $;vাm]"‹v|;l Concept

Development

Launch

Learn more at gna.bio


CoVID-19

European Biotechnology | Summer Edition | Vol. 19 | 2020

onstrated people infected with G614 had significantly increased case fatality rate. Furthermore, the mutation didn’t seem to impair the effects of antiviral serum therapy or vaccine candidates. This shows that the claim that only a vaccine could help to end the COVID 19 pandemic is scientifically at least questionable.

A glimmer of hope

Bosch Healthcare and Randox Ltd’s automatic COVID-19 POC PCR test can also be conducted by non-specialists.

to result, passengers who need to test negative to fly can do it directly at the airport. German company Centogene, which announced a collaboration with Lufthansa and Fraport GmbH, which manages Germany’s largest airport, are working to speed up Frankfurt’s current mobile PCR testing speed from four to two hours. Some next-generation hybrid tests still under development (see p. 24) are aiming to combine speed with high sensitivity and specificity.

Fierce competition For governments, it’s often difficult to distinguish PR from scientifically reliable information because competition for funding is so fierce in research labs and industry. At the end of May, sequencing experts Hans Lehrach and George Church came up with a concept they claim would “eliminate the spread of the coronavirus in a short time, at a comparatively low cost, and return us to our pre-pandemic lives.” According to Lehrach, it requires sequencing capacities equal to the challenge of testing an entire population in one go, and people would first have to return to quarantine for five weeks. Every week, they would provide a saliva sample, which would be prepared and subsequently checked for parts of the SARSCoV-2 genome in a regional analysis center using next-gen sequencing technology. Anyone affected would be quarantined until they are no longer contagious.

That’s just one idea. There are other examples proposing state contracts with diagnostics companies that provide highthroughput SARS-CoV-2 antibody testing to identify who’s been infected and who hasn’t. Another widely ignored factor in the joint race against COVID-19 of developers and policymakers is the role of the viral evolution speed for the duration of the protective effect of a vaccine. While a highly cited study on the mutation rate of SARS-CoV2 – which investigated a single superspreader and the people infected by him – suggested a low mutation rate of the novel coronavirus SARS-CoV-2, a more recent, peer-reviewed one has come to completely different conclusions.

Viral evolution In July, researchers at the Sheffield COVID-19 Genomics Group reported in Cell (doi: 10.1016/j.cell.2020.06.043 ) that the virus has adapted to humans very quickly, thus calling into question whether vaccination against SARS-CoV-2 can provide lasting protection. They identified a variant that carries a mutation in the viral Spike (S-)protein called G614 that has continued to spread during the lockdown due to its high contagiousness. It became the dominant form in Europe and the US (currently 78% of cases) within three months. The good news is that the researchers couldn’t confirm previous data (doi: 10.1111/ijcp.13525) that dem-

There are also interesting new concepts outside the mainstream. In late June, the FDA greenlighted a clinical Phase I/II trial for a vaccine that doesn’t focus that much on inducing neutralising antibodies, but instead on boosting the TH1 cell response to viral attacks in elderly patients. According to Michael Har-Noy, CEO of Jerusalem-based Immunovative Therapies Ltd, Allo­Stim® could provide “protection from any future viral infection, including progression of the current outbreak of COVID­-19 infection, and any future variants of SARS-CoV-2 or the next Disease X.” Allo-priming uses allogeneic, intentionally mismatched, ex-vivo differentiated and expanded living TH1-like cells. Preclinically, multiple intra­dermal injections of Allo­ Stim® have created a dominant titre of allo-specific TH1/CD8-T-cytotoxic memory cells in circulation, replacing the dominance of exhausted memory cells in an aged immune system. Upon viral encounter, says the company, bystander activation of the allo-specific memory cells causes an immediate release of interferon g, stopping viral transcription and leading to bystander activation of innate cellular effector cells and activation of cross-reactive allo-specific CD8-T-cytotoxic lymphocytes. However, recent research shows that T cell titres also play an important role in controlling viral reproduction. Har-Noy sees his approach as a fallback option if other vaccines fail. “If allo-priming is proven to work as designed, a single series of shots could protect against the current pandemic, as well as any future pandemic,“ he believes. Clinical testing in the US will begin by the end of July. Har-Noy is still seeking a partners in Europe and Southeast Asia. L t.gabrielczyk@biocom.eu

Picture: Bosch Healthcare

22


Advertorial

European Biotechnology | Summer Edition | Vol. 19 | 2020

Targeting coronaviruses COVID-19  Viennese APEIRON Biologics AG raised €17.5m to expand ongoing Phase II trials of its  

coronavirus-specific drug candidate APN01 in Europe to the US and Russia. The recombinant angiotensin-converting enzyme 2 (rhACE2) mimics the receptor on the human cells that coronaviruses are using to infect these cell. Preclinical and clinical data demonstrate that APN01 is well-tolerated and can stop the overshooting host immune responses that are triggered by virus proliferation.

Pictures: Apeiron Biologics AG

APN01 (rhACE2) is one of the most advanced drug candidates for the treatment of COVID-19 and one of the few therapy approaches specifically directed against the coronavirus. Originally, the recombinant human Angio­tensin Converting Enzyme 2 (rhACE2) was designed by Apeiron to target SARSCoV-1 during the first SARS epidemia. When SARS-CoV-1 disappeared APN01 was clinically developed for the treatment of acute lung injury (ALI), acute respiratory distress syndrome (ARDS), and pulmonar y ar terial hyper tension. ALI/ARDS is the major source of  Covid-19 mortalities. S A R S and S A R S - CoV-2 use the human ACE2 receptor, which is expressed in human airway epithelia as well as lung parenchyma, to enter human cells. Soluble APN01 binds specifically to the viral Spike (S-) protein and inhibits infection and protects the lung (see figure). The double-blind, randomised, placebo-controlled study aims to treat 200 patients with severe COVID-19 disease to further data characterise the impact of rhACE2 on biological, physiologic, and clinical outcomes, as well as safety in patients with severe SARS-CoV-2 infection. If the current Phase II study is positive, regulatory agencies may grant accelerated market approval.

Advancing the clinical pipeline At the beginning of June, APEIRON Biologics AG completed a financing round totalling €17.5m. As part of

Dual mode of action: APN01 blocks virus entry and the ARDS-associated inflammation.

a rights issue with a private placement, the company was able to raise €11.9m from existing and new private and institutional investors, including the  Vienna Insurance Group, which contributed approximately €7m, resulting in a participation of 3.26% in APEIRON Biologics. In addition, the Austrian Research Agency (FFG), the Vienna Business Agency (WAW), the Austria Economic Service Company (AWS), and Erste Bank have earmarked public funding and guarantees totalling €5.6m. The assets will be used to advance the development of APN01 and the further development of immuno-oncology projects.

“With the completion of these capital measures the financing of our clinical COVID-19 development and our immuno-oncological cell therapy projects is secured and the whole team at APEIRON is highly commited to drive both programs forward to bring new treatment options to patients in need,” said Peter Llewellyn-Davies, CEO of APEIRON. Contact

Apeiron Biologics AG Dr. Peter Llewellyn-Davies CEO investors@apeiron-biologics.com www.apeiron-biologics.com

23


COVID-19

European Biotechnology | Summer Edition | Vol. 19 | 2020

Rapid test for pandemics Diagnostics  Rapid tests have received a lot of attention during the Coronavirus pandemic,

but as the number of tests available has increased, so has the confusion around the different types and what they can deliver. What if there were laboratory quality tests that could produce a result in just a few minutes?. › Anastasia Liapis, PhD, VP Strategic Marketing & Partnerships, GNA Biosolutions GmbH, Munich

Rapid tests have the potential to facilitate broader screening and have been discussed in many countries as a tool to lift coronavirus restrictions, however testing capacities as well as the variability of the tests themselves have limited their implementation. The most common, safest method for diagnosing COVD-19 infection is PCR (Polymerase Chain Reaction). In PCR, the genetic material of the virus is detected in the laboratory to assess viral infection. Typically, PCR test results are available after several hours, but it often takes much longer for the patient to receive their result depending on infrastructure. This is because it takes time for a sample to make its way to the laboratory where the evaluation is made by expert laboratory personnel. Once that evaluation is available, results then need to go back to the test site, and finally to the patient. During this pandemic, PCR-based rap-

id tests have become available, but with some limitations: they are typically the most expensive option, which limits their suitability for screening. Furthermore, the definition of “rapid” when it comes to PCR tests can vary wildly, from 15 minutes (e.g. ID Now) to several hours (e.g. Vivalytic).

Immune response vs viraemia The vast majority of rapid tests to become available in the recent months have been antibody tests. These tests detect a person’s antibody immune response to the SarsCoV-2 virus rather than the virus itself. Therefore, these tests are not suitable for detecting acute infection with Sars-CoV-2 virus. Furthermore, it remains unclear whether the antibodies produced as a response to SarsCoV-2 infection are protective for future infection – and if so, for how long. Finally, there are antigen-based rapid tests, which directly detect components

PCA can detect Sars-CoV-2 within 15 minutes.

of the Sars-CoV-2 virus itself in approximately 20 minutes. These tests, while less expensive and faster than PCR, have been limited in how sensitively they can detect infection. Relative to PCR, current antigen-based tests are about a thousand times less sensitive. This means that while they may be faster, less expensive, and easier to implement, they have a much higher potential to produce large numbers of false-negative results, missing many active infections.

Hybrid PCA tests New technologies that can deliver the best of PCR tests (high sensitivity) as well as antigen-based tests (speed and ease of use) have been lacking. One new technology that can deliver across these parameters is Pulse Controlled Amplification (PCA), a next-generation PCR technology developed by GNA Biosolutions in Germany. PCA technology functions similarly to PCR at the chemical level, utilising conventional polymerases and primers, with the needed sensitivity, but with tests that take minutes rather than hours (Figure 1). Portable, energy efficient and even disposable PCA-based systems are currently in development for Sars-CoV-2 testing and promise to deliver new powerful solutions for combatting Covid-19 and other infectious disease threats. With this new generation of molecular diagnostic systems as well as better integration of test reporting and result tracking, a safe test for coronavirus that can be purchased in a pharmacy, or even performed at home, is becoming a possibility within reach. L

Picture: GNA Biosolutions GmbH

24


PEPperPRINT GmbH ‡ +49 6221 7264489 ‡ pepperprint.com ‡

pepperprint-gmbh

pepperchip

PEPperPRINTgmbh

PEPperPRINT


Interview

European Biotechnology | Summer Edition | Vol. 19 | 2020

The new role of communications in times of corona Corporate Communication  COVID-19 has put life science research companies into the

limelight. European Biotechnology spoke with Raimund Gabriel, founder and managing director of MC Services AG, on the role of corporate communications in the corona crisis.

many journalists worldwide,which was exceptional and a great opportunity to speak about biotech innovation in Europe. But many companies still find it difficult to identify and address their local and national political decision makers, influencers and supporters.

EuroBiotech_How has the corona crisis changed the biotech sector in terms of communications? Gabriel_It is the first time that mass media

have pursued broader European biotech stories so aggressively. In the past 20 years, public awareness of EU biotech was rather slim and often associated with controversial topics such as GMOs. Now, biotechnology is seen as a main source of hope in the current worldwide health crisis. This has presented a unique opportunity to demonstrate the contribution of the biotech industry to public health. But it’s also a challenge. Companies can easily be overwhelmed by the recent level of public interest. Also, scientists from biotech and academia are now faced with generalist audiences. It is a time of enormous potential and challenges for communicators. E u r o B i o t e c h _ M a ny d e ve lo p er s of COVID-19 vaccines, therapies or diagnostics made it into the mass media. How can small research companies standout in the midst of an increasing COVID-19 competition? Gabriel_At the beginning of the pandemic,

small companies with innovative clinical approaches had a good chance of attracting attention despite being previously unnoticed by the media. Also U.S. investment banks called to learn about relevant corona research projects in Europe. As the number of clinical trials increased however, media attention became increasingly competitive and eventually a certain pandemic fatigue in the editorial offices began to set in. It is now more important to differentiate both in science and communications.

EuroBiotech_What advice do you have for developers who are not involved in COVID-19? Gabriel_ Stay focused in your communi-

Raimund Gabriel is the founder of MC Services, a leading European life science communications and investor relations firm. Earlier he held senior management positions in international financial and corporate communications agencies.

EuroBiotech_How has the Corona crisis changed communications with politicians? Gabriel_Looking back, there was little di-

rect dialogue between political decision makers and the biotech industry, except through biotech associations. However, this is changing. Now, government leaders are talking to biotech CEOs directly and the first results are emerging. In Austria, there was public funding for Apeiron, in France for Abivax and in Germany for CureVac. The latter raised interest from so

cations on your core business. The increase of general interest in biotechnology may offer life science companies new platforms to position products and science. Concomitantly, language and tools of biotech communications will need to change to be appreciated by general audiences. This will require new strategies and creative formats. EuroBiotech_Do you expect the German Council Presidency to provide further momentum for biotechnology? Gabriel_Preparation for pandemic risks is

now on the European agenda. The German presidency can certainly inspire and support this process. COVID-19 revealed a pressing need for, diagnostics, ventilators, rescue medications and vaccines. The same is true for other viral threats, infectious diseases and novel antibiotics. Still though, the question hangs: Who pays for the development of medicines that are not frequently used but developed for future emergencies? It is very important that EU institutions are increasingly stepping into financings of public health issues such as the EIB who took a leading role in the funding of COVID-19 projects. L

Picture: MC Services AG

26


Economy

European Biotechnology | Summer Edition | Vol. 19 | 2020

The end of partnering events as we know them pharma partnering  An ongoing crisis and evolving new working habits of industry exec-

utives call for an entirely new and up-to-date partnering format. Workarounds such as moving a partnering event’s scheduled one-on-one meetings online is neither imaginative nor does it meet the requirements of flexibility and effectiveness. The format presented here sounds the bell for a new era of pharma partnering. › Dr Norbert Rau, Founder and New Projects Advisor, RauCon GmbH & Co. KG

one, single tool in their RauCon User Accounts. They are able to fix any number of prearranged follow-up or stand-alone video meetings running in RauCon’s secure cloud environment. They can also turn already fixed halfhour event meetings into full-hour video meetings and move them to any date within the four-week period if circumstances require.

Transforming Pharma Partnering

Dr Norbert Rau redesigned the 25-year-old euroPLX partnering concept

Even without mentioning the currently most ubiquitous word, we know why partnering events hit rock bottom lately. Sitting face to face across a table is not exactly what you mean by physical distance. This being said, it seems obvious that partnering events need a new metaphor just like the one that RauCon introduced 25 years ago on 20 June 1995 with the euroPLX concept: just business deals, no lectures, no company presentations, no keynotes, no stunts or similar distractions was tantamount to a new event category, a world’s first.

The Advent of a New Category Seventy-odd successful euroPLX events later, RauCon now launches the next new

category of pharma partnering: the Marketplace for Pharma Business Opportunities. Why? “Because our customers asked: Why should pharma partnering be confined to a few event days while business development is a year-round challenge?” says Dr Norbert Rau, the designer of euroPLX. “We listened and decided to expand the two-days events to four-weeks marketplaces and to add value and a degree of flexibility for our customers, which is unheard of in the partnering world.” The idea of tomorrow’s pharma partnering as a marketplace for business opportunities is ripening apace. Registrants for euroPLX and asiaPLX now create and control their own flexible Video Meetings Programme through

The new era of partnering will combine physical encounters and virtual meetings in the most flexible way possible. Merely replacing the participants’ physical presence at a conference by video links is bound to fail, due to technical and organisational glitches. It causes inconveniences for the participant and adds no value. While personal encounters will remain essential, executives are getting used to home office work, video conferencing, travel restrictions, and distancing. Business development partnering calls for imaginative and intelligent solutions, not for workarounds. Executives call for a next generation event format, a corona-proof partnering concept that suits their new working habits. They need it right now to support their business activities. The new euroPLX and asiaPLX Marketplaces are what they are looking for: www.raucon.com. L

Picture: RauCon GmbH & Co. KG

28


Advertorial

European Biotechnology | Summer Edition | Vol. 19 | 2020

Antiviral drugs for pandemic preparedness COVID-19  Viral pandemics are not a once-in-a-lifetime event but a constant threat looming over our

heads. While the fight against SARS-CoV-2 is currently a top priority, we should not lose sight of what might come next. Broad-spectrum antiviral drugs like Atriva’s ATR-002, currently in Phase II clinical development for treating COVID-19, could be an effective measure in the fight against the current pandemic and future viral outbreaks.

Picture: Atriva Therapeutics GmbH

What was first – the virus or the cell? To date, this question remains unanswered. What is clear is that viruses – parasitic genetic material packaged in a shell or an envelope – have been hijacking human cells ever since mankind came into existence. Unable to reproduce on their own, viruses take advantage of our sophisticated cellular machinery to make thousands of copies of themselves, killing our cells in the process. Our history together has been a troubled one: while many viruses are simply a nuisance, giving us a runny nose or a light fever, others cause severely disabling symptoms and even death. Every once in a while, a new virus capable of infecting large numbers of people emerges, causing worldwide pandemics. This is not a recent phenomenon: The last century alone saw three major worldwide influenza outbreaks (1918, 1957 – 58, 1968) and the start of the HIV pandemic. So far, in the twenty-first century, there has been an influenza pandemic in 2009 and the current SARS-CoV-2 outbreak. And it does not stop there. Recent reports identify a new type of swine flu with pandemic potential.

Pandemic preparedness We need to be prepared to fight these pandemics, so we do not have to suffer losses and halt our economies eve-

ry few years because of a novel viral threat. While it is extremely important to develop treatments and vaccines for the current SARS-CoV-2 outbreak, we also need to think about the future, as pandemics are here to stay. Once a new virus shows up, effective antivirals are needed to address it. The current toolbox against viruses contains some options; however, many are limited to a few specific viruses, have a small therapeutic window, and are susceptible to viral evasion. New approaches are

needed to equip ourselves for future viral threats. Since 2015, Atriva has been working to develop novel antiviral therapies that function against a wide range of respiratory infections, with an initial focus on influenza. The company’s lead drug candidate is the MEK inhibitor ATR-002, an oral small molecule with a dual benefit directed against both viral replication and excessive host immune responses. Unlike other approaches, ATR-002 does not target the virus directly, but inhibits a host cellular pathway that is essential for the replication of a number of RNA viruses. This host-targeting approach makes the development of viral drug resistance far less likely and can combat any virus that relies on Raf/MEK/ERK signalling. Besides influenza virus and SARS-CoV-2, many other life-threatening respiratory RNA viruses take advantage of this pathway, including RSV and Hantavirus, which is associated with bio-  weapon potential. ATR-002 is currently in clinical development for the treatment of COVID-19 (Phase II, ongoing) and influenza (Phase II planned for winter 2020/2021). If successful, it could become a unique broad-spectrum antiviral and the instrumental answer to viral pandemics and seasonal epidemic threats, such as influenza. Contact

Atriva Therapeutics GmbH info@atriva-therapeutics.com www.atriva-therapeutics.com

29


COVID-19

European Biotechnology | Summer Edition | Vol. 19 | 2020

Sourcing reference products Biosimilar Development and Manufacturing  A biosimilar is a copy version of an

approved, original biological medicine whose patent protection has expired. The development strategies for biosimilar product and a new biological entity (NBE) differ in many ways. › Andreas Nechansky, Site Manager, ABF Pharmaceutical Services (Member of GBA Group Pharma)

For biosimilar products, the mode of action is the same as of the marketed product, thus minimizing the risk of failing in clinical trials. However, the regulatory expectations regarding the product quality and the biosimilarity assessment prior to entering into the clinical stage makes the development of a biosimilar product more difficult (and more expensive in the preclinical phase) compared to an NBE. Strict guidelines from the EMA and the FDA have been published that raise the bar very high for companies that develop biosimilars. Because most process information for the innovator is not available to the public, establishing biosimilarity to innovator (also called the reference product) is challenging. Initially, a detailed analysis of innovator lots is required, in order to obtain information about the reference product (RP); then, an extensive physicochemical and biological characterisation needs to be performed, as so to demonstrate the analytical biosimilarity between the biosimilar and the RP. The implementation of an RP sourcing program at this very early stage of development is mandatory. Challenges are mainly related to identifying suppliers that have access to innovator lots from various regions (US, EU, and China) and getting enough lots at the right time. Additionally, the Certificate of Analysis (CoA) for the RP lots is informative, in order to understand what quality attributes have been tested, and can also help to set initial release specifications for the proposed biosimilar product.

RP-Testing: from young to old lots The reference product sourcing strategy should be coupled with a storage

Dr andreas nechansky has worked for more than 25 years in the biopharmaceutical industry in leading positions and has also founded his own company.

and stability testing strategy. The goal of RP sourcing is to cover the RP life cycle and – when starting the development program – to have RP lots available for testing that represent “young,” “mid-aged,” and “old lots” (= end of shelf life, EoS). Taking Mabthera, as an example, the shelf life is two years, thus, ideally to understand any changes of product quality over these two years, lots aged below three months (“young”), around one year (“mid-aged”), and close to two years (“old”) should be included in testing. It is not recommended to source many lots of RP from a short period of time, because they may come from the same drug substance (that can be stored frozen for many months) and, therefore, do not represent the diversity of the actual RP manufacturing process. In that case, the only variabil-

ity that is revealed by testing such batches is related to the analytical method. This is an additional argument for sourcing more innovator lots, which requires implementing a strategic sourcing plan before starting the development. Old RP lots are used to understand product changes manifesting at the end of shelf life – for example, the charge pattern might change and also the monomer peak might decrease. It should be noted that the procurement of RP lots that fullfill the criteria discussed above is difficult, because there are only a certain number of lots per year available in the market.

Testing in Humans For clinical testing, the RP batch has to be selected very diligently, because it serves as the indicator for biosimilarity (a margin of 80 – 125% is allowed, where the bio­ similar has to fall within for read-outs like PK or PD). From a sourcing perspective, it is important to source a large enough amount and to begin early enough in time to start the trial.

About ABF / GBA Group Pharma ABF, a member of GBA Group Pharma, has an extensive global network and long lasting experience in sourcing RP for Biosimilar development. As a logistics service provider, we have supported the export of such material into non-EU countries located in Asia, the Middle East, and the US. GBA Group Pharma is one of the largest and most experienced service providers in the European pharmaceutical and biotechnology sector. L  www.gba-pharma.com

Picture: GBA Group Pharma

30


in life sciences communications

CORPORATE COMMUNICATIONS Strategy Editorial Work Media Relations Media Events Media Trainings Issues & Crisis Management Corporate Websites

INVESTOR RELATIONS IR Consulting Financial PR Financial Reporting IR Outsourcing IR Events IR Websites Investor Presentations

WWW.MC-SERVICES.EU

PRODUCT & SCIENCE PR KOL Engagement Medical Writing Media Planning Marketing & Sales Support Life Cycle Management Reimbursement Rx, OTC, Generics, Biosimilars, Medtech

ROADSHOWS & TRANSACTIONS* IPOs Secondaries & PIPEs Private Financings Investor Targeting Roadshows & Organized Field Trips Special Investor Group Meetings Feedback Reports

* Tied Agent for Investment Brokering according to Sec. 2 (10) KWG CapSolutions GmbH


COVID-19

European Biotechnology | Summer Edition | Vol. 19 | 2020

Defining the bioprocess is early quality control Biomanufacturing  As the process determines the product, product characteristics of

biological drugs need to be analysed thoroughly right from the beginning of the drug development process. Early understanding of structure-function relationships, aggregation, microheterogenicity, and glycosylation, and more, helps minimise development risks. › Daniel Galbraith, PhD, Director of New Services and Technology Management, Merck

Developers of small molecule pharmaceuticals perform a battery of analytical tests before early clinical trials. These tests fulfil the regulatory requirements of the pharmacopoeia and are done in a standardised method. With small molecule drugs, the testing of the final product is relied upon. In today’s complex world of biologics, however, success demands a completely different approach, as the process and the product define the drug and a more orthogonal approach to analytics is required.

What makes biologics different? The intricacies of biological manufacturing, the large size and complex structure

of the molecules, as well as the final product microheterogeneity introduced by cellular expression systems present significant challenges to measuring the quality of a biologic drug. During the early phase of drug development, much about the drug’s quality attributes are unknown and must be established empirically by physical, structural, and functional analysis. Established testing procedures can confirm core properties, such as identity, peptide sequence, and molecular mass. However, newer, high-resolution analytical techniques can answer questions regarding product heterogeneity with respect to charge, size, glycan structure, and posttranslational modifications. Additionally, measuring the biological potency of a drug, such as a monoclonal

antibody, is difficult. This is particularly true at the very early stages of drug development, where there may be little, or no bio-analytical methods developed to specifically measure a novel biological drug’s activity. In-depth knowledge of a product’s chemistry, structure, and biological activities facilitates easier process design and helps to ensure that the drug attains critical product safety, purity, and potency parameters.

Risk mitigation strategies A key priority is understanding the relationship between the basic physicochemical profile and biological activity and how this relationship affects clinical performance, thus enabling a developer to make informed decisions that accelerate development and reduce risk throughout the product’s life cycle. Understanding how clone selection, media, the manufacturing process, and its scale-up affect critical quality parameters of monoclonal antibodies and the level of heterogeneity that can be accepted to guarantee certain product attributes is also crucial to project success. Merck has summarised the crucial steps in product characterisation of biolo gic s in a w hi t e p a p e r. O n e can download the full white paper, “Early Product Characterization Mitigates Risks in Biologics Development” from Merck’s Knowledge Centre at: merckmillipore.com/your-pc-partner.

L

Picture: Merck Life Sciences

32


COVID-19

European Biotechnology | Summer Edition | Vol. 19 | 2020

33

EU Parliament calls for European health union

Picture: European Parliament

Eu Presidency  European policy makers

seem to be determined to provide stronger support for the interests of the bio­ pharmaceutical industry. In mid-July, the European Parliament published a resolution calling for much greater cooperation between Member States on health issues. “The corona pandemic has shown that we need to work much more closely together. Just like the virus, many other health threats know no borders, which is why politicians must act more jointly,” said Dr Peter Liese, CDU, health policy spokesman for the largest group in the European Parliament (EPP/Christian Democrats). A large majority of the MEPs support the four priorities outlined by biopharmafriendly German Health Minister Jens Spahn for the German EU Presidency.

First, better cooperation is needed for combatting the pandemic. According to the Christian Democrat Spahn, Germany wants to strengthen the European Centre for Disease Control (ECDC). Second, greater cooperation in the development of vaccines and medicines and improvement of appropriate infrastructures is key.. Germany wants EU leaders to establish a EU agency that mirrors the activities of the US agency BARDA. Third, the German EU presidency aims at harmonising current telemedicine standards (e-health) to improve compatibility across borders. As Spahn is a big promotor of Big Pharma’s access to health data, this would create a pilot for big data processing through self-learning algorithms (see page 50).

Fourth, Germany wants the EU to overcome excessive dependencies on Asian API makers. First, informal talks how to bring production of essential medicines and strategically important medical products back to Europe, will start in midJuly. “We want to create a European health union,” said Liese. The MEPs also call for legislative proposals to reduce the use of antibiotics and incentives, which complement the €1bn fund announced in July (see page 10) for the development of new antibiotics Furthermore, MEPs call for an action plan on health professionals, rare diseases, and mental illness. L

-

&RPSOHWHSDFNDJHIRU&29,'GLDJQRVWLFV 6XSSRUWLQJWKHGHYHORSPHQWRIYDFFLQHVDQGWKHUDSLHV

SARS-CoV-2 assays

CE marked

EURORealTime SARS-CoV-2 6HQVLWLYH FSƑO DQGVSHFLILF  GLUHFWYLUXVGHWHFWLRQYLD3&5XVLQJWZRWDUJHWVHTXHQFHV Only one reaction per sample

Anti-SARS-CoV-2 ELISA (IgG) / Anti-SARS-CoV-2 NCP ELISA (IgG) $QWLERG\GHWHFWLRQEDVHGRQVSLNHSURWHLQGRPDLQ6RUPRGLILHGQXFOHRFDSVLGSURWHLQ 1&3  +LJKFRQILGHQFHLGHQWLILFDWLRQRIDQWLERG\SRVLWLYHDQGQHJDWLYHLQGLYLGXDOV Assessment of antibody status after administration of vaccines or antibody therapies Fully automatable

9LVLWZZZFRURQDYLUXVGLDJQRVWLFVFRP

For further information contact infection-pm@euroimmun.de EUROIMMUN AG · Seekamp 31 · 23560 Lübeck (Germany) · Tel +49 451/ 20 32-0 · Fax 20 32-100 · info@euroimmun.de · www.euroimmun.com


Interview

European Biotechnology | Summer Edition | Vol. 19 | 2020

Rentschler Biopharma expands U.S. footprint Biomanufacturing  Prior to Danish Genmab A/S’s recent licence option deal with AbbVie Inc,

Rentschler Biopharma has extended its collaboration with Genmab. European Biotechnology spoke with Rentschler Biopharma SE’s SVP Global BD Federico Pollano about the CDMO’s expertise in DuoBody® molecules production and the expansion of the CDMO’s U.S. production site in Milford.

EuroBiotech_What specific expertise does Rentschler Biopharma have in the development and production of bispecific antibodies? Pollano_ At Rentschler Biopharma, our

strength lies in our proficiency with highly complex molecules. Our track record of 100 therapeutic protein formats, for a Rentschler Biopharma’s U.S. facility in Milford, near Boston.

total of about 300 molecules, clearly reflects this expertise. We have almost 20 years of experience in the production of multispecific antibodies, including bispecific and trispecific antibodies. These account for close to one quarter of our development and production portfolio. This is no small feat, and we pride ourselves on the know-how and capabilities that we have developed for a range of formats, in bioprocess development and cGMP manufacturing, for our 150 clients worldwide. Federico PolLano, is Senior Vice President of Global Business Development at Rentschler Biopharma, located in Laupheim, Germany. He has over 30 years of experience in pharmaceuticals and biopharmaceuticals, mainly in senior and executive positions at the following companies: Polpharma Biologics, Richter-Helm BioTec, Helm, BioGeneriX, Glaxo Wellcome, and Zambon. Pollano studied biology at Bielefeld University in Germany, and at the German Primate Centre, in Göttingen, Germany.

its-kind collaboration that will involve several novel projects and enable the client to decide in a flexible and agile way, which projects to advance and when. Hence, our clients benefit from the freedom to transfer a broad portfolio of products to Rentschler Biopharma and then flexibly determine the course of their project based on clinical readouts and management decisions.

EuroBiotech_How will Rentschler Bio­

EuroBiotech_What are the technical challenges in the production process of DuoBody® molecules ? Pollano_The production of bispecific an-

pharma support the clinical supply for client projects, as in the case of DuoBody® molecules for Genmab? Pollano_Rentschler Biopharma offers an innovative, client-oriented business model that allows for the flexible allocation of resources in the clinical supply for our clients. The same model forms the basis of our strategic collaboration with Genmab, for the process development and manufacturing of bispecific antibodies generated with Genmab’s DuoBody® technology platform. This partnership represents a first-of-

tibodies, like DuoBody® molecules, means combining two drugs to create one. When generating antibodies, problems posed by protein expression, stability issues or application of non-standard approaches can often lead to disappointing results. During processing or antibody purification, optimal yield strongly depends on precisely controlled reactions for complete heterodimer formation of the bispecific antibody. At the same time, unwanted reaction components must be efficiently eliminated whilst analytically monitoring and carefully characterizing

Pictures: Rentschler Biopharma

34


GBA Group Pharma Services linkedin.com/company/gba-group-pharma twitter.com/GBAGroupPharma gba-pharma.com

GBA GROUP PHARMA SUPPORTS DAILY MORE THAN 300 CLINICAL STUDIES

Preclinical Services

GMP Testing

Central Laboratory

Clinical Trial Supply

Commercials

Regulatory Affairs


Economy

the reaction steps. The implementation of additional process steps within a fixed time window further increases the challenge with regards to the production of monoclonal antibodies.

European Biotechnology | Summer Edition | Vol. 19 | 2020

IP Flash

EuroBiotech_What role does the new contract have within the U.S. expansion strategy of Rentschler Biopharma? Pollano_ Our strategic collaboration with

Genmab fits well with the expansion plans for our U.S. site in Milford, MA. The site is already taking on new projects, including complex and difficult-to-manufacture proteins. In total, Rentschler Biopharma intends to continuously invest in site expansions to develop the site into a centre for excellence, offering multiple technologies and capabilities for numerous products. We also continue to hire additional people at the site, to keep pace with the site development and business growth. Expanding our global footprint and client centricity has been the key driver here. EuroBiotech_What is the time schedule for the expansion of your Milford site, which was acquired last year? Pollano_The first step in expanding

Rentschler Biopharma’s site in North America is a 500 L single-use bioreactor, which is operational now. The next step includes constructing another building for large-scale single-use manufacturing. We plan to leverage our expertise for client projects through every phase, be it early-stage development or clinical and commercial production. This will be achieved through site development and the hiring of additional people, as previously mentioned. EuroBiotech_Does Rentschler Biopharma plan to produce there at an industrial scale? Pollano_Yes, the expansion of our Mil-

ford site translates to a significant increase in our production capacity. Keeping current production, our project pipeline, and future expansion plans in mind, we can produce on clinical as well as commercial scales. L t.gabrielczyk@biocom.eu

By Dr Laura Haas, Boehmert & Boehmert, Munich, Germany SPCs  SPCs offer up to five and a half

tagliptin was developed after the priyears of additional protection after pat- ority/filing date of the basic patent. It ent expiration for pharmaceuticals in or- satisfies the functional definitions in der to compensate the patent holder’s the claims, but was not specifically inability to exploit their inventions while disclosed. products undergo lengthy regulatory apIn response to the questions that the provals. Nevertheless, the messy, diverg- Bundespatentgericht referred to the ing national case law over one require- CJEU, the court ruled, that generally, ment for obtaining an SPC as set out in it would be possible to grant an SPC, the EU Regulation even if the product No. 469/2009, would not be spenamely that the cifically disclosed And now for something product has to be in the basic patent. completely different – “protected” by However, a skilled protection in case of SPCs the base patent p e r so n must b e for pharmaceuticals? (“Article 3(a)-reable to deduce diquirement”), has r e c t ly a nd u n e caused a decadequivocally that the long debate over several flashy legal product falls within the scope of proconcepts like “technical contribution,” tection. For this, a two-step test was “inventive contribution,” and “core in- established (see CJEU’s 2018 decision ventive advance”. Teva vs Gilead), in which patentability In “Royalty Pharma” (C-650/17), the requirements (disclosure requirements, Court of Justice of the EU (CJEU) now novelty and inventive step) were adagain attempted to bring some clarity mixed into the scope of protection to this matter in an appeal by Royalty analysis. Pharma against the refusal of an SPC By doing so, the CJEU created nothapplication at the DPMA (German Pat- ing less than a specific set of rules for ent Office), due to a failure to comply patent protection in case of SPCs. Most with the Article 3(a) requirement. interestingly, an infringement defense Royalty Pharma applied for an SPC can now be created based on a later in Germany, based on a basic patent obtained patent that is the result of an that claims the use of a functionally “independent inventive step” over a defined class of inhibitors for the treat- basic patent, as according to the CJEU ment of diabetes. The product at stake this compound then cannot any longer (Januvia®) comprises the active ingre- fall within the scope of the protection dient sitagliptin, a DP IV inhibitor. Si- conferred by that patent. L

Picture: Boehmert & Boehmert

36


European Biotechnology | Summer Edition | Vol. 19 | 2020

financial markets

The road to recovery goes via vaccines and antibodies Dr Yaron Werber, M.D., MBA  Managing Director, Health Care – Biotechnology;

Senior research analyst, Cowen Inc. If reopening the economy after the prolonged shutdown was the end of the beginning, then the successful development of vaccines and therapeutic antibodies has the potential to be the beginning of the end.

Co nsumer co nf idence to resume any semblance of a previrus level of activity will require vaccines or therapeutics that can be used prophylactically to prevent spread or at least mitigate disease severity. Vaccine development is in Hyperdrive and will have bumps.As biotech companies are progressing at a historic pace, including several with unproven technologies, there may likely be a high rate of failure among the over 150 vaccine candidates currently being studied. But that is ok and should in fact be expected and encouraged. The good news is that government and public funding in the U.S. and Europe and motivated regulatory agencies is expediting the time to market without sacrificing safety. More so, these funding sources are willing to partake in the risk associated with starting production months before final results are confirmed. Based on

current progress, we expect at least one vaccine to be available for emergency use in Q4/20 and multiple vaccines available for high-risk populations in Q1/21. Inoculation of the general public will likely not begin until mid-’21, thereby giving us some roadmap as to when economic recovery will start. A risk to the timing of the economic recovery pivots on the timelines for manufacturing scale up, but companies are making faster than expected progress on that front with more than a billion doses possible by the end of 2021 from Pfizer/BioNTech, Moderna, JNJ, AstraZeneca/Oxford University and GSK among others. Importantly, there could be a bottleneck in production if the raw materials become difficult to source. We estimate that hundreds of millions or even billions of doses will be

needed since it is unlikely for the world to reach herd immunity in the next 1–2 years at the current infection rate. Antibody therapy will be critical to bridge the gap before vaccines become widely available – antibody modalities are promising given historical successes. Before a viable vaccine is developed, there will be a significant demand for a temporary solution that can protect people from the COVID-19. This will be especially true if the current trend of increasing hospitalizations continues. Antibody therapy should come in time to bridge the gap to vaccines since candidates are being developed by Regeneron using established technology that was used to develop therapies to treat other viral diseases. Other companies such as GSK/Vir, Lilly, Amgen, AbbVie, Abcella, Junshi and Celltrion have also joined the race. The market opportunity for antibody therapy appears larger than for vaccines, though both may disappoint. L

Picture: Cowen Inc

News from the floor GenMab A/S  H.C. Wainwright analyst

Valneva SE   Following the licensing

Ram Selvaraju reiterated a Buy rating on Genmab A/S at the beginning of June, setting a price target of $34, which was 11.59% above the share price of $30.47 at that time. After a licence deal with Abbvie Inc (p. 64)in mid-June the share price climbed to $33,44. Selvaraju expected Genmab A/S to post earnings per share (EPS) of $0.00 for Q2/2020.

agreement for the Lyme disease vaccine from Valneva SE by Pfizer Inc, research analyst Simon Scholes of First Berlin Equity Research confirmed his Buy rating and increased the target price from €5.60 to €6.90. BIONTECH SE Following positive results

for the first of four COVID-19-mRNA vac-

cine candidates in the BNT162 program, SVB Leerink raised the price target for BioNTech SE from $37 to $42. Previously H.C. Wainwright analyst Robert Burns downgraded BioNTech to Neutral from Buy without a price target. The stock’s risk/reward ratio has become less attractive following the recent runup in the shares, Burns tells investors in a research note. L

37


38

financial markets

COMPANY

QUOTE

European Biotechnology | Summer Edition | Vol. 19 | 2020

M-CAP

52 weeks indicator low high

COMPANY

QUOTE

M-CAP

4basebio AG

2.14

96,800k

Bone Therapeutics SA

2.41

28,600k

4D Pharma plc

0.47

49,200k

Brain AG

8.38

166,800k

4SC AG

1.62

74,200k

C4X Discovery Holdings plc

0.16

19,200k

A1M Pharma AS

0.11

18,000k

Calliditas Therapeutics AB

10.48

515,000k

AB Science SA

8.98

406,300k

Cantargia AB

2.08

187,600k

Abcam plc

15.17

3,231,100k

Carbios SAS

23.10

161,000k

0.83

18,000k

Cassiopea SpA

38.87

415,800k

22.25

270,800k

Cellectis SA

16.52

702,400k

Acacia Pharma plc

3.30

211,700k

Cellink AB

12.88

539,100k

Active Biotech AB

0.24

35,800k

Celon Pharma SA

9.16

40,800k

Addex Therapeutics Ltd

1.32

44,000k

Celyad SA

9.33

128,700k

Abionix Pharma SA Abivax SA

Centogene NV

20.90

341,600k

Circassia Pharmaceuticals plc

0.27

104,100k

Co.don AG

1.35

48,300k

85.09

1,298,100k

Cosmo Pharmaceuticals NV

European Biotech Stocks The unique and most complete list of share price developments of biotech companies listed in Europe – exclusively in European Biotechnology Magazine.

7,600k

9.82

26,100k

Cyxone AB

0.58

28,200k

DBV Technologies SA

8.20

448,200k

Deinove SA

0.77

16,300k

Destiny Pharma plc

0.41

18,000k

Diamyd Medical AB

1.93

132,800k

Diasorin SpA

172.0

9,545,000k

Elanix Technologies AG

0.46

3,500k

e-Therapeutics plc

0.19

62,200k

Ellen AB

0.02

3,900k

Enzymatica AB

1.51

215,000k

Epigenomics AG

1.59

73,500k

Erytech Pharma SA

8.09

141,000k

8.50

57,900k

Esperite NV

0.03

1,500k

7.14

59,700k

Eurobio Scientific SA

8.48

95,100k

Eurofins Scientific SE

565.0

10,567,000k

1.06

Adocia SAS ALK-Abelló A/S

0.30

Cytotools AG

41,800k

ADL Bionatur Solutions SA Advicenne SACA

Curetis AG

241.61

2,669,400k

Allergy Therapeutics plc

0.16

99,100k

Evgen Pharma plc

0.11

14,400k

Alligator Bioscience AB

0.98

69,500k

Evolva SA

0.27

222,500k

Annexin Pharmaceuticals AB

0.19

13,300k

Evotec SE

24.31

3,679,000k

Aqua Bio Technology ASA

0.40

6,200k

Expres2ion Biotech Holding AB

2.57

42,000k

Argenx SE

211.0

9,889,000k

Faron Pharmaceuticals Oy

3.44

161,200k

Arocell AB

0.26

19,600k

Fermentalg SA

1.37

28,400k

Asit Biotech SA

0.19

4,100k

Formycon AG

23.0

227,000k

Avacta Group plc

1.47

371,800k

Fusion Antibodies Ltd.

1.15

23,600k

Avantium Holding NV

7.10

177,800k

Gabather AB

240.57

3,286,800k

Galapagos NV

Bachem Holding AG

0.65

8,900k

180.95

11,615,000k

Genedrive plc

1.24

66,100k

Geneuro SA

3.76

77,400k

4.90

189,600k

40.98

2,602,700k

Basilea Pharmaceutica AG

49.53

580,200k

Bavarian Nordic A/S

25.81

1,494,000k

3.71

321,500k

Genfit SA

Bioarctic AB

7.16

624,000k

Genmab A/S

Biocartis NV

4.49

249,200k

Genomic Vision SA

0.39

18,500k

Biofrontera AG

3.11

133,000k

Genovis AB

3.52

223,500k

50.29

871,800k

Genoway SA

2.12

15,500k

0.15

89,100k

Gensight Biologics SA

3.32

102,100k 78,900k

Bergenbio ASA

Biogaia AB Bioinvent International AB Biomed-Lublin SA Biomérieux SA BioNTech SE

1.88

109,800k

Gentian Diagnostics AB

5.12

129.40

15,044,000k

Genkyotex SA

2.23

25,900k

61.10

13,671,000k

Genus plc

39.82

2,547,800k

Biophytis

0.71

37,200k

Global Bioenergies SA

3.61

31,800k

Bioporto Diagnostics A/S

0.35

70,600k

Hansa Biopharma AB

20.97

867,600k 146,500k

Biosearch Life SA Biotec Pharmacon ASA Bioventix plc Biovica International AB

1.0

59,100k

Heidelberg Pharma AG

4.78

3.44

164,000k

Herantis Pharma Oyj

7.30

56,200k

47.22

245,900k

Hofseth Biocare ASA

0.89

293,200k

2.11

56,000k

1.16

178,500k

Horizon Discovery Group plc

52 weeks indicator low high


financial markets

European Biotechnology | Summer Edition | Vol. 19 | 2020

COMPANY Hybrigenics SA

QUOTE

M-CAP

0.19

42,200k

Idorsia Ltd.

29.96

4,206,600k

Immatics NV

13.20

754,900k

Immunicum AB

0.95

87,100k

Immunodiagnostic Systems plc

2.89

84,800k

Immunovia AB

52 weeks indicator low high

COMPANY

QUOTE

M-CAP

Oxford Biomedica plc

8.23

Oxurion NV

3.08

117,600k

Paion AG

3.16

199,400k

690,100k

PCI Biotech Holding ASA

7.04

263,300k

Pharma Mar SA

9.70

2,074,000k 799,500k

16.29

364,700k

Pharming Group NV

1.28

Immupharma plc

0.14

25,500k

Pharnext SA

3.47

58,000k

Index Pharm. Holding AB

0.57

50,800k

Photocure ASA

6.79

179,600k

Infant Bacterial Therapeutics AB

11.16

125,500k

Physiomics plc

0.07

6,700k

Innate Pharma SA

5.59

437,500k

Plant Advanced Technologies SA

20.0

18,200k

Polyphor AG

6.58

69,400k

7.15

201,400k

Integragen SA

1.57

10,700k

Intervacc AB

2.44

125,000k

Poxel SA

Inventiva SA

12.30

373,200k

Predilife SA

Isofol Medical AB

0.84

70,300k

Probi AB

ISR Holding AB

0.66

16,700k

Probiodrug AG

3.90

78,700k

Kancera AB

0.26

115,000k

Promore Pharma AB

0.44

16,000k

Karo Pharma AB

5.57

1,253,700k

Kiadis Pharma BV

1.42

55,400k

Qiagen NV

Proteome Sciences plc

6.75

19,900k

29.43

363,700k

0.04

13,700k

38.54

8,732,000k

Kuros Biosciences AG

2.17

47,100k

Q-Linea AB

8.25

223,900k

LIDDS AB

1.40

34,600k

Quantum Genomics SAS

2.90

55,000k

Lysogene SA

2.73

43,800k

Relief Therapeutics Holding AG

0.04

74,200k

Marinomed Biotech AG

92.0

134,000k

Reneuron Group plc

1.57

49,500k

MDxHealth SA

0.71

49,900k

Saniona AB

2.48

73,800k

Medigene AG

5.0

124,800k

Santhera Pharmaceuticals AG

7.76

100,500k

Medincell SA

7.32

164,900k

Sareum Holdings plc

0.01

18,900k

Medivir AB

1.55

35,400k

Scancell Holdings plc

0.06

29,200k

Mereo Biopharma Group plc

0.54

182,500k

Selvita SA

15.57

248,700k

Metabolic Explorer SA

1.46

40,900k

Sensorion SA

0.85

49,900k

Midatech Pharma plc

0.22

8,500k

Shield Therapeutics plc

1.0

124,200k 426,900k

Mithra

19.0

803,400k

Silence Therapeutics plc

5.20

Molecular Partners AG

14.21

300,800k

Simris Alg AB

0.10

2,200k

Molecular Medicine SpA

0.50

231,000k

Skinbiotherapeutics plc

0.19

23,800k

Mologen AG Morphosys AG

0.09

1,300k

117.50

3,846,000k

Softox Solutions AS Swedish Orphan Biovitrum AB

4.79

37,500k

20.76

6,231,000k 69,700k

Motif Bio plc

0.0

2,500k

Synairgen Research Ltd

0.47

Nanobiotix SA

7.37

166,800k

Targovax ASA

0.68

51,600k

18.30

359,500k

Theradiag SA

2.19

18,800k

10.40

38,000k

NattoPharma ASA Navamedic

1.88

27,800k

Theranexus SADIR

Neovacs

0.25

36,000k

Tissue Regenix Group plc

0.0

28,100k

Neurosearch A/S

1.70

38,800k

Tiziana Life Sciences plc

1.19

203,400k

Neurovive Pharmaceutical AB

0.01

1,800k

Transgene SA

1.44

120,900k

Newron Pharmaceuticals SpA

1.56

27,100k

Ultimovacs ASA

4.06

129,800k

Nicox SA

4.10

138,400k

Valirx plc

0.09

3,100k

Nordic Nanovector ASA

2.04

132,200k

Valneva SE

4.82

437,800k

Novact

3.21

218,600k

Vectura Group plc

1.09

654,900k

52.71

14,919,500k

Verona Pharma plc

0.55

58,600k

Noxxon Pharma NV

0.57

22,800k

Virogates A/S

8.79

27,100k

Oncimmune Holdings plc

1.45

92,100k

Vita 34 AG

12.60

52,200k 79,900k

Novozymes Biopharma DK A/S

Oncoarendi Therapeutics SA

3.75

51,200k

Vivoryon Therapeutics AG

3.95

Oncodesign Biotechnology SA

12.15

81,800k

Voluntis SA

1.28

9,700k

Oncology Venture A/S

0.14

22,800k

Xbrane Biopharma AB

6.86

129,900k

Oncopeptides AB

12.77

772,600k

Xintela AB

0.41

20,200k

Onxeo SA

0.76

45,500k

Yourgene Health plc

0.18

114,500k

Zealand Pharmaceuticals A/S

32.72

1,269,400k

Open Orphan PLC

0.13

87,800k

Optibiotix Health plc

0.57

49,800k

Orphazyme A/S

13.13

348,500k

Oryzon Genomics SA

3.30

168,700k

OSE Immuno

5.86

89,600k

Oxford Biodynamics plc

0.68

62,500k

52 weeks indicator low high

All quotes are listed in Euro. All data is provided without guarantee. The effective date is 7 July 2020 These dedicated biotech companies are listed on European stock markets.

39


2020 Delivered digitally

4th AMR Conference Novel Antimicrobials & AMR Diagnostics Over 400 international AMR experts from industry, SMEs, start-ups, big pharma, academia, clinics, regulatory bodies, investors, public institutions and policy will meet virtually at the 4th AMR Conference to network and discuss challenges and strategies for bringing new antimicrobial treatments and diagnostics to the market, and help establishing a post COVID-19 policy roadmap on AMR. Each conference day will cover a focus topic with LIVE sessions and high level panels. › Day 1: Lessons learned from COVID-19 › Day 2: Business Models & Policy Incentives › Day 3: Global Markets › Day 4: Financing & Investing › Day 5: Outlook & Roadmap Additionally, participants will be able to participate in virtual 1:1 partnering meetings, access academic poster presentations and our new digital AMR Stakeholder Guide.

amr-conference.com #AMRconference We are part of the #GlobalAMRChallenge

Organisation: BIOCOM AG I Lützowstraße 33–36 I 10785 Berlin I Germany amr@biocom.de I Tel. +49 (0)30 264921-38 I Fax +49 (0)30 264921-66

©Sebastian Kaulitzki/stock.adobe.com

24–28 August


European Biotechnology | Summer Edition | Vol. 19 | 2020

Updates on clinical trials COVID-19

ˆ

In June, researchers at AstraZeneca plc have started enrolment for a Phase II/III pivotal trial to test a COVID-19 chimpanese adenoviral vector vaccine (ChAdOx1) candidate licenced from the University Oxford. ChAdOx1 nCoV-19 is unable to replicate in humans. A Phase I study of the adenoviral vector vaccine developed by the British with the Dutch CDMO Halix NV and German tool provider Merck KGaA/Millipore began in April. In the Phase II/III study, the researchers plan to enrol up to 10,260 adults and children. Within the Phase II trial, the ChAdOx1 nCoV-19 vaccine or a licenced vaccine (MenACWY) that will be used as a control for comparison will also be tested in a small number of older adults and children. For adults aged 50 to over 70 and children aged 5 to 12, researchers will be assessing the immune response to the vaccine. The Phase III study is powered to assess how well the vaccine works to prevent people from becoming infected and unwell with COVID-19. If safe and efficient , the vaccine dubbed AZD1222 will be produced by Emergent Biosolutions Inc as part “Operation Warp Speed”, the US programme aimed to gain prefered access for the US to COVID-19 vaccines, and could gain US$1.2bn of funding . In June, Oxford-based Izana Bioscience Ltd’s GM-CSF-targeting arthritis antibody namilumab (IZN-101) was selected to be tested within the CATALYST clinical trial programme in 12 UK centres. The immunosuppressive antibody may help hospitalised COVID-19 patients improve before requiring intensive care. The adaptive CATALYST trial, running in Birmingham and in close collaboration with Oxford and University College London, will test a series of investigational and pre-approved drugs. Its adaptive trial design will enable the rapid comparison of the multiple interventions simultaneously, with up to 40 patients recruited to each arm. Those drugs that prove successful in CATALYST will be recommend-

ed for further testing within large ongoing national trials. Uncontrolled release of GM-CSF (granulocyte-macrophage colony stimulating factor) is believed to be a key element in the excessive and dangerous lung inflammation seen in COVID-19 patients. The trial will determine whether treating mildly symptomatic patients with namilumab before intensive care admittance or ventilation necessity can control the hyper-inflammatory host response to viremia. Namilumab has demonstrated efficacy and safety in a Phase IIb trial conducted in over 100 rheumatoid arthritis patients, and a phase II proof-ofconcept study in ankylosing spondylitis is ongoing. Staidson Biopharmaceuticals Co. Ltd (Bejing) and the Spanish CRO Pivotal S.L. (Madrid) announced, in mid-June, their plan to collaborate on a European clinical Phase II trial designed to treat 60 progressive severe COVID-19 patients with BDB-001, a recombinant, injectable, humanised, anti-human, selective C5a monoclonal antibody, that the Chinese company wants to develop for the Chinese market. The trial will complete a Chinese study for which the appropriate patient population is no longer available. In a preclinical model for the SARS-CoV2-related MERS virus, activation of the complement system boosted disease progression post infection stage, suggesting that C5a blockade may be an effective approach to reduce hyper-inflammation causing the pulmonary dysfunction observed in COVID-19 patients. The potential advantage of selectively blocking C5a without affecting C5b pathway is that the complement membrane attack complex (MAC) formation would not be altered, so the protection against several microbial infections, such as Neisseria meningitidis, would be preserved. NASH

ˆ

French POXEL SA (Lyon) will present data from a Phase IIa study in 100 pa-

Comprehensive support for your injectables For over 35 years, Vetter has been a trusted partner in injectables manufacturing for pharmaceutical and biotech companies around the world. Our deep expertise enables us to integrate with your team to design and implement a personalized plan for success in a shifting global marketplace. Our strategic partnership includes: Customized clinical and commercial manufacturing services for your product throughout its lifecycle Deep and comprehensive technical, analytical, and regulatory subject matter expertise Proven manufacturing processes that are flexible, efficient, and scalable Filling and packaging capabilities that utilize the latest technology to meet international market demands

Awarded state-of-the-art technologies and innovative processes

• • • •

infoUS@vetter-pharma.com infoAsiaPacific@vetter-pharma.com infoJapan@vetter-pharma.com info@vetter-pharma.com

www.vetter-pharma.com

Answers that work


Regulatory Affairs

European Biotechnology | Summer Edition | Vol. 19 | 2020

NASH with fibrosis

News Targeted drug delivery UCB SA (Brussels) has presented data from two Phase III studies – BE VIVID and BE READY – demonstrating that its IL-17F blocker bimekizumab helped patients with moderate-to-severe plaque psoriasis to improve significantly compared to placebo. Total skin clearance occured “in most patients“ at week 16 (90 percent improvement in the Psoriasis Area and Severity Index); patients responded after the first dose for up to a year. Bimekizumab was superior in skin clearance to ustekinumab; 58.6% of the bimekizumab group achieved PASI 100 compared to 20.9% of the group treated with Janssen-Cilag BV’s ustekinumab.

Parkinson’s progress Novo Nordisk A/S has presented data from a responder analysis, which showed that oral semaglutide 14 mg was more effective in achieving a blood sugar reduction of greater than or equal to 1% together with body weight reduction of greater than or equal to 5% compared to sitagliptin, empagliflozin, and liraglutide in people with type 2 diabetes. The composite endpoint of blood sugar reductions of greater than or equal to 1% and body weight loss of greater than or equal to 5% was achieved by 27% to 41% of people treated with semaglutide vs 11% of people treated with sitagliptin; 18% with liraglutide; 20% with empagliflozin, and 1 – 8% with placebo. Any reduction in blood sugar was seen in higher proportions of people treated with semaglutide (89 – 95%) than those treated with active comparators (82 – 88%) or with placebo (51 – 64%).

Healthy Liver

NAFLD (fatty liver)

NSAH (inflammation)

NASH with cirrhosis

NASH with cancer and cirrhosis

NASH with cancer, without cirrhosis Reversible (diet, exercise, weight loss, bariatrix surgery) Hardly reversible (transplantatioin)

Liver progression for non-alcoholic fatty liver disease

tients with nonalcoholic fatty liver disease (NAFLD), patients who will most likely develop NASH, receiving its adenosine monophosphate-activated protein kinase activator (AMPK) PXL770 in Q3/2020. Within the double-blind, placebo-controlled, 12-week study, patients receive three doses of PXL770 versus a placebo. The primary endpoint of the study is the change in the liver’s fat mass based on an MRI-estimated proton density fat fraction. The study will also assess the safety and tolerability of PXL770. In addition, the effect of PXL770 on hepatic lipogenesis and glucose tolerance will be investigated. In May, POXEL announced that PXL770 was also evaluated in rodent models of diabetic kidney disease (DKD), which also assessed cardiac dysfunction and adrenoleukodystrophy (ALD)/adrenomyeloneuropathy (AMN), a deadly, inherited, rare metabolic disease. Poxel conducted these studies as part of the investigation into a broader application of PXL770 in a range of metabolic diseases. Lung cancer

ˆ

AstraZeneca plc has presented tremendous Phase III data in the adjuvant therapy setting of EGFR-dependent, non-small cell lung cancer (NSCLC) at the first virtual meeting of the American Society of Clinical Oncology (ASCO). The company’s kinase blocker osimertinib (Tagrisso), which was approved as first-line treatment for metastatic EGFR-mutated NSCLC, re-

duced the risk of death by 79% in 339 patients with stage IB-IIIA with EGFR-mutated lung cancer. The ADAURA Trial was unblinded early, as Tagrisso demonstrated an unprecedented disease-free survival rate of 89% for all patients treated that were were alive and disease-free, compared with 44% and 53% in the placebo arm after two years of treatment. These results demonstrate, for the first time, that an EGFR blocker can change the course of early-stage, esectable, EGFR-mutated lung cancer, boosting the US$3.2bn market share of osimertinib significantly. According to estimates, the patient population with adjuvant NSCLC makes up a quarter of all NSCLC patients. Lung cancer will be the most lucrative indication of entrectinib (Rozlytrek), Swiss Roche AG’s inhibitor of the receptor tyrosine kinases TRKA, -B and -C, ROS, and ALK, which contribute to cancer development when permanently overexpressed. In a pivotal basket trial, in 87 patients preselected for appropriate gene fusions, the personalised cancer medicine showed high promise in inresectable, advanced, and metastatic tumours. The kinase blocker showed such a strong reduction in tumour proliferation and induction of apoptosis, that the European Medicines Agency’s (EMA) medical committee (CHMP) recommended EU market approval in solid tumours that overproduce TRK and

Pictures: Signimu/wikimedia

42


Regulatory Affairs

European Biotechnology | Summer Edition | Vol. 19 | 2020

patients with ROS1-positive, advanced, non-small-cell lung cancer. The EMA’s decision was based on the results of the Phase II STARTRK-2, Phase I STARTRK-1, and Phase I ALKA-372-001 studies, and the data from the Phase I/II STARTRKNG study. According to these data, tumours shrank in more than half of the patients with NTRK-fusion-positive, locally advanced, or metastatic solid tumours (overall response rate = 63.5%; N = 74), and objective response rates were observed in 14 tumour types (median response time [DoR] = 12.9 months). In ROS1-positive, advanced, non-smallcell lung cancer (NSCLC), the tumour shrank due to entrectinib in 73.4% of patients (ORR; N = 94) at 12 months’ follow-up, with a median response time [DoR] of 16.5 months. In patients with metastases of the central nervous system, a response was observed in 67.1%, six months after treatment. Glioblastoma

ˆ

Pictures: xxx

On behalf of the virtual ASCO annual meeting, Swiss-German VAXIMM AG has presented preliminary, open-label safety and efficacy data from a Phase I/ II trial, enrolling 30 patients with recurrent glioblastoma who were treated with a combination of Merck KGaA’s injected PD-L1 blocking medicine avelumab and VAXIMM’s experimental T-cell booster VXM01. Three out of nine patients dosed

with the combination had partially objective responses, namely shrinking of 58 – 95% of the tumour size, two of them halting disease progression for more than six months. No treatment-related toxicities were observed in the nine patients treated. VXM01 is designed to activate T-cells to attack the tumour vasculature and, in several tumour types, attack cancer cells directly. It is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to carry vascular endothelial growth factor receptor-2 (VEGFR2) as the target gene. VXM01 stimulates the patient’s immune system to activate VEGFR2-specific, cytotoxic T-cells. Destruction of cells in the tumour vasculature, lead to an increased infiltration of immune cells into the tumour. Glaucoma

ˆ

French Nicox SA has launched an adaptive designed Phase III trial of its prostaglandine amid (bimatoprost analog) NCX 470 in glaucoma patients. More than 600 patients with open-angle glaucoma or ocular hypertension will be enrolled at multiple US and Chinese testing sites to receive an ophthalmic solution, 0.065% and 0.1%, of the company’s second-generation nitric oxide (NO)-donating bimatoprost analog vs a latanoprost ophthalmic solution, 0.005%. The primary endpoint is time-matched reduction in intraocular pressure after two, six, and

twelve weeks of treatment. In the Phase II Dolomites trial, NCX 470 demonstrated both statistical non-inferiority and superiority to latanoprost, the US standard of care for patients with open-angle glaucoma and ocular hypertension, and the market leader in prostaglandin analog prescriptions. In 2019, worldwide sales of treatments targeting glaucoma were over US-$6bn out of a US-$21.9bn global market for ophthalmic drugs. Equine Encelphaltis

ˆ

Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) has announced Phase I results of MVA-BN ® WEV, its firstin-class preventive vaccine candidate against the Western, Eastern, and Venezualian equine encephalitis virus. Data from 45 heathy volunteers demonstrated that the vaccine was well tolerated and immunogenic across all all dosing groups. Neutralising antibody responses were observed in all dose groups, with peak levels reached after the second vaccination. Responses were detected as early as two weeks after the first vaccination in the highest dose group, in which a complete seroconversion was also observed after the second vaccination, four weeks after the first vaccination. The most common vaccine-related adverse event was injection site pain. All three viruses are considered to be potential biological threats. L

43


44

Regulatory Affairs

European Biotechnology | Summer Edition | Vol. 19 | 2020

Use of real world data Beyond COVID-19 The EMA, togeth-

er with EU member states and the European Commission, has published principles on how the network will ensure that core public and animal health regulatory activities, such as the authorisation, maintenance, and supervision of human and veterinary medicines, will continue to be executed during the ongoing COVID-19 pandemic. Besides monitoring vaccines and treatments against

the novel virus SARS-CoV-2, the plan ensures that the EU regulatory system continues to address all other patients’ needs. Thus, it delineates how assessments of non-COVID-19-related medicines will be undertaken during the COVID-19 pandemic, irrespective of whether they are centrally or nationally authorised. The plan indicates how the EU member states must consider their resources

www.ema.europa.eu

and capacities, to prevent delays in the assessment of non-COVID-19-related medicines. According to the EMA, the plan will be reviewed regularly and revised as needed. L

Recommendations from the EMA: MA (market authorisation); cond. MA (conditional MA); ODD (orphan drug designation)

Drug name

Indication

Company

Status

› Enerzair breezhaler (indacaterol/glycopyrronium/ mometasone furoate); Zimbus Breezhaler (indacaterol/glycopyrronium/mometasone furoate)

Treatment of asthma

Novartis Europharm Ltd

MA rec.

› Zercepac (biosimilar trastuzumab)

Treatment of breast and gastric cancer

Accord Healthcare SLU

MA rec.

› Daurismo (glasdegib)

Treatment of acute myeloid leukaemia

Pfizer Europe MA EEIG

MA rec.

› Reblozyl (luspatercept)

Treatment of adults with transfusion-dependent anaemia associated with myelodysplastic syndromes or beta-thalassaemia

Celgene Europe BV

MA rec.

› Insulin aspart Sanofi (biosimilar insulin aspart)

Treatment of diabetes mellitus

Sanofi-Aventis group

MA rec.

› Cabazitaxel Accord (cabazitaxel)

Second-line treatment of patients with hormone refractory metastatic prostate cancer pretreated with a docetaxel-containing regimen

Accord Healthcare SLU

Hybrid MA rec.

› P aliperidone Janssen-Cilag International (paliperidone)

Treatment of schizophrenia

Janssen-Cilag International NV

Informed consent MA rec.

› Rozlytrek (entrectinib)

Treatment of solid tumours overexpressing TRK due to NTRK gene fusions, or non-small cell lung cancer overexpressing ROS due to ROS1 fusions

Roche Registration Ltd

cond. MA rec.

› Zabdeno (Ad26.ZEBOV) + Mvabea (MVA-BN-Filo)

Prevention of Ebola virus disease in individuals aged one year and older

Janssen-Cilag International NV

MA rec.

› Hepcludex (bulevirtide)

Treatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease

MYR GmbH

cond. MA rec.

› Zolgensma (onasemnogene abeparvovec)

Treatment of spinal muscular atrophy in infants with functional mutations in the SMN1 gene or with SMN2 trisomy

AveXis EU Ltd

MA rec.

› Pretomanid FGK

Treatment of tuberculosis, in combination with bedaquiline and linezolid

FGK Representative Service GmbH

MA rec.

› Zeposia (ozanimod)

Treatment of adult patients with relapsing remitting multiple sclerosis.

Celgene Europe BV

MA rec.

›N  epexto (biosimilar etanercept)

Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and paediatric plaque psoriasis

Mylan IRE Healthcare Ltd

MA rec.


25 years of IZB – the dynamism of Europe’s Hotspots for Life Sciences is unbroken The Innovation and Start-up Center for Biotechnology on the Martinsried Campus pursues research into therapies and medicines for the most serious diseases The Start-up Center started in 1995 with 1,000 m2 of laboratory and ofďŹ ce space and ďŹ ve biotech start-ups. Today the IZB with its locations in Planegg-Martinsried and Freising-Weihenstephan has developed into one of the leading biotechnology centers in Europe. Currently over 50 biotech companies with more than 600 employees are located over an area of 26,000 m2 . Dr. Peter Hanns Zobel has now been Managing Director of the business incubator for 24 years. He tirelessly drives forward the expansion and constant

development of the location. Here people work on developing drugs for the most serious diseases, such as cancer, Alzheimer‘s or various autoimmune diseases – and there have been many successes. COVID-19 projects at the IZB Also in times of the corona crisis, IZB entrepreneurs are also among those working on futureoriented solutions. In summer 2020, GNA Biosolutions will launch a corona rapid test. Immunic Therapeutics is entering into a clinical Phase 2 trail for a COVID-19 medication,

ê%HFDXVHRILWVćH[LELOLW\WKH,=%KDVHQDEOHGXVWR ê/RFDWHGLQWKH,=%DWKRPHLQWKHZRUOGüIURPKHUH VXVWDLQDEOHJURZIURPLQLWLDOO\WRHPSOR\HHVDQG ZHVHUYHFXVWRPHUVLQFRXQWULHVÍ VXSSRUWHGXVLQRXUIXUWKHUGHYHORSPHQWê Dr. Marion Jung, CHROMOTEK GMBH Michael Scholl, CEO, LEUKOCARE AG

and Eisbach Bio has started developing a new, speciďŹ c active agent against SARS-CoV-2 virus. With an European consortium, LEUKOCARE AG is developing a vaccine against COVID-19. Exosome Diagnostics, a developer of liquid biopsy tests, is performing COVID-19 tests in its clinical laboratories at the IZB. The tests are available to the public through a network of doctors (www.corona teststelle.de) as well as companies and groups under munich@exosomedx.com. Ella Biotech also supplies many companies with building blocks (oligonucleotides) for corona tests.

ĂŞ$VSDUWRIWKH,=%QHWZRUNZHZHUHDEOHWRJURZ IURPDVWDUWXSWRD1DVGDTOLVWHGFRPSDQ\ZLWKLQ WKUHH\HDUVĂŤ Dr. Daniel Vitt, CEO, Dr. Hella Kohlhof, CSO, Dr. Manfred GrĂśppel, COO, Dr. Andreas MĂźhler, CMO, IMMUNIC THERAPEUTICS (from left to right) Advertorial


MANAGING DIRECTOR DR. PETER HANNS ZOBEL HAS BUILT UP THE IZB INTO AN INTERNATIONALLY RECOGNIZED BIOTECHNOLOGY LOCATION WITH EXCELLENT INFRASTRUCTURE

The ďŹ rst generation at the IZB were biotech companies such as MorphoSys, MediGene and Micromet. Who would have thought that these very ďŹ rst companies at the IZB would eventually develop into the most renowned biotech companies of Germany. MorphoSys, with a market capitalization of 3.6 billion dollars (as of July 1, 2020), soon approaches the approval of its ďŹ rst drug. Micromet, which specialized in developing cancer drugs, was sold to Amgen in 2012 for 1.16 billion dollars after just seven years. By 2001, the second generation of biotech entrepreneurs had moved into the IZB, including the companies 4SC, Menlo Systems, Pieris pharmaceuticals, Proteros Biostructures and TRION Research. As part of the Bavarian cluster offensive, the Biotech Cluster, called BioM, was created at the site. In 2006, the companies AMSilk, Coriolis Pharma

Research, SIRION BIOTECH and SuppreMol, moved their headquarters to the IZB. In 2015, SuppreMol was sold to Pharmaceutical company Baxter (now Shire) for 200 million Euro. The company developed treatment options for autoimmune diseases and allergies. In the same year a promising company, Rigontec, moved from Bonn to Martinsried, and two years later was sold to MSD. The company, under the management of Dr. Christian Schetter, received up to 464 million Euro for innovative immunotherapy in 2017. Exosome diagnostics, an American company that develops molecular diagnostic tests, under the direction of Dr. Mikkel Noerholm, chose the IZB as its European development location in 2010. Bio-Techne Corporation acquired Exosome Diagnostics in 2018 for up to 575 million dollars. “From 2015 to 2018 alone, IZB ďŹ nan-

cing and deals involved a total of 3.75 billion Euro,� says Dr. Peter Hanns Zobel, pleased about his start-ups. Let us see what the future brings. In 2019, nine new startups moved into the IZB: Catalym, Eisbach Bio, EpiQMax, kbms, MetaHeps, MODAG, OmicEra Diagnostics, ShiRhom and Sirana Pharma. Top research on the Martinsried Campus On the life science Martinsried Campus, teaching, basic research and clinical research, as well as technological innovations are combined in one location. The close proximity to top researchers on campus is precisely what makes the location so attractive. Here you meet Nobel Prize winners, directors or junior group leaders at the Max Planck Institute for Biochemistry and Neurobiology, professors and scientists at the Ludwig Maximi-

/DERUDWRULHVDWWKH,=%%LRWHFK3UHVV/RXQJH)HE'U&KULVWLDQ7KLULRQ6,5,21%LRWHFK&(2'U/XW]*%RQDFNHU&6/%HKULQJ6HQLRU9LFH3UHVLGHQW *HQHUDO0DQDJHU&RPPHUFLDO2SHUDWLRQV(XURSH(OLVDEHWK'RVWHUWHGLWRUQHZVSDSHU6žGGHXWVFKH=HLWXQJ'U3HWHU+DQQV=REHO0DQDJLQJ'LUHFWRU,=% 0DUF)LOHUPDQ*HUPDQ$FFHOHUDWRU/LIH6FLHQFHV&(2


lian University, or the excellent physicians at the Grosshadern Clinic, and top researchers at the Helmholtz Center. The biotech startups are often spin-offs from the surrounding institutes. These short distances encourage interactions and cooperations between the biotech companies and research. Magnet for biotech start-ups Anyone who has started at the IZB is reluctant to leave this hotspot for life sciences, and mostly moves to the neighboring industrial area in Planegg. The IZB offers an optimal infrastructure for converting biotech sector products or services into business concepts. S1 laboratories and ofďŹ ces at fair rental prices, internal property management, facility services on site, close contact with the venture capital scene, as well as joint location marketing are also factors for success, as well as the exibility to adapt the space required to the development of the start-ups. For more physical needs, the CafĂŠ Freshmaker opened in 2001, and the restaurant SEVEN AND MORE in 2014. Since 2002, two nurseries and kindergartens have gradually grown at the IZB. For 13 years Dr. Zobel chaired the board of Kita BioRegio e.V., and established a children’s center, with bilingual childcare staff, ecological food and a children’s laboratory that is second to none. To meet the high demand for BTAs (biological technical assistants) and CTAs (chemical technical assistants), Zobel located the Dr. Elhardt Chemistry College at the IZB in 2010. Modern infrastructure Competence is needed to successfully conduct cooperation talks with investors or partners; but a nice environment naturally contributes to a relaxed discussion atmosphere. Since it opened in 2014, the IZB Residence ÂŹCAMPUS AT HOME has been accommodating visiting scientists and business travelers in 42 rooms and suites. On the top oor of the building is the Faculty Club G2B, where members with their guests can view the Alps, while conjuring up cooperations or planning new projects. Five other conference rooms are available to IZB start-ups and external guests for meetings. Attractive network events The monthly series of events at the IZB are very popular. The IZBrunch brings together

The Faculty Club at the IZB

A conference room at the IZB

IZB Residence CAMPUS AT HOME

the scientists on campus and start-up companies. Everyone presents their research in an informal atmosphere and networks at a business lunch in the Faculty Club. Three times a year a biotech press lounge also takes place here. Three multipliers from the biotech, pharmaceutical and VC sectors present their company or research to around 100 guests. Once a year, together with the High-Tech GrĂźnderfonds and other partners such as Bayer, Boehringer Ingelheim or Merck, the IZB organizes a Life Science Pitch day. Here, ten to twelve start-ups

have the opportunity to present their work and consolidate early contacts with over 20 investors. Some start-ups were indeed funded in this context and moved into the IZB. The most recent example: MODAG. If you would like to participate in any of these events, please send an email to izb@izbonline.de. More information at: www.izb-online.de $XWKRU6XVDQQH6LPRQ +HDGRI3UHVVDQG3XEOLF5HODWLRQVDWWKH,=%


IZB Martinsried:

Small Molecules

MenloSystems GmbH

XL‡«ÀœÌiˆ˜

IZB Weihenstephan:

Superior Biopharmaceuticals

MenloSystems GmbH

MenloSystems GmbH

1 2 3 4

Innovation- and Start-up Center for Biotechnology IZB Max-Planck-Institute for Biochemistry

5 6

Max-Planck-Institute for Neurobiology

7

Biology Faculty at the LMU* Graduate School of Systemic Neurosciences(GSN) and Munich Center for Neurosciences Brain and Mind LMU*

8

BioM Biotech Cluster Development GmbH

Neurological Research Center of the LMU*

13

Center for Stroke and Dementia Research of the LMU*

10

Helmholtz Center Munich Institute for Molecular Immunology (Hematology Unit)

14

BioSysM the Bavarian Research Center for Molecular Biosystems of the LMU*

11

Center for Neuropathology and Prion Research of the LMU* (ZNP)

15

12

Gene Center of the LMU* and Institute for Biochemistry

16

9

Biomedical Center of the LMU*

Clinic Grosshadern of the LMU*

Pharmacy and Chemistry Faculty of the LMU*

Surgical Center of the LMU* Clinic Grosshadern

Department of Chemical epigenetics of the LMU

* LMU = Ludwig-Maximilians-Universität

* LMU = Ludwig Maximilian University Munich

13 15

8

16

7

MÜNCHEN/ MUNICH

9 10

14

11 12

6

4 1

5

3 2


European Biotechnology | Summer Edition | Vol. 19 | 2020

Seasoned lead Deinove SAS Montpellier-based Deinove SAS has named a new Chief Executive Officer. Alexis Rideau took over the helm of the company in May. Rideau is considered to be very experienced in the development, negotiation and implementation of strategic partnerships in the life sciences field, particularly in microbiology apAlexis Rideau plied to health and infectious diseases. Prior to joining the French biotech company, Rideau was in charge of developing industrial relations and coordinating the strategic partnership team at Bioaster (Lyon/Paris), a Technology Research Institute in applied microbiology, which specialises in the design and use of technology innovations in the field of microbiology. Before that, Rideau held various positions in companies like Library House Ltd, Bionest Partners and Glaizer Group, MorphoL Sys AG or Bio-Rad Laboratories. 

Pictures: Deinove/Evox Therapeutics/Ipsen Pharma/Biognosys/BioAscent/MaaT Pharma

Now with CMO Evox Therapeutics Ltd  Oxfordbased Evox Therapeutics Ltd. appoints Sonya Montgomery in the newly formed position of Chief Medical Officer. She has worked in the Life Sciences for almost 25 years and joins the exosome therapeutics company Evox from Gyroscope Therapeutics. There, she held the position of Vice President, Head of Clini- Sonya cal Development. Montgomery Prior to this, she was VP Clinical Development at ProQR where she led the company’s cystic fibrosis business. In 2012, Montgomery worked at Re-

lypsa as Executive Director Clinical Development and led a pivotal programme in the EU and US for patiromer (Veltassa) treating hyperkalaemia in chronic kidney disease and heart failure. L

New at the helm Ipsen Pharma SA David Loew, formerly executive vice president of Sanofi Pasteur, was appointed as CEO of French Ipsen Pharma SA at the beginning of July. Loew will be taking over from interim CEO Aymeric Le Chatelier, who was serving after David Meek’s departure at the end of 2019. Le Chatelier will continue his role as Chief Financial Officer. Loew started his career at David Loew ­Roche in 1992. In July 2013, he joined Sanofi as Senior Vice President Commercial Operations Europe. In 2016, he was appointed as CEO of Sanofi’s vaccine unit at Sanofi Pasteur. He left the company due to management changes by the new Sanofi CEO Paul Hudson.  L

Chair on board Biognosys AG  The proteomics specialist Biognosys AG announces the appointment of Patrick Vink as Chairman of the board. Before joining Biognosys Vink was COO at Cubist Pharmaceuticals Inc. He was responsible for the worldwide commercial and technical operations, and global alliance management. Prior that, Vink held Patrick Vink various positions at Mylan Inc, Sandoz, Biogen Inc, SanofiSynthelabo, and Numico. L

biopeople

US growth BioAscent Discovery Ltd  Nick Moore now supports Scottish BioAscent Discovery Ltd in further developing its business in North America. The internationally recognised drug discovery specialis t ha s more than 35 years experience – from early compound identification to clinical proof of concept. In 1999, he and his colleagues from Eli Nick Moore Lilly received the Society for Medicines Research Award for Drug Discovery for olanzapine, an atypical antipsychotic primarily used to treat schizophrenia and bipolar disorder. Before joining BioAscent, he was working for Charles River Discovery Services.  L

Business boss MaaT Pharma SA Savita Bernal has taken over from Jean-Marc Renard as new Chief Business Officer at Lyon-based MaaT Pharma. Bernal will lead the business and corporate development activities, from the clinical stage company with focus on microbiome-therapeutics. She came from Adocia. There she was responsible for outlicensing deals and Savita Bernal R&D collaborations with major ­biopharmaceutical companies. She led cross-functional teams and contributed to the company’s strategic decisions on its drug development programs ranging from preclinical to Phase III studies. Before this, she served at e(ye)Brain, and was a Senior Consultant in the Life Sciences division of Ernst and Young in Paris. Bernal studied Cognitive Neuroscience (PhD) and Cognitive Science (Master). L

49


AI

Patient data grows more readable for machines by the day. Has the Biohacking Era dawned with the advent of Big Medicine? There’s no longer a way to get around machine analysis of personal medical information, because it has the potential to significantly improve diagnosis, therapy and healthcare decisions. Under the FAIR guidelines, the biopharma industry is taking an approach to data acessibility in AI-driven research that seeks to strike a balance with protecting patient data.

European Biotechnology | Summer Edition | Vol. 19 | 2020

Pictures: xxx

50


AI

European Biotechnology | Summer Edition | Vol. 19 | 2020

My robot doctor – a new age in medicine Deep learning  The machines take over – it’s the backdrop for countless science fiction novels.

Will it happen first in medicine? Self-learning algorithms are already helping oncologists analyse Big Data, and a flood of new publications suggest they already outperform trained experts in image-, sequencingand clinical data-based diagnosis. Pharma giants have cracked open the door to machines choosing drug candidates, and are using them to analyse deficient signaling pathways that lead to cancer and other health threats. So what impact will AI have on health systems – and patients?

Pictures: pinkeyes/stock.adobe.com (left), Indivumed Group (right)

I

n tandem with accelerating developments in computing, data processing, and artificial intelligence (AI)-driven analytics, advances in the biological sciences are fueling a new wave of innovation that could have a significant impact in a wide range of sectors – from healthcare and agriculture to consumer goods and energy. That’s the outlook that sets the tone for the new McKinsey Global Institute report “The Bio Revolution”. According to senior partner Matthias Evers and his co-authors, transformative “new methodologies, including automation, machine learning, and proliferating biological data are enhancing discovery, throughput and productivity in R&D.” Self-learning algorithms that allow both automatic interpretation and comparison of next-generation sequencing (NGS) as well as diagnostic imaging data – and which additionally integrate the current knowledge on coronaviruses – are not just being used to find drugs and targets that could help arrest the current COVID-19 pandemic (see interview pp. 60-61). They also have the potential to improve productivity across the entire diagnostic and therapeutic pipeline. And some applications go far beyond that. According to the report, in human health alone, at least 45% of the global disease burden could be addressed if existing scientific data were findable, acces-

sible, interoperational and reusable (FAIR) by machines, particularly in an automated manner. Depending on how quickly the technologies are adopted, the authors estimate economic potential among all biologic applications in the next 10 to

Prof. Dr. HaRtmut Juhl  Founder and CEO Indivumed Group, Hamburg, Germany

?

How important do you think self-learning algorithms will be to cancer diagnosis in the future?

!

Deciphering the biological complexity of cancer is the future of precision oncology. AI-based algorithms are essential for achieving this goal, because they enable highly efficient drug development and patient diagnostics for personalised medicine.

20 years of US$2tn-$4tn annually (see Fig. 1, p. 52).

Stripping disease to its basics Just as with human intelligence, there’s no single accepted definition for AI. In simple terms, however, it includes all attempts to transfer human learning and thinking to a computer system so it can solve problems independently. Normal, rule-based systems written by programmers are not AI, because they are for example unable to recognise an image of the same person in fog, rain, backlight, with a beard or clean-shaven, etc. AI algorithms, on the other hand, can learn to distinguish people from existing images or data. And they can do the same for tumours or tissues. By applying the rules they learn to billions of new images, they can recognise patterns in Big Data sets. The same applies to other analytical data from the life sciences laboratory. The combination of machine-readable Big Data and its analysis via AI therefore offers hitherto unimaginable possibilities for the life sciences. In the analysis of both structured and unstructured data, self-learning algorithms are far superior to rule-based software. One AI field of application that’s being heavily investigated by numerous companies is cancer. For instance, pharma

51


52

AI

European Biotechnology | Summer Edition | Vol. 19 | 2020

The Bio Revolution Four arenas of biological innovations

Biomolecules Mapping and engineering intracellular molecules

Biosystems Mapping and engineering cells, tissues and organs

Biomachine Interfaces Connecting nervous systems of living organisms to machines

Biocomputing Using cells and cellular components for computation

The scope and scale of the impact on economies, societies and businesses could be substantial

60%

45%

of the world’s physical inputs could be made using biological systems

30%

of the world’s disease burden could be addressed

of R&D could be spent on biologyrelated industries

There’s a pipeline of applications in a range of domains Transformative new capabilities …

Bio-based materials production Personalised and precision products and services Engineered organisms Higher bio-based R&D productivity Bio-machine interfaces and computing

… across domains …

… but risks and issues to manage

Examples of applications Agriculture Meats produced without animals

Health Monogenic diseases prevented at birth

$2t–$4t

Energy and materials Synthetic silks produced by microbe factories Consumers Personalised diets based on your genome

Self-replicating bio crossing borders Unintended consequences Low barriers to potential misuse Hard to forge consensus Privacy and consent concerns Inequitable access or effects

of annual direct economic potential globally in 2030–40

Stakeholders must act if we are to capture the benefits of the Bio Revolution, while engaging together in a sustained dialogue about how to use these innovations Source: ©McKinsey Global Institute


European Biotechnology | Summer Edition | Vol. 19 | 2020

Artificial Intelligence Any technique that enables computers to mimic human intelligence, using logic, if-then rules, decision trees, and machine learning (including deep learning).

Machine Learning A subset of AI that includes abstruse statistical techniques that enable machines to improve at tasks with experience. The category includes deep learning.

Deep Learning The subset of machine learning composed of algorithms that permit software to train itself to perform tasks, like speech and image recognition, by exposing multilayered neural networks to vast amounts of data.

Fig. 2: Diagramme overview of the differences between different layers of artificial intelligence applications

and diagnostics giant Roche has built a unique portfolio of capabilities through M&As or partnerships that links analysis of cancer mutations with kinase profiles from patients, as well as image and meta­bolic data analysis with individual patient data and treatment results.

Pictures: Pistoia Alliance Ltd

A smorgasbord of applications As early as 2018, Roche and imaging specialist GE Healthcare entered into a partnership aimed at establishing “an industry-first digital platform” to allow the seamless integration and analysis of invivo and in-vitro data, patient records, medical best practices, real-time monitoring and the latest research outcomes for clinical decision support of doctors in oncology and intensive care units. “With today’s means of artificial intelligence, but also numerous other data analysis methods, we are able to decipher the variety of information from multiomics data of tumours together with individual clinical information,” says Prof. Dr. Hartmut Juhl (see p. 58-59). “However, in order to be able to measure these comprehensive biological data in a meaningful and comparable way,“ adds the CEO of Indivumed Group, “it is essential that the biological samples – i.e. the tumour tissues – are not only collected according

to strict and uniform standards in each patient, but are also well documented and shock frozen within minutes of surgical removal.” Studies have shown that expression patterns change significantly 10 to 20 minutes after a biopsy is taken.

The goal? Data-driven medicine Commercial stakeholders have insisted for some time that integrating clinical, imaging and data on the mutational status of tumours is one Holy Grail in digitalised medicine. That’s because it promises to ease health technology assessment (HTA) and pricing based on real­-world data, and also encourage recruitment of appropriate patient collectives for clinical trials. Patients would benefit from the results of such correlation analyses, as they could pinpoint the treatments most likely to show an effect from a patient’s unique data. By leveraging genetic data and data from clinical trials and treatments, Deep Lens Inc.’s VIPER platform already matches cancer patients to treatments and appropriate clinical trials. And oncology is just one potential field that could benefit hugely from self-learning algorithms and AI applications. Some reports from journals leave the impression that self-learning algorithms

Sie sind tätig in

Erforschung, Entwicklung, Zulassung oder Überwachung von Arzneimitteln und/oder Medizinprodukten? Dann sind Sie bei uns in bester Gesellschaft!

Jetzt Mitglied werden! dgpharmed.de/mitglieder


54

AI

European Biotechnology | Summer Edition | Vol. 19 | 2020

Master Data

Service 1 Terminology

Contacts

Service 2 Data Blueprint

External Data Providers

Data Loader

API

Triggers QC QC Feedback

Repositories

Stores QC Rules

Quality Services

QC Restults

Reference Data Conformance Reconciliation QC

 Part of EDISON  

QC

 External Systems  

Scientific QC

 External To Roche

Source: Roche AG

Roche has piloted an in-house system called EDISON that addresses some of the root causes of low data quality by harmonising and automating the process in which clinical sample metadata and data not compliant to CFR part 11 is defined, acquired and shared for further analysis. The core concepts behind the platform are data blueprints that describe the data that should enter Roche, leveraging global data standards and welldefined terminologies, and a service that allows the data to be quality-assured as early as possible in the process. That helps prevent cumbersome and resource-intensive internal integration and curation efforts (FAIRification) later.

already perform better than experienced specialists – when compared to pathologists in the diagnostic image evaluation of biopsies, for example. Other reports suggest that McKinsey’s “Bio Revolution” is already taking place.

Still the early, heady days Among the recent headlines was one that researchers at MIT had designed an algorithm that autonomously found the first AI-identified antibiotic – a compound subsequently named halicin. Companies like Insilico Medicine and Nanome.ai have described 10 potential small-molecule inhibitors targeting the SARS-CoV-2 main protease that were generated using AI. British-based AI VIVO reported that its platform identified the corticosteroid dexa­m ethasone as having high potential in the treatment of COVID-19. Two months later, the drug was found to re-

duce COVID-19-mortality significantly in the UK ‘Recovery’ study, which reported that it had saved one in eight ventilated COVID-19 patients. What AI VIVIO didn’t add in the announcement was that its algorithm also identified the anti­malarial chloroquine as a promising candidate drug. Clinical combination trials involving chloroquine and hydroxy­ chloroquine were recently halted by the World Health Organisation (WHO) after some subjects developed severe side effects. Most biased results from machine learning efforts result either from the limited availability of high-quality data to train the algorithms or imprecise definitions of the outcome of interest. In addition, some algorithms – particularly those based on artificial neural networks – often make inscrutable predictions, and it’s also harder for such algorithms to detect error or bias.

Preparing for the Age of AI Despite the numerous problems that remain to be solved, Big Pharma and partners are already preparing for the new

Artificial Intelligence Artificial intelligence is the term applied to computer programmes that do something we view as ‘smart’. The technology can be categorised into three groups — weak or narrow AI, artificial general intelligence (AGI) and superintelligent AI. Narrow AI is skilled at just one specific task, while AGI programmes could in theory successfully perform the same range of intellectual tasks that a human being can. Superintelligent AI would takes things a step further. It would be able to outperform even the best human brains in practically any field, particularly in those involving repetitive tasks. Machine learning is a subset of AI. In t­heory, the more data that machines access, the more they can ‘learn’. So ma-

chine learning systems can quickly apply knowledge and training from large datasets to excel for instance in fields like diagnostic image recognition, pattern recognition and predictive diagnostics. Deep learning is a subset of machine learning. Deep artificial neural networks are sets of algorithms that achieve new levels of accuracy for problems like image recognition. They use machine-learning techniques to solve real-world problems by tapping into neural networks that simulate human decisionmaking processes. They also require huge data­ sets to train themselves, because of the huge number of parameters that must be understood – which means initially they can generate many false-positives.  L


NEW: Bioprocess control station

One for All SciVario® twin – Innovative, Intuitive, Intelligent It does not matter with which organism you are working with now, or in the future. SciVario twin is our intelligent solution for your changing needs. The innovative bay-drawer system allows for the flexible adaption to your needs. The integrated, improved TMFCs and pumps allow the individual or parallel control of up to two vessels in a range of 0.7 L up to 3.8 L.

> Innovative: Personalize your SciVario twin according to your needs with the flexible bay-drawer system. > Intuitive: Easily set-up your process with the integrated VisioNize® onboard software. > Intelligent: Automated detection and recognition of plugged-in devices.

www.eppendorf.com/scivario Eppendorf®, the Eppendorf %UDQG'HVLJQ, BioBLU®, SciVario® and VisioNize® are registered trademarks of Eppendorf AG, Germany. All rights reserved, including graphics and images. Copyright © 2020 by Eppendorf AG.


AI

age of data-driven sciences. The DRAGON consortium led by Belgian Onco­radiomics BV, for example, will be funded under the Innovative Medicines Initiative (IMI)’s €72m COVID-19 Preparedness Fund. €11m of that will go to build an AI-based decision support system that allows more rapid and accurate COVID-19 diagnosis and prognosis. Meanwhile, machine learning is being used in a collaboration between Microsoft Corp and Adaptive Biotechnologies to characterise T cell response in thousands of COVID-19 patients. The aim is to find unbiased predictive patterns for severe disease in a representative population.

Still many hurdles to overcome According to Brian Martin, Head of AI at AbbVie, “one of the biggest challenges [to delivering the AI value at operational, analytical, and experimental levels] is breaking down silos.” What he means is that even highly standardised clinical data do not contain the right meta­data to allow the machines to recognise the context in which data were collected. That’s necessary if they are to be re-used for other purposes, helping to lower costs for clinical trials or screening campaigns. An industry survey conducted by the Pistoia Alliance – a non-profit coalition of Big Pharma enterprises trying to solve precompetitive challenges in product de-

European Biotechnology | Summer Edition | Vol. 19 | 2020

velopment – confirms that AI in the life sciences is still being held back by both data issues and skill shortages. More than the half (52%) of all surveyed life-science decision­makers confirmed Martin’s view that the accessibility of data is the biggest barrier in the adoption of AI and machine learning, while 44% cited lack of skills or qualified experts. However, over two-thirds (70%) of the respondants said they’re now using AI. That’s up from 44% in 2017. According to the survey, another challenge to the adoption of AI and value generation is data quality. “Our survey shows the life sciences industry is very interested in adopting AI, but that some issues are still hampering it’s use,” says Nick Lynch, Head of the Pistoia Alliance’s AI Center of Excellence. His team is working to improve data standards and data management.

FAIR data – the way forward? “Basically, the great heterogeneity of data from life sciences labs hampers the digitisation of life sciences data acquisition, access, management and mining,” explains Pistoia Alliance Project Manager Ian Harrow. Backed by both SMEs and large pharma firms like Astra­ Zeneca, Bayer, Roche, Novartis, Bristol­ Myers Squibb, Abb­V ie and Copyright Clearance Center, the Alliance in May launched a freely accessible toolkit to

help companies implement the FAIR data­-guiding principles. These principles were published in 2016 as a blueprint for properly managing machine-actionable data, in order to allow computational systems to find, access, inter­operate and reuse it with minimal human intervention. The drive to make data FAIR comes at a time when the industry is both undergoing significant digitisation and generating enormous data volumes. Companies need guidance in how data should be captured and managed in order to improve R&D and commercial productivity longterm. The toolkit uses cases and methods that demonstrate the utility of FAIR data management. Among them: ›› Bayer AG, for example, has integrated data from collaborations with healthcare professionals to ease identification of best partners for future collaborations, marketing and scientific exchange in certain medical fields. ›› The Hyve is currently making 100 million health records findable and accessible to qualified users. It’s also creating infrastructure for a European Health Data Network for collaboration on real-world healthcare data. ›› Roche is again leading the pack. The Swiss drugmaker has pioneered a system that makes external and internal data fair the moment they enter the company’s cloud (see p. 54). “The toolkit will help to smooth the path to greater data sharing within and between industries, which is critical to future research efforts,” predicts Principal Scientist Dr. Martin Romacker. According to Ian Harrow, AI applications won’t come in a sudden flood, but in a continuous stream as data management improves. “We’re already very good at managing access to personal patient or IP-protected data,” he says addressing concerns in that area. “But the big challenge is to make the data inter­ operable, that is to translate it into a vocabulary and metadata that can be read by different analysis platforms in a way that makes sense.” L t.gabrielczyk@biocom.eu

Picture: Quardia Inc./stock.adobe.com

56


European Biotechnology | Summer Edition | Vol. 19 | 2020

Advertorial

AI-guided precision medicine Artificial Intelligence  Self-learning algorithms can help to read out tumour-specific patterns

Picture: Indivumed Group

from omics data of quality-assured sample materials and clinical patient data. Prof. Dr Hartmut Juhl, founder and CEO of the Indivumed Group, talks about their benefits in personalised cancer medicine.

EuroBiotech_AI-assisted identification of biomarkers and drug targets from quality-assured tissues promises to personalise the treatment of complex diseases associated with multimorbidities, such as cancer. How does Indivumed, with its multi-omics platform IndivuType, contribute to this kind of much needed innovation? Juhl_Cancer is a highly complex disease, triggered and driven by a multitude of cellular malfunctions in malignant degenerate cells and – reactively – in the body’s own healthy cells, such as immune cells. In addition, there are numerous, other individual factors, some of which can be derived from clinical data. Indivumed’s goal is to decipher this complexity for the development of personalised cancer therapies and make it therapeutically useful. With today’s means of artificial intelligence, but also various other data analytical methods, we are able to decipher the variety of information from multiomics data of tumours, together with the individual clinical information. At Indivumed, we are convinced that genetic data (for example, mutations) alone are not sufficient to understand the complexity of cancer and to develop personalised therapies. Rather, it is necessary to include as many tumour biological data points as possible in the analysis. This means that, in addition to the genetic information in tumour tissue, numerous other data points must also be recorded. These include transcriptome and proteome data, but also the activity of signalling pathways (phosphoproteomics) and histomorphological images of the

tumour tissue that reflect the cellular composition of the disease. These must then be correlated with clinical data (medical history, therapeutic measures, survival time, etc.). In addition, additional frozen tissues are available as a “raw data set,” in order to add further biologically relevant data, such as epigenetic or metabolomic data, if required.

Hartmut Juhl, is the Chief Executive Officer of Indivumed Group. The surgical oncologist, who has dedicated himself to the science of tissue quality and its application in precision medicine for cancer diagnosis and therapy, holds an APL professorship in the Medical Faculty at the University of Hamburg, is an Adjunct Professor at the Lombardi CCC of Georgetown University in Washington, DC, and an advisor to the US National Cancer Institute. In 2008, Juhl founded Inostics GmbH, together with scientists from Johns Hopkins University in Baltimore, Maryland and Indivumed GmbH. Inostics GmbH commercialised the jointly developed Liquid Biopsy method for the detection of mutations of solid tumours in blood and was sold to Sysmex Corp. in 2013.

EuroBiotech_What about reproducibility? Juhl_However, in order to be able to measure these comprehensive biological data in a meaningful and comparable way, it is essential that the biological samples, namely the tumour tissue, are not only collected according to strict and uniform standards in each patient, but are also well documented and shock frozen within minutes after surgical removal. Just as a person is brain dead after eight to ten minutes, the tumour tissue also changes rapidly after tumour removal. Studies have shown that various expression data of RNA, proteins, and signalling pathways can no longer be determined in a meaningful way after 10 to 20 minutes. Since Indivumed has been developing the technique of standardised tissue sampling for 18 years and successively optimised for all tumour entities, we are now able to develop our multiomics database IndivuType according to identical standards, together with partner clinics worldwide. This enables us to include ethnic and socio-economic variations in the tumour biological data evaluation. Within a year, we have already been able to access data records of several thousand patients. Our tu-

57


Advertorial

mour-biological acuteness allowed us to identify new therapeutic targets for colorectal cancer within weeks using various algorithms, including AI algorithms, and to develop new potential drugs within months, through a partnership with Evotec. EuroBiotech_What are the advantages and complementarities of Indivumed’s approach, compared to other companies’ offers for personalised cancer diagnostics? Juhl_With IndivuType, we are creating a database that accelerates drug development by finding and validating new therapeutic targets more quickly and reliably. On the other hand, we are building up an international reference database that helps patients to gain a better understanding of their individual tumour biology and, thus, to find the best possible therapy. Thanks to our global presence, with numerous clinics in North and South America, Europe, and Asia,

European Biotechnology | Summer Edition | Vol. 19 | 2020

through which we can collect tumour data from over 100,000 patients annually, this database benefits patients worldwide. It is an exciting and fascinating project that outshines all previous tumour databases, which are essentially based exclusively on genetic data gathered mainly from US patients. EuroBiotech_In mid-April, Indivumed publicly launched the Oncology Alliance for Individualised Medicine (“Onco AIMed”). What is the goal, and how and when do you expect to achieve it? Juhl_Onco AI-Med is a great alliance of clinics that have partnered with us to build the Multi-omics database. These clinics, from the US, Brazil, Germany, Spain, Italy, Sweden, Poland, Singapore, Japan, and Korea, for example, have joined forces not only to fill the database, but also to find ways to make Multi-omics data usable for patients. Through Onco AI-Med, our collaboration not only gives every clinic that pro-

vides tissue according to our quality criteria access to their patients’ respective Multi-omics data but also initiates research projects in which clinicians join forces to answer complex questions that require larger data sets. With Onco AI-Med, we can achieve the goal of this entire data project: to make the knowledge gained available to patients as quickly as possible. Within the next two years, we expect our database and the Multi-omics data sets to be used diagnostically for individualised oncological treatment, and this international collaboration is essential for this care. Contact

Indivumed GmbH Falkenried 88, Bldg. D 20251 Hamburg Tel: +49 (40) 41 33 83 - 0 Fax: +49 (40) 41 33 83 - 14 Press@indivumed.com www.indivumed.com

In April, Indivumed GmbH announced the launch of the Oncology Alliance for Individualized Medicine (Onco AI-Med), an international collaborative alliance to advance personalized medicine in cancer through Indivumed’s true multi-omics database, IndivuType. Onco AI-Med activity is organized around tumor entities, with specific working groups for each one. These groups will explore the best use of the unprecedented data sets available in IndivuType and link them to real world clinical care through specific research projects, coordinated by an Advisory Board that includes some of the brightest thought leaders in oncology.

Pictures: 123rf-co,/ Sebastian Kaulitzki

58


A CDMO with vital expertise in virotherapy manufacturing

P

Y

to c e

c c i n es a V r V

V

O

T

R

A

Vira l

H

s

y

A P Y E R

Ge n e T h

r o t Ve c

p

ral

era

Vi

V I R O T H E

y t ic V i r u l o se nc

s

O

H E R A O T P R Y I V On c o l og y

+49 4721 565 400 www.vibalogics.com

I R


Interview

European Biotechnology | Summer Edition | Vol. 19 | 2020

Paving the way for data analytics Artificial Intelligence  AI in the life sciences is still being held back by data issues and skills

shortage, a survey from The Pistoia Alliance finds. European Biotechnology spoke with Ian Harrow, Consultant at the Alliance, about how to improve life sciences data management with help of a new toolkit that makes data Findable, Accessible, Interoperable, and Reusable – in brief: FAIR.

better data management – something that is more graspable. So, they came up with the FAIR guiding principles for data management and stewardship published in 2016. FAIR data and metadata can be ready at scale by machines ready for analysis. And that’s what feeds artificial intelligence: well manageable and high quality data. That is really the heart of it.

EuroBiotech_This May, the Pistoia Alliance launched the FAIR toolkit (fairtoolkit.pistoiaalliance.org). What is this about? Harrow_In the life sciences we have the

particular problem that the current fast streams of Big data come in all sorts of different varieties because of the many different types of instruments we have there – for instance from molecular biology, biochemistry and chemistry. Basically, this heterogeneity hampers the digitisation of life sciences data acquisition, access, management and mining. So, the particular challenge is to manage all that data so that you can get value from it at scale. As data are often siloed, stored in varying formats, and difficult to retrieve or share, the key is better data management, i.e. to make data Findable, Accessible, Interoperable, and Reusable – in brief: FAIR. In mid-May, the Pistoia Alliance – a nonprofit organisation of life sciences companies which aim to improve R&D product ivit y through pre-competitive collaboration – launched guiding principles for making data FAIRable. The FAIR toolkit will help to smooth the path to an improved data sharing within and between industries, which is critical to future research efforts and realizing the value of technologies like deep learning, advanced analytics, and artificial intelligence. EuroBiotech_How is FAIRability of data linked to the automated data analytics?

EuroBiotech_ Are there differences between research data from academic partnerships and clinical data? Harrow_Fair data management started Ian Harrow, is an independent consultant providing services in project management, bioinformatics and data analytics. He has been an active member of the Pistoia Alliance since its inception ten years ago and he is a project partner for the BioExcel Center for Computational Biomolecular Research. He worked as a senior principal scientist at Pfizer for 27 years. Prior to this, he undertook postdoctoral research in neurobiology at Columbia University following a PhD in neuropharmacology and electrophysiology at the University of Cambridge.

Harrow_The thing that changed in 2014

was a group of academics meeting in Holland realised they really had to make

in research labs and now is coming to the healthcare environment. Management of research data is far more simple compared to healthcare, in a hospital environment. For clinical trials data, there are some very mature clinical standards for managing data. We are talking with those clinical standards organisations to understand how the FAIR toolkit can add value. EuroBiotech_What was the feedback from Pharma and biotech companies? Harrow_ Since we launched the project,

we have had tremendous interest from global pharma as well as SMEs, demonstrating just how important a resource like this is for the entire life science industry. “The FAIR toolkit will enable organisations to realise the value of their data, accomplish effective data management, and build a more collaborative research environment. Data is the con-

Picture: Indivumed Group

60


European Biotechnology | Summer Edition | Vol. 19 | 2020

necting thread between all of our projects at The Pistoia Alliance, underpinning initiatives like the Unified Data Model, as well as the effective application of AI. We’ll continue to work with our members on developing projects that deliver such tangible benefits to their organisations. EuroBiotech_ Are you expecting a big boost in knowledge by using the FAIR toolkit? Harrow_For certain purposes, better –

EuroBiotech_What is the biggest challenge in making data FAIRable? Harrow_We are already very good at

managing access to personal patient or IP-protected data. But the big challenge is to make t he dat a interoperable through different ontologies, i.e. to translate it into a vocabulary and metadata that can be read by different analysis platforms in a way that makes sense. EuroBiotech_For which applications of the FAIR toolkit is there already initial data on the potential benefits? Harrow_ We already have five use cases,

three from Big Pharma and two from technology companies, to demonstrate the benefits of FAIR data management to life sciences companies. One is focussed on COVID-19, coming from The Hyve, a Dutch company, which is devel-

Asier_Relampagoestudio - Freepik.com

not even necessarily perfect – data management can provide very fast answers, particularly when machines can reuse the R&D and clinical data of approved drug candidates. A current use case is finding a drug repurposed for the treatment of COVID-19. FAIR data management allows the rapid re-use of FDAreviewed data packages that could otherwise be overlooked. That’s big progress because these data have been obtained by very costly R&D development and Phase II/III clinical trials. So,

making data FAIR and thereby machinereadable allows companies to make better use of their own data across different therapeutic areas and get extra value.

The shortage of skilled labour is a serious obstacle to growth for businesses in many European countries. At the same time, in many places well-qualified people are looking for a job – they might even want to work in another European country. Unfortunately, the labour markets in Europe are very diverse. How do I find a new job or a new employee? Now, there is an easy solution: eurobiotechjobs.net, the new, Europe-wide job market for biotechnology and the life sciences. Presented by the European Biotechnology Network.

Interview

oping semantic models to build knowledge graphs which means blending novel data coming in from clinical trials on COVID-19 drug candidates with previously published knowledge from the SARS or MERS corona viruses. There is a use case of Roche that has pioneered a platform that handles external and internal data in making data FAIR by design. Another use case comes from Bayer that has built a platform to FAIRify data coming in from partner organisations in order to create more value. A further use case from SciBite, a UK technology company, is enriching the annotation of the metadata in order to define the context in which a measurement was made. That’s important to improve reproducibility and machinereadability of data. It’s just early days in the journey of FAIR data management but we can see from the use cases that improved data management will become best practice in the industry. L t.gabrielczyk@biocom.eu

61


Economy

European Biotechnology | Summer Edition | Vol. 19 | 2020

Vital expertise in oncolytic virus production oncolytic viruses  Oncolytic viruses, viral vectors for gene therapy and viral-vectored

prophylactic vaccines, are new, innovative, and already successful approaches for the treatment of severe diseases. The production of these viruses requires extensive experience and speciallydesigned GMP clean rooms. Vibalogics offers both. › Kai S. Lipinski, CSO, and Stefan Beyer, CEO, Vibalogics GmbH, Cuxhaven, Germany

Oncolytic viruses (OV) have proven to be very effective weapons in the fight against cancer. OVs infect and replicate in tumour cells. They not only primarily lyse infected cancer cells, but usually also exhibit immune-modulating and adjuvant properties, as they present tumour-specific antigens to the immune system or express immunemodulating cytokines. OVs, therefore, offer a number of advantages as compared to other forms of cancer therapy: they act in a targeted manner, transform invisible “cold” tumours into “hot” tumours that are attackable by the immune system, and activate the immune memory to suppress metastases and relapses. A combination with immune-check-point inhibitors further enhances the effect immensely. With the approval of Amgen’s Talimogene laherparepvec (Imlygic) in 2015, more than 100 companies worldwide have turned towards the development of OVs. Pharmaceutical giants such as AbbVie,

Bristol Meyers Squibb, Johnson & Johnson, Boehringer Ingelheim and others, have entered into licensing and development partnerships with OV companies or have acquired such companies altogether. Currently, well over 150 clinical trials are ongoing, with approximately 80% of all OVs in early development.

The challenge of manufacturing OV candidates are derived from a wide variety of virus types such as herpes, adenoviruses, vaccinia, parvo, arena and others. The production systems are as diverse as the viruses themselves: Adherent or suspension growing Vero, HEK293, HeLa S3 and A549 cells as well as chicken fibroblasts are used. The aim is to maintain the infectivity of the viruses after upstream and downstream processing as highly concentrated and active virus solutions are required for clinical trials.

Vibalogics is a fast growing global service provider in the field of live virus production. Processes are developed using suspension bioreactors or fixed bed manufacturing platforms, as well as multi-unit CellStacks and Roller Bottles. Egg-based manufacturing also has a role for certain viruses. After downstream development and process upscaling, aseptic process validation in BSL-2 classified clean rooms is performed if necessary. Analytical methods are developed concurrently to characterize and quantify the virus prior to clinical trial material supply. Bulk material and finished Drug Products of up to 30,000 vials per batch are supplied. Lyophilization is also an option and up to 3,000 vials per batch are possible. Remarkably, now in 2020, clinical test material for SARS-CoV-2 is being produced and supplied: A testament to the speed at which our industry is developing. The capacities at the site in Cuxhaven, Germany, will be further expanded with a 500L Single-Use line and a facility for late stage clinical development and commercial production is being planned in the United States. L

Pictures: Vibalogics GmbH

62


SCIENTIST & LAWYER For more than 80 years we are where you are and we deeply understand your business. From all perspectives and in all aspects. In all technical and legal fields of intellectual property. With an interdisciplinary team of patent and legal professionals. www.boehmert.de


Northern EUROPE

European Biotechnology | Summer Edition | Vol. 19 | 2020

Combining oncology platforms

Cell masters Cell therapy  In mid-June,

Zelluna Immunotherapy AS raised €7.5m to refocus on developing allogeneic Natural Killer (TCR-NK) cells that use T-cell receptors (TCRs) to target solid tumours. “This funding will enable us to develop both Zelluna’s allogenic TCR-NK platform and novel TCR-NK products. The potential benefits of allogeneic products in manufacturing, scalability and immediate patient treatment have been recognized across the industry for some time,” said Namir Hassan, who joined the Oslo-based company as CEO in December 2019. TCRs recognise surface antigens of malignant cells guiding T cells deep into tissues to detect the aberrant cell types. NK cells are the innate immune systems first line of defence. High concentrations of NK cells in tumours are associated with increased patient survival. This March, Zelluna entered a multi-year research programme dubbed “NextGenNK Competence Center” with Dr Evren Alici, Head of the Gene & Cell Therapy group at Stockholm-based Karolinska Institute. The programme aims to develop new therapies against solid tumours that are based on the company’s proprietary technology. Zelluna has the exclusive commercialisation rights for any therapy co-developed within this partnership. In November 2019, the Dutch CDMO and CRO Glycostem Therapeutics BV became Zelluna‘s partner. Zelluna’s most advanced TCR candidate, ZI-H04, targets human telomerase reverse transcriptase (hTERT), which is expressed in many solid tumours. 

Antibodies  With a US$3.9bn licence deal and an expansion of its USbased biomanufacturing capacities, Horsholm-based Genmab A/S is significantly expanding its development and production activities for bispecific DuoBody ® antibodies in the US. In mid-June, Genmab announced a research and licence option agreement with US pharma giant AbbVie Inc to develop up to seven new antibody formats. At the end of May, Genmab had already announced it will be expanding its production capacities for the process development and manufacture of DuoBodies through a strategic collaboration with the CDMO Rentschler Biopharma SE, which acquired a US production site in Milford near Boston last year.

Duobodies and ADCs Under the contract, AbbVie will pay Genmab US$750m upfront plus up to US$3.15bn in potential milestone payments. In addition to co-development of three of Genmab’s early-stage investigational bispecific DuoBody antibodies (epcoritamab/DuoBody ® -CD3xCD20; DuoHexaBody ® -CD37 and DuoBody ® CD3x5T4), which will be developed by Genmab until the end of clinical Phase I, the companies agreed to enter into a discovery research collaboration for developing up to four antibody drug candidates against blood cancers and solid tu-

mours by combining Genmab’s Duobody and Abbvies ADC platform . Genmab’s DuoBody-CD3 technology engages and directs cytotoxic T cells to selectively activate an immune response against malignant cells. AbbVie’s ADC technology allows the selective delivery of a highly toxic payload directly to cancer cells. For epcoritamab, companies will share commercial responsibilities in the US and Japan, with AbbVie being responsible for the global commercialisation. Genmab will receive tiered royalties between 22% and 26% on global sales except for the US and Japan, where the Danish company is responsible for commercialisation. For DuoHexaBody-CD37, DuoBodyCD3x5T4 and any product candidates resulting from the companies’ discovery research collaboration, Genmab and AbbVie will share responsibilities for global development and commercialisation in the US and Japan as well as net-profits on a 50-50 basis. Genmab retains the right to co-commercialise these products, along with AbbVie, outside of the US and Japan. Under the discovery research partnership, AbbVie retains the right to licence candidates safety-tested by Genmab in Phase I trials. If all four antibody drug conjugates developed within the discovery research collaboration enter the market, Genmab is eligible to receive up to US$2bn in option exercise and success-based milestone payments. 

In 2019, Rentschler acquired its Milford production site from Shire.

Pictures: Rentschler Biopharma SE

64


European Biotechnology | Summer Edition | Vol. 19 | 2020

Picture: Pictures:Hansa xxx Biopharma AB

Precision landing Formulation  In the first IPO of a Swedish biotech company at the US Nasdaq for the past 15 years, formulation specialist Calliditas Therapeutics AB raised a whopping €90m. The Nasdaq Stockholm-listed company said it will use the proceeds to finance the ongoing Phase III testing of its formulation of budesonide in patients with the rare inflammatory disease IgA nephropathy.

the study duration from six to approximately three and a half years. In addition, the trial size will decrease from a total of 450 participants to 360, in turn positively affecting overall costs and enrolment time. In 2019, Calliditas entered into a €121m deal with Everest Medicines II Ltd pursuant to which it granted Everest an exclusive licence to develop and com-

The autoimmune disease occurs when clusters of aberrant immunoglobulin A (IgA) antibodies lodge in the kidneys – specifically the glomeruli – causing inflammation and, over time, irreparable damage to the organs. Detection of protein and blood in the urine frequently leads to the diagnosis. According to estimates in an Evaluate Vantage report, up to 40% of those diagnosed by protein in the urine (proteinuria) will eventually progress to end-stage renal disease (ESRD). In the pivotal NefIgArd Phase III trial, Calliditas Therapeutics AB is testing whether Nefecon, a targeted formulation of budesonide, is improving proteinuria in IgAN patients compared to placebo. Nefecon improves the low bioavailability of the active substance budesonide via its concentrated, pulse-like release to the Peyer’s patch region of the lower small intestine, where the disease most likely occurs. In September 2019, Calliditas Therapeutics got the FDA’s acceptance of a change to the NefIgArd trial including a two-year eGFR-based endpoint. It is expected that it will cut

mercialise Nefecon for IgAN in Greater China and Singapore. In other key territories such as Europe, the company intends to commercialise Nefecon through either a broad regional partnership or on a country-by-country basis. For its listing on The Nasdaq Global Select Market through a capital increase, Calliditas Therapeutics set the price of 8,306,770 common shares to US$19.50 per American Depositary Shares (ADS) in the US public offering, with each ADS representing two common shares (4,153,385 ADS). Additionally the company sold 924,000 common shares for SEK89.70 per share (US$ 9.47) in the private placement to institutional investors. After the first day of trading, the stock closed at US$20.19, about 3% higher when issued, and subsequently remained at just over US$19. As a stabilisation measure, the company’s board of directors granted the joint global coordinators – including Citi­bank Group – an over-allotment option, that may be utilised for 30 days from the date of pricing of Calliditas Therapeutics’ American Depositary Shares. L

Northern EUROPE

News Ensuring drug supply Thanks to a loan of €2.1m granted by Business Finland, Faron Pharmaceuticals Oy (Turku) is able to develop a new cell line for producing its recombinant intravenous interferon (IFN) beta-1a, traumakine. The immunosuppressant is currently being tested in two late-stage clinical studies with adaptive design: the WHO’s Solidarity trial for COVID-19 medicines and REMAP-CAP for community-acquired pneumonia. Whithin the Solidarity trail, traumakine is being tested for the treatment of patients with Acute Respiratory Distress Syndrome (ARDS). According to Faron’s CEO, Dr Markku Jalkanen, the company has “a good existing stock of IFN beta-1a, but given the ongoing clinical trials and the potential for an increasing future demand of IFN beta-1a for COVID-19 and other viral infections like influenza, we need to begin upscaling our manufacturing capacity.” ARDS is a major complication in COVID-19 patients with severe disease.

Fight bleedings   In mid-June, Swedish Orphan Biovitrum (Sobi) AB and Genzyme Sanofi announced they will donate up to 500 million units of clotting factors XIII and IX to the WFH Humanitarian Aid Programme. The donation is part the 2014 pledge of Sanofi Genzyme and Sobi, Grifols, CSL Behring, GC Pharma, as well as Roche and Bayer to donate up to 1 million units until 2024 to treat “the more of 75% of people”, who have limited access to haemophilia treatment. According to the WFH, 241 million donated units were administered between 2015 and 2019.

65


SOUTHERN EUROPE

European Biotechnology | Summer Edition | Vol. 19 | 2020

Hope for relapsed lung cancer

COVID hope drug development   Barcelona-

based SOM Biotech SA has found three drug candidates that inhibit the replication of SARS-CoV-2 and could, therefore, be potential therapies for the treatment of COVID-19. The drug candidates are now to be tested in patients as soon as possible: eravacycline is an already approved drug, prexasertib, already in clinical development and cynarine is a natural compound used as a dietary supplement. To validate the compounds in vitro, the drug discovery company applied its artificial intelligence-based screening technology to identify inhibitors of the 3CL proteases of SARS-CoV-2, SARS-CoV and MERSCoV viruses as potential candidates to treat COVID-19. 

Shares offered Financing ­Cassiopea SpA, the Italian pharmaceutical company focused on dermatological conditions, has raised €23.25m in a rights offering at SIX Swiss Exchange. Cassiopea, whose main shareholder is Dublin-based speciality pharmaceutical company Cosmo Pharmaceuticals NV, is offering 750,000 registered shares at €31 each. The proceeds will go towards financing the company’s operations up to the planned approval of clascoterone cream 1% in H2/2020 and the preparation of clascoterone cream 1%’s subsequent launch in the US as well as for general corporate purposes. 

Market approval   PharmaMar’s cancer drug lurbinectedin (Zepzelca) has been approved for the US market for the treatment of metastatic Small Cell Lung Cancer (SCLC). Commercialisation partner Jazz Pharmaceuticals is planning on making the drug commercially available in the U.S. in early July. The drug was approved under the FDA’s Accelerated Approval programme, based on overall response rate and duration of response demonstrated in an open-label, multi-centre, singlearm study in 105 adult platinum-sensitive and platinum-resistant patients with relapsed SCLC. Lurbinectedin is an analogue of the marine compound ET-736 isolated from the sea squirt Ecteinascidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is the first new drug ap-

proved for second-line treatment of relapsed SCLC since 1996. “For decades, effective therapies after initial treatment were nonexistent for people diagnosed with small cell lung cancer,” said Jennifer C. King, CSO of GO2 Foundation for Lung Cancer. “We [...] welcome new options to treat this devastating disease.” PharmaMar President José María Fernández added: “The U.S. FDA accelerated approval of lurbinectedin underscores its potential to fill an unmet need in the SCLC community.” As stipulated in the exclusive license agreement signed with Jazz Pharmaceuticals in December of last year, PharmaMar will receive a payment of US$100m as well as royalties based on lurbinectedin’s net sales up to a maximum of 30 percent. L

Lung cancer metastatis

Colon tumour control tumourigenesis   Greek and US researchers studying the contribution of the mesenchymal niche on mutant stem cell dominance and intestinal tumourigenesis have provided the first definitive in vivo evidence that the mesenchymal microenvironment of intestinal stem cells controls the tumour initiation in the colon. The collaborative study was published in Nature (DOI 10.1038/s41586020-2166-3) by scientists at BSRC Flem-

ing and University of Athens Medical School. It reveals a mechanism whereby a population of cyclooxygenase-2 (Cox2)-expressing fibroblasts acts through the prostaglandin E2 (PGE2)/Ptger4/Yap signalling axis to exert a paracrine control over tumour initiating stem cells, thus driving colon tumourigenesis in the presence of oncogenic mutations. The scientists hope that the pathway revealed in the study could provide alternative therapeutic targets for colorectal cancer. L

Picture: National Cancer Institute / Winship Cancer Institute of Emory University - Creator: Scott Wilkinson, Adam Marcus

66


Flexibility.

Adaption to our clients’ needs. Offering customized solutions is one of our core values that governs our daily work. Being highly flexible we have extended our lab expertise to meet current customer demands in clinical trials. • Flow Cytometry • PBMC isolation • RT-PCR • Extended single and multiplex assay capacity

MLM Medical Labs is one of the leading central labs for clinical trials in Europe. For over 25 years we have been supporting clinical studies phase I-IV with full laboratory services, kit building and logistics. For further information please contact Dr. Katja Neuer at kneuer@mlm-labs.com or visit us at mlm-labs.com.

MLM Medical Labs GmbH Dohrweg 63 41066 Mönchengladbach Germany


Centr al EUROPE

European Biotechnology | Summer Edition | Vol. 19 | 2020

New records for biopharma

SBD cancelled Swiss Biotech Day  Probably the

most important life science conference in Switzerland this year has finally been cancelled. At the beginning of July, the Swiss Biotech Association (SBA) made the difficult decision to call off the Swiss Biotech Day 2020 for good due to the threat of the coronavirus pandemic. The Association’s General Assembly is to be held digitally on 15th September. The next Swiss Biotech Day is scheduled to take place in Basel on April 20, 2021. 

Markets  Biopharmaceuticals set new records in the German pharmaceutical market in 2019: sales of €12.7bn (2018: 11.2bn), market share of 29% (2018: 27%). The number of people employed in biopharmaceutical companies grew by 6% to 42,300, according to the biotechnologists from vfa.bio (Association of Research-Based Pharmaceutical Producers) in their new industry report “Medical Biotechnology in Germany 2020”. “Biopharmaceuticals are economically successful because they meet a medical need. Germany as a location plays an important role, both in development and production,” said Frank Mathias, Chairman of vfa.bio and CEO of Rentschler Biopharma SE. “We can play out strengths in technology and qualification here compared to countries with lower wage levels!” In 2019, sales of biosimilars exceeded the billion mark (€1.5bn) for the first time – a more than 60% increase compared to the previous year. In competition with their

reference original products, they achieved market shares of up to 60%. According to vfa.bio, this shows that biosimilars have become the relevant market factor by their own efforts and do not require any political support measures. However, the originator drugs manufacturers are also still represented in the supply chain with their products because they make competitive offers to health insurance. The current report deals in greater detail the fields of gene, cell and tissue therapeutics, collectively referred to as Advanced Therapy Medicinal Products (ATMP). This product segment is still small, with currently ten approved drugs. However, more than 1,000 studies for additional ATMPs are currently being conducted worldwide. Around 47% of these studies are being conducted in the USA, with China in second place with 39%. In Germany, only 4.4% of ATMP studies are carried out. The vfa.bio has developed concrete proposals to improve this. 

Bioeconomy Germany has its own ship to bring current scientific trends to the interested public. The MS Wissenschaft (MS Science) is a 100-metre-long inland motor vessel that tours Germany and Austria each summer with changing exhibitions. This year, the focus is on the bioeconomy. Uunfortunately, this important event was torpedoed by the coronavirus pandemic. Instead of starting in spring, the ship will now open in Münster on 30th July and later head southwards on the Rhine. The destinations in the north and east will follow next year. A reporter from European Biotechnology sighted the ship in Cologne at the beginning of July.  

Picture: mswissenschaft/bmbf

68


European Biotechnology | Summer Edition | Vol. 19 | 2020

Biontech attracts Singapore investment The Nasdaq-listed German biotech company Biontech SE, focused on patient-specific immunotherapies for the treatment of cancer and infectious diseases, published a private investment of €223m by Singapore’s sovereign wealth fund, Temasek, and other accredited investors. The private placement includes an investment of approximately €124m in ordinary shares and a €100m investment in 4-year mandatory convertible notes. “We are pleased to welcome Temasek onboard as a new shareholder. We believe

their long-term investment approach, global presence, and deep experience in the biotechnology field are a good fit with our vision to build a leading global biopharmaceutical company,” said Ugur Sahin, CEO and Co-founder of Biontech. Later, Pfizer and Biontech announced preliminary U.S. data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic. 

Immatics is now being traded Stock Exchange  The days when biotechnology companies took the effort of an IPO seem to be long gone, this is particularly true for Germany, whose capital markets seems to have lost all biotech expertise and thus attractiveness. The most recent example is the Tübingenbased company Immatics, a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies. In early July, Immatics announced the completion of its business combination with Arya Sciences Acquisition Corp. (NASDAQ: ARYA), a special purpose acquisition company (SPAC) sponsored by Perceptive Advisors. Only one day later, Immatics NV commenced trading its shares under the symbol “IMTX” and its warrants under the symbol “IMTXW” on the Nasdaq Capital Market. Proceeds from this transaction included funds held in Arya’s trust account and the common stock private investment in public equity (PIPE) financing, contributed by a group of leading US healthcare institutional investors. The shareholders of Arya only approved the transaction on June 29, 2020. The transaction had been previously approved by Immatics shareholders. Immatics’ management team, led by Chief Executive Officer Harpreet Singh, PhD, will continue to run the combined company.

New investors supporting the transaction include Perceptive Advisors, Redmile Group, Federated Hermes Kaufmann Funds, RTW Investments and Sphera Funds, alongside existing Immatics investors dievini Hopp BioTech, AT Impf (Strüngmann Brothers) and Wellington Partners. CEO and Co-Founder Harpreet Singh said: “This transaction will provide us runway and flexibility for our pursuit of unlocking new therapeutic options for cancer patients by advancing our clinical and pre-clinical programmes for adoptive cell therapies and TCR bispecifics. Our programmes are directed against a range of targets that address multiple rare as well as common cancers that have been hard to treat.” As a result of the business combination, Immatics received proceeds of approximately $253m, prior to transaction expenses, which includes cash proceeds of approximately $149m from Arya’s trust account and $104m from PIPE investors led by Perceptive Advisors, other toptier US healthcare investors and existing Immatics investors. The stock exchanges seem to have great confidence in the German company that employs a total of around 200 people in Tübingen, Munich and Houston. In the first few days, the share price rose from almost €14 to almost €21 and then fell to €12.50, which represents a market capitalisation of €782m. L

Centr al EUROPE

News Tests on virus samples In the BSL-3 laboratory at the Medical University of Graz, the laboratory with the highest safety equipment in Austria, possible drugs are currently tested for their effect against the SARS-CoV-2 pathogen in cell culture experiments. In this interdisciplinary research project, the Austrian Centre of Industrial Biotechnology (acib), the Medical University of Graz and the Graz-based biotech company Innophore GmbH have set themselves the goal of establishing a preclinical drug database. The aim is to bring antiviral drugs much faster to clinical application. Additional therapeutics are also being developed for already infected COVID-19 patients.

US success for Paion  The U.S. Food and Drug Administration (FDA) has approved Remimazolam developed by the German Paion AG for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. This is a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy. Paion has developed the drug with the trade name BYFAVO ® including the conduct of three Phase III clinical studies and granted Cosmo Pharmaceuticals N.V. exclusive rights to develop and commercialise it for the U.S. market in 2016. Under the terms of the agreement with Cosmo, Paion will receive a milestone payment of €15m from Cosmo and is entitled to tiered royalties on net sales in the U.S. ranging from 20% to 25%. Paion’s share price briefly gained more than 30%.

69


WESTERN EUROPE

European Biotechnology | Summer Edition | Vol. 19 | 2020

Citizens alone at home

Beam me up COVID-19  After the chimpanzee

adenoviral COVID-19 vaccine ChAdOx1 nCoV-19 – developed at the University of Oxford by Sarah Gilbert and Andrew Pollard and produced by Halix BV – successfully passed Phase I safety testing, AstraZeneca plc acquired the worldwide marketing rights. In Phase II/III trials, which started enrolment of up to 10,260 volunteers at the end of May, the immunogenicity and in vitro virus neutralisation capability of the jab, renamed AZD-1222, and the MenACWY ‘control’ vaccine is now to be compared. In June, Lyon-based vaccine and gene therapy vector CDMO Novasep SA announced that it will contribute to the production for up to 300 million doses of AZ1222 ordered by the Inclusive Alliance for Vaccines (IAV), consisting of France, Germany, Italy and the Netherlands. But the Alliance will also make AZD-1222 available for other countries in Europe starting from autumn. In its Seneffe (Belgium) facilities, the CDMO will produce the active substance of the vaccine, while Emergent Bio­s olution Inc will be AstraZeneca’s manufacturing partner in the US. There, AZ-1222 was selected for a €1.2bn funding within US President Donald Trump’s COVID vaccine accelerator “Operation Warp Speed” that is aimed to provide 400 million doses until September 2020. Through an EU emergency fund of €2.3bn, the European Commission has the mandate to purchase up to six different COVID-19 vaccines for all member states. L

Antibody testing An international research consortium has found initial evidence that SARS-CoV-2 antibody tests are only useful for population-based analyses. This is no good message for policymakers willing to relax social distancing measures based on immunity passports or antibody titers against the spike- and nucleocapsid proteins of SARS-CoV-2: In Science Immunology, Juliet Bryant from Fondation Mérieux in Lyon, France, and colleagues highlight the potential power of population-level serological, or antibody testing to provide snapshots of infection history and immunity in populations as the COVID-19 pandemic progresses. In contrast, they emphasise the risks of using current serological tests to assess individual immunity to the SARS-CoV-2 virus. While the World Health Organization WHO recommends restricting such antibody testing to research use only, scientists here argue that these tests – even with moderate sensitivity and specificity

levels – could provide highly valuable information to address critical public health questions, such as when to relax stay-athome orders or school closures. In theory, antibody tests can examine whether or not a person has ever been exposed to a certain virus. However, what SARS-CoV-2 antibody test results mean for protection and immunity is still poorly understood. Thus, as tools to issue “immune passports” that certify an individual’s immunity, current serological tests were insufficient and even harmful, the authors write; the tests would, in fact, need near-perfect specificity to provide a reliable gauge of immune protection. By contrast, as tools to ascertain populationlevel epidemiological trends, and in conjunction with PCR testing, serological surveys could help officials estimate the risk of future waves of disease, measure the impact of interventions, and may provide a less biased picture of infection fatality rate than PCR testing of viral RNA. L

Evox Therapeutics has isolated and analysed exosomes targeting different tissues.

Struggling for market shares OncoLogy Dutch formulation specialist SeraNovo BV has extended the exist-

ing licence contract with US kinase blocker expert Carna Biosciences, Inc. Under a new contract, the companies will co-develop an oral GRAS excipient-based formulation to increase the oral bioavailability of a preclinical pipeline product of Carna BioSciences. L

Picture: SeraNova BV

70


European Biotechnology | Summer Edition | Vol. 19 | 2020

New vesicular vehicle

WESTERN EUROPE

News Bone growth

Drug delivery Evox Therapeutics Ltd has licenced its exosome-based RNAi/antisense RNA delivery technology to Eli Lilly to target selected brain/ CNS disorders. Lilly paid US$20m upfront and US$10m per convertible bond. Additionally, Evox Therapeutics is eliglible to receive up to US$1.2bn in development, regulatory and commercial milestone payments. Under the contract, Eli Lilly will provide antisense oligonucleotides directed against five, not speci-

fied yet, neurological drug targets. Evox Therapeutics will functionalise exosomes in order to achieve brain/CNS targeting, drug loading and analytics and some in vitro assay development, as well as material supply for initial in vivo studies. Lilly will have the right to opt in after preclinical proof of concept and will receive the exclusive right to commercialise all licenced drug candidates. Evox will receive tiered royalties on net sales if a product makes it to the market. L

Picture: Evox Therapeutics Ltd

Money for CBD developers Finance In June Óskare Capital SAS launched the first European fund particularly dedicated to EU companies in the medical cannabinoid industry: Óskare Fund I targets next-generation cannabinoid therapies and related industry infrastructure, leveraging the expertise and track record of the founding team in medicine, engineering, chemistry, venture capital, and intellectual property. “I am convinced that Europe has the optimal regulatory and research environment to build the future key players in the global medical cannabinoid industry,” said Bruce Linton, co-founder and non-executive Chairman of Óskare Capital SAS and former CEO and founder at Canopy Growth. The fund will invest in a di-

versified portfolio of companies with disruptive technology and strong barriers to entry. The team is supported by a highly experienced senior advisory board that provides critical expertise and expands its network. Medical grade cannabinoidbased products are already approved and used in Europe to treat conditions such as epilepsy, multiple sclerosis and chronic pain. Now the science and the medical community are driving opportunities in human as well as animal health and wellness. The fund will invest in the entire value chain as well as look to valorise hemp and cannabis biomass for new sustainable material applications. A first investment has been made in Denmark’s Octarine Bio. L

Belgian Bone Therapeutics SA has secured €11m to foster the development of its late-stage pipeline candidates. The company said it will use the proceeds to advance two key assets of its allogeneic cell therapy platform, ALLOB and JTA-004, which have both completed Phase IIa tests. The financing operation consists of a €4.75m bridge loan, €1.26m in equity private placement by existing shareholders and, on an as-needed basis, a €4.99m private placement of convertible bonds. Subject to the completion of the current financing operation, supporting the company’s further development and strengthen its balance sheet, Bone Therapeutics expects to have a runway into Q1/2021.

Adding compounds For years, French Carbios SAS has worked to set up a process that effectively depolymerises polyethylen­ terephtalate (PET) waste, which makes one-fifth of the 359 million tons of mostly non-degradable plastics produced annually. In April, details of the process were published. While mechanical properties are lost during the physico-mechanical approaches applied today to degrade PET, Carbios’ optimised bacterial hydrolase/depolymerase leads to over 90% of PET recovery by a process that lasts 10 hours and is to be scaled up by 2021. The company’s process provides recycled PET that exhibits the same properties as petrochemical PET and can be produced from enzymatically depolymerized PET waste, thereby contributing towards the concept of a circular PET economy.

71


EASTERN EUROPE

European Biotechnology | Summer Edition | Vol. 19 | 2020

Cancer cleavage

Hot target Deal  Galapagos NV and Selvita’s

2019 oncology drug development spinout Ryvu Therapeutics SA (Warsaw), will collaborate under a licence option agreement to find new small molecule drugs for the treatment of inflammatory diseases. The collaboration is based on a novel drug target identified by Ryvu Therapeutics, which will contribute to the partnership with its technology platform and which is willing to licence related intellectual property (IP) to Galapagos. Ryvu and Galapagos will both provide resources to support the collaboration and make use of their expertise in high-throughput screening, biology, medicinal chemistry, and toxicology. Under the agreement, Ryvu will be responsible for early drug discovery. Galapagos can exclusively opt-in to licence and take over development of this programme. The companies did not publish any financial details of their deal, such as the amounts of the upfront payment or of option, milestone, and royalty payments. Ryvu Therapeutics has pipeline candidates targeting kinases, synthetic lethality, as well as immuno-oncological and cancer metabolism targets. Ryvus lead candidate SEL120 is a selective CDK8 kinase inhibitor with potential for the treatment of haematological malignancies and solid tumours currently in Phase I clinical development for the treatment of acute myeloid and myelodysplastic syndrome. SEL24/ MEN1703 is a dual PIM/FLT3 kinase inhibitor licenced to the Menarini Group in clinical development for the treatment of acute myeloid leukemia. L

Cancer   PPF Group-owned immuno-oncology specialists Sotio AS (Prague) and Cytune Pharma SAS (Nantes) presented preclinical data on their IL-15 receptor-b/g superagonist SOC101 (RLI-15) at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II (22-24 June 2020. SO-C101 (RLI-15, Cyp 0150) is a human fusion protein of IL-15 and the high-affinity binding (“sushi”) domain of IL-15Ra. When given alone, the protein drug candidate, which is currently being Phase I safety tested by Cytune Pharma, decreased tumour growth in both, a lung cancer (TC1 mice) and prostate cancer model (TRAMP C2 mice), by pro-

moting NK-and CD8+ T-cell proliferation and concurrent inhibition of immunedampening regulatory T cells. According to the companies, SO-C101 prevented tumour development “in the majority of mice” when co-administered with the PD-1 blocker pembrolizumab (Merck & Co./Merck Sharp & Dohme). “We look forward to completing the monotherapy arm of our Phase I/Ib dosefinding study in advanced solid tumours before the end of the year and initiating the dose escalation in combination with pembrolizumab in summer 2020,” announced Radek Špíšek, Chief Executive Officer of Sotio, the sponsor of the study. L

In cynomolgus monkeys, various schedules of administration of RLI-15 showed a dose-dependent expansion of peripheral blood lymphocytes, predominantly of NK cell and memory T killer cells.

Finding the best candidates Repurposing  Researchers at Universities of Trondheim, Norway and Tartu (Estonia) have developed a virus neutralisation assay using SARS-CoV-2 strain and Vero-E6 cells. The assay allowed them to identify the most potent sera from recovered patients for the treatment of SARS-CoV-2-infected patients (Viruses. doi: 10.3390/v12060642). The research team led by Svein Arne Nordbø and Denis Kainov also screened 136 broad-spectrum antivirals, which had already passed safety testing against

the SARS-CoV-2 infection in Vero-E6 cells. Most effective candidate drugs comprised the HIV protease blocker nelfinavir (Hoffman La-Roche AG), the veterinary poliketide antibiotic salinomycin, the malaria medicine amodiaquine, the cancer drug obatoclax, the alkaloids emetine and homoharringtonine. They found that a combination of orally available virus-directed nelfinavir and host-directed amodiaquine exhibited the highest synergy. L

Picture: SOtio AS

72


Science & Technology

European Biotechnology | Summer Edition| Vol. 19 | 2020

Cell-based vaccination vs mortality-reducing therapies COVID-19  Immunovative Therapies Ltd and its US subsidiary Mirror Biologics Inc. are testing

a novel, T cell-based vaccination concept that might protect risk groups from new SARS-CoV-2 variants and any emerging viral pandemic in the future. However, therapies that significantly reduce the mortality rate of COVID-19 patients may be a cheaper way compared to vaccines to protect high-risk groups. UK researchers reported on the first therapy in mid-June.

In contrast to classical vaccine approaches, Immunovative’s “allo-priming strategy” addresses the phenomenon of viral evolution. In mid-May, for the first time, the company’s CEO Michael Har-Noy and colleagues presented a technology that might provide a universal anti-viral vaccine designed to protect immunocompromised humans and elderly adults from the current SARS-CoV-2 pandemic but also from any future novel virus outbreaks. The vaccination concept appears more convincing than current vaccination approaches, which “will last only for one year,” according to AstraZeneca’s CEO Pascal Soriot. Patients will receive a series of injections of bioengineered Th1cells, which are thought to remodel the ageing immune system to reverse immunosenescence and protect against chronic inflammation. According to CEO HarNoy a Phase I/II clinical protocol for testing the concept in 40 healthy adults

over 65 years was cleared by the US FDA at the end of June and and enrolment will start by August. “We will be collecting blood from the elderly volunteers and challenging the blood with a panel of live viruses to determine if the remodelled immune system can suppress the propagation of SARS-CoV2 and influenza A and B viruses cultured on human lung endothelial cells,” Har-Noy told European Biotechnology. “We are currently seeking partners for EU and China and South-east Asia”.

Preclinical success According to Immunovative Therapies Ltd, allo-priming, which triggers cell-based immunity, provides a back-up in case vaccination strategies designed to elicit neutralising antibody protection fail to protect the vulnerable elderly population. Allopriming is performed using activated, in-

tentionally mismatched, ex vivo differentiated and expanded living Th1-like cells (AlloStim®) derived from healthy donors. Preclinically, multiple intradermal injections of AlloStim® created a dominant titer of allo-specific Th1/CD8-T-cytotoxic memory cells in circulation, replacing the dominance of exhausted memory cells of the aged immune system. Upon viral encounter, bystander activation of the allo-specific memory cells caused an immediate release of interferon gamma (IFN-g), stopping viral transcription and leading to bystander activation of innate, cellular effector cells and activation of cross-reactive, allo-specific, CD8-T-cytotoxic lymphocytes (T killer cells). Mainstream vaccination approaches have not been very successful in protecting against emergent viruses, such as HIV, hepatitis C, Zika, dengue, and the pandemic SARS and MERS coronaviruses, which mutate and adapt very rapidly to their hosts.

Feeble vaccination

Lung tissue colonised with SARS-CoV-2

In contrast to childhood diseases, these vaccines will not provide lifelong protection, because they are based on an approach that ignores viral evolution, which makes sense for pathogens such as measles or other childhood diseases. For this reason, current vaccine technology platforms may not produce a timely, protective vaccine against COVID-19 and could result in a vaccine that becomes obsolete after a viral mutation. This would present

Picture: NIAID

74


Next Generation Pharma Partnering The Marketplace Leadin g

in Pha

rma Pa

rtnerin

g Since

25 Yea

rs 74 Athens

The new Marketplaces for Pharma Business Opportunities An unprecedented degree of flexibility: Two days of faceto-face meetings at the physical event plus four weeks for scheduling post-event video meetings. Change from “physical” to “video” anytime. Create and control your own flexible Video Meetings Programme through one single tool in your RauCon User Accounts: any number of pre-arranged follow-up, additional, or stand-alone meetings. Make use of the pharma business opportunities presented even months after the meetings event and the video period are closed.

Athens (Greece) Event: 23 + 24 November 2020 Hotel Grande Bretagne, Athens, Greece Video Meetings Period: 25 November - 23 December 2020

1 Singapore Singapore Event: 25 + 26 January 2021 Swissôtel The Stamford, Singapore Video Meetings Period: 27 January - 25 February 2021

75 Lisbon Cascais (Portugal) Event: 15 + 16 March 2021 Hotel Cascais Miragem, Cascais, Portugal Video Meetings Period: 17 March - 15 April 2021

Register now for euroPLX or asiaPLX on www.raucon.com. The Original since 1995. Often copied. Never equaled.


76

Science & Technology

a good business opportunity for vaccine makers but a lottery game for high-risk groups. Another point that is currently widely ignored: traditional vaccines could make rapidly mutating and adapting pathogens more aggressive. Under normal conditions, viral pathogens never become extremely deadly, because they can only spread effectively if most of their hosts survive the infection and are not protected by widespread or herd immunity in the target population.

Dangers and hopes As vaccines create a selection advantage for viruses, which could enter and reproduce themselves ultra-rapidly in the host cell, they might trigger a kind of vaccine-driven evolution, eventually making viruses more deadly and devastating – as postulated for vaccine against Marek’s disease vaccines, a neoplastic disease of poultry. Michael Har-Noy said in a press release: “While there is great optimism regarding current clinical trials investigating protective vaccines against COVID-19, there is a very real possibility that none of the vaccine candidates under investigation will prove to provide long-term protection from COVID-19, and some vaccine candidates may even make symptoms worse. Even in the event that an effective vaccine is timely developed, such a vaccine likely would not be as effective in providing protective immunity in the elderly. If allo-priming is proven to work as designed, a single series of shots could protect against the current pandemic as well as any future pandemic.”

Picture: Immunovative THerapeutics Ltd

Cheap protection for risk groups In mid-June, a faster and cheaper way to protect those who are at the highest risk to develop the life-threatening host immune response following the blood infection with SARS-CoV-2 was reported by researchers from the University of Oxford (UK). Within the systematic RECOVERY study designed to test the efficacy of drugs approved in other indications, they identified dexamethasone

European Biotechnology | Summer Edition | Vol. 19 | 2020

Immunovative researchers in the cleanroom.

as the first drug that reduced COVID-19 mortality in ventilated patients.

A first step but no breakthrough News reports immediately claimed the corticoid drug dexamethasone to be a breakthrough in the fight against SARSCoV-2. However, more effective drugs or combinations therapies might improve the likelihood of rescuing a higher percentage of ventilated patients. According to Principal Investigator Peter Horby from the University of Oxford, the cheap immuno-modulatory drug dexamethasone helped reducing mortality by about one third in ventilated COVID-19 patients compared to the current standard of care. That means that one death could be prevented by this treatment out of around eight ventilated patients. The clinical trial – in which 2,104 COVID-19 hospitalised patients received dexamethasone for 10 days vs 4,321 patients receiving standard-of-care treatment – was part of the UK’s RECOVERY (Randomised Evaluation of COVid-19 thERapY) study that systematically combines potential COVID treatments and compares them with the current standard of care. Similar systematic studies are currently being conducted in the US and Europe. What sounded good at first sight: dexa­ methasone, a DMARD (Disease Modifying Anti-Rheumatic Drug) reduced deaths by one-third in ventilated COVID-19 patients and by about one fifth in other patients receiving oxygen only. There was no benefit among those patients who did not require respiratory support. Dexamethasone is the first treatment that dem-

onstrates a survival benefit for patients in severe WHO disease stages 5 to 7. For comparison: the hyped antiviral drug remdesivir (Gilead Sciences) only helped patients with moderate symptoms but did not demonstrate any significant survival benefit (mortality rate of 7.1% vs 11.9% for placebo) in a Phase II study. The discovery of a treatment that is widely available at a cost of only €16 per 10-day trial per patient may end protectionism of richest Western countries that tried to secure potential COVID-19 jabs to vaccinate their citizens. US President Donald Trump initiated this tragic chapter in health policy with a project called “Operation Warp Speed,” which is funded by the US agency BARDA and intended to give the US access to COVID-19 vaccination. Germany, Italy, the Netherlands, and France followed suit in midJune, securing 300 million doses of an adenoviral vector vaccine licenced from the University of Oxford by AstraZeneca.

High production capacity Even in the case of dexamethasone, the UK government stockpiled 200,000 doses of the drug. But, the good news is that enough of the corticosteroid is available on the world market to treat all those, who need mechanical ventilation – about 5% of people diagnosed with SARS-CoV-2 develop severe disease symptoms. Currently, about 50% of them die. Last year, China produced 32.354 tons of the drug just in Q4/2019, sufficient for 500,000 10-day treatments. “These preliminary results from the RECOVERY trial are very clear,” said Martin Landray, another investigator, “dexamethasone reduces the risk of death among patients with severe respiratory complications. COVID-19 is a global disease; it is fantastic that the first treatment demonstrated to reduce mortality is one that is instantly available and affordable worldwide.” No other therapy has shown a recovery benefit until now. Still, as the drug is an immunosuppressant, it can eventually promote opportunistic infections. L  t.gabrielczyk@biocom.eu


associations

European Biotechnology | Summer Edition | Vol. 19 | 2020

Biotech vision Italian economy Italian biotechnol-

ogy association Assobiotec-Federchimica is carrying out the project titled “Biotech, the bright future - For our health, for our environment, for Italy”. The project was set up to outline operational proposals for the growth and development of the biotech sector in Italy and for the restart of the nation. The project, supported by media company StartupItalia, was officially kicked off in June. A manifesto that outlines the shared action plan for the development of the biotech sector in Italy will be presented at a final event in November. Moreover, the project will involve dissemination activities for the general public. Various initiatives, both live and on social platforms, are aimed at broadening the public awareness of the potential of the bio-based technologies. 

White paper

European Biotechnology is published in co-operation with the following organisations: European Biotechnology NET WORK

Europe: european-biotechnology.net

Europe: medtecheurope.org

Austria: lifescienceaustria.at

Spain: asebio.com

Switzerland: swissbiotech.org

Companion Diagnostics  EFPIA has

teamed up with Medtech Europe to produce a white paper on the assessment of companion diagnostics under the in-vitro diagnostic regulation. Regulation 2017/746 came into force in Europe in 2017 with a transition period of five years. It makes the first European regulatory link between approval of the medicine and the companion diagnostic. Under the regulation companion diagnostics are classified as Class C devices, for (the second highest risk level) and the corresponding conformity assessment will necessitate interaction with both a Notified Body and the European Medicines Agency/National Competent Authorities. In the white paper, EFPIA and MedTech Europe set out several key areas of uncertainty relating to companion diagnostics and the associated medicinal product in the IVDR. The white paper also lays out specific proposals for each area of uncertainty.  Download the white paper: bit.ly/2YpImem

Europe: medicinesforeurope.com

Ireland: ibec.ie/ibia

Denmark: danskbiotek.dk

The Netherlands: hollandbio.nl

Germany: biodeutschland.org

Portugal: www.p-bio.org

UK: biopartner.co.uk

France: france-biotech.org

Council of European BioRegions

CMYK

Italy: assobiotec.it

Sweden: swedenbio.com

Hungary: hungarianbiotech.org

Europe: cebr.net

Europe: ebe-biopharma.org

Norway: biotekforum.no

Finland: finbio.net

Belgium: bio.be

Blue: 100/15/0/35 Orange: 0/75/90/0

European Biotechnology covers the biotechnology sector of the current 27 EU member states, Norway, Switzerland, and UK. If you would like to subscribe, please refer to european-biotechnology.com.

EBE

White Paper on Personalised

77


associations

ternationally less savvy) find a comprehensive partner which is helping to put them in the public window. The participating Life Science Regions are important internal carriers of the dynamics in the Biotech sector, thus enhancing the common understanding of the industry. This and more knowledge is brought European into Europa Bio, the European Biotech Association, where the SBA is an active member.

Switzerland at the forefront of COVID

Domenico Alexakis is Executive Director of the Swiss Biotech Association.

COVID-19  Switzerland is one of the most active countries in the response

to the Covid-19 pandemic. It uses all elements of its life science innovation power. As the country is small and has very limited natural resources, science and knowledge based skills and industries have always been essential.

In the fight against Covid-19 Swiss biotechs and multinational pharma companies like Roche and Novartis are equally involved as universities and university hospitals are. They rapidly launched clinical trials for repurposing marketed drugs to treat Covid-19. Roche was one of the leaders in the development and global distribution of test kits. Swiss scientists were among the first to produce virus clones and to share their knowledge of the virus globally. Manufacturers supported R&D efforts to eliminate constraints in the global supply chain. In this crisis, the international scientific network and good political relations helped Switzerland to not only play an important part in response to the pandemic but to do so in collaboration with international partners that were able to amplify and complement the Swiss response. Swiss companies engaged in

Covid-19 R&D projects could rapidly count on global partners to secure a global supply chain network that will be able to ensure a rapid delivery, once a first vaccine or therapeutic is approved. Remarkably, Swiss biotech companies could easily reach out to their partner network. The access to regulatory bodies internationally was smooth and in many instances accelerated.

Risking diminishing innovation power While the media and the population are much more interested in the development of biotech companies, their technologies, procedures and critical success factors due to the pandemic, R&D biotech companies risk being diminished in their innovative power. In Switzerland and Europe they face at least 6-12

...is an alliance of four leading Biotech regions of Switzerland (Bio Alps, BioPolo Ticino, Basel Area and Greater Zurich Area). They have combined efforts to streamline interests of the national biotech | Summer | Vol. Biotechnology Edition 19 | 2020 sector. The SWX Swiss Exchange holds a leading position in terms of lifescience listings and offers companies from that industry – be they located in Switzerland or abroad – access to an internationally recognised financial marketplace. The initiative was co-founded by the SBA which also manages the executive office of Swiss Biotech.

Logo des Verbands

@

Upcoming Forevents further information please visit www.swissbiotechassociation.ch www.swissbiotech.org

›2  0 April 2021, Basel Swiss Biotech Day 2021 swissbiotechday.ch

months delays in their R&D projects. Academic partners are “locked-down”, many CROs struggle to keep timelines or provide full service, and most importantly, clinical trials are heavily affected. Generally, it has become difficult to start clinical trials and ongoing trials have been either slowed down or were stopped altogether. Equally, biotechs find it hard to cut their fixed costs. They might have to lay off highly talented people, cut their R&D spending and suppress innovative projects, or they are forced to sell IP, licences or even the company at poor financial conditions. This will ultimately weaken the innovation power of Europe, and it is essential to grant emergency loans to biotechs, as well as to support public/private partnerships. Also, it is of utmost importance to establish an overview of all Covid-19 R&D projects to ensure that the most promising are not delayed due to lack of capital. L

Swiss biotechs working on Covid-19 solutions: ›› Alpha-O Peptides ›› Biognosys ›› Ender Diagnostics ›› Humabs Biomed/VIR Biotechnology ›› InnoMedica ›› InSphero ›› LimmaTech Biologics ›› Memo Therapeutics ›› Molecular Partners ›› Neurimmune ›› Quotient ›› Saiba Biotech/University Hospital Berne

Picture: PixxlTeufel/Pixabay

78

Leading chemical companies are exploring the opportunities that have been opened up by modern biotechnology, especially in the field of “white” or industrial biotechnology. And they are also applying these technologies, wherever it makes sense. The SBA takes such initiatives seriously and has formed a working group specifically dedicated to white biotechnology. The Swiss Industrial Biocatalysis Consortium is an important partner in this effort. The group includes leading multinational companies that support white biotechnology as a pillar of economic growth. The planned activities are in agreement with OECD strategies. In partnership with the Swiss Biotechnet (see pages 14/15) the SBA develops training programmes and useful support tools for the industry. It is of importance that the industry specifies its training needs so that the academic side can create tailor-made education. This strategy ensures that the industry gets the right workforce with the right education. The SBA profits from the marketing alliance “Swiss Biotech” (see box) in a multiplied form. Thanks to Swiss Biotech, the


European Biotechnology | Summer Edition | Vol. 19 | 2020

Go 3D with BIOFLOAT

BioProfile FLEX2

3D Cell Culture  BIOFLOAT™ coat-

Pictures: faCellitate, Nova Biomedical Schweiz

ings from faCellitate provide a highly defined, fully inert cell- and protein-repellent surface. The polymeric coating enables a faster generation of 3D spheroids, which shortens your experimental timeline and prevents the formation of satellites and irregular aggregates. Choose between the ready-to-use 96-well plate or DIY BIOFLOAT™ FLEX coating solution to modify a broad range of plastic and glass surfaces. One pipetting or rinsing step is sufficient to passivate your surface on the nanometer scale. Create a homogenous and robust coating for your cell culture vessels, microfluidic devices or chips, which is stable under standard culture conditions. The consis tent qualit y of t he ­B IOFLOAT™ surface makes it a premium product for 3D cell culture, ensuring reproducible data for all kinds of cell lines, including cells that fail to generate spheroids on existing products. .

Cell culture analysis   BioProfile

FLEX2 combines Nova’s groundbreaking MicroSensor Card technology with optical measurement and freezing point osmometry for an automated and comprehensive cell culture analyzer that eliminates chemistry sensor maintenance, increases analyzer speed, and reduces sample volume. The full 16 cell culture test menu includes: GLU, LAC, Gln, NH4 ,Na+, K+, Ca++, pH, PCO2, PO2 total cell density, viable cell density, viability, cell diameter and osmolality. Also available is the BioProfile FLEX2 On-Line Autosampler (OLS), a modular system that connects as many as 10 bioreactors to a FLEX2 analyzer for automated sampling and analysis of key cell culture analytes including pH, gases, metabolites, osmometry, cell density and cell viability. The OLS’ small sample volume and fast analysis time provide automated sampling and analysis of 10 bioreactors in less than 1.5 hours. Setup time for a full, 10-bioreactor system requires less than 20 minutes. With proven data comparability to manual sampling methods, the FLEX2 OLS can be connected to OPC-compliant control systems for automated sampling, analysis, and feedback control. .

36. JAHRES� KONGRESS PHARMAZEU� TISCHE MEDIZIN � ONLINE 12. Oktober 2020 SYMPOSIUM 1 Trends in Clinical Trials PANELDISKUSSION Real world evidence – Paneldiskussion mit interaktiven Elementen SYMPOSIUM 2 Immunooncology Wir möchten den gemeinsamen Austausch mit Ihnen auch in diesem Jahr nicht missen und gemeinsam über die oben aufgeführten brennenden Themen diskutieren! Der diesjährige Jahreskongress findet als Online-Kongress statt. Nähere Informationen und das vollständige Programm finden Sie unter dgpharmed-jahreskongress.de Wir freuen uns auf Ihre Teilnahme und Ihre Beiträge!

Contact

faCellitate – a venture of Chemovator GmbH Dr. Véronique Schwartz Venture Team Leader and BD T: +49 160 91963449 info@facellitate.com https://facellitate.com

Contact

Nova Biomedical Schweiz GmbH ch-info@novabio.com Nova Biomedical GmbH Deutschland de-info@novabio.com www.novabiomedical.com

Early-Bird-Rates bis

31.8.2020 www.dgpharmed-jahreskongress.de


80

Company Index

European Biotechnology | Summer Edition | Vol. 19 | 2020

A AbbVie Inc. (USA) . . . . . . . . . . . . . . . 56, 64 Accord Healthcare S.L.U. (ES) . . . . . . . . . 44 Adaptive Biotechnologies (USA). . . . . . . . 56 AI VIVO (UK). . . . . . . . . . . . . . . . . . . . . . 54 AiCuris GmbH & Co KG (DE). . . . . . . . . . 17 Amazon (USA). . . . . . . . . . . . . . . . . . . . . 15 Apeiron Biologics AG (AT) . . . . . . . . . 17, 23 Aptamer Group Ltd (UK). . . . . . . . . . . . . . 20 Arya Sciences Acquisitions(USA) . . . . . . . 69 AstraZeneca AB (SE/UK). . . . . . 3, 18, 20, 41 Atriva Therapeutics GmbH (DE) . . . . . . . . 29 Austria Economic Service Company. . . . . 23 AveXis EU Ltd. (IRL). . . . . . . . . . . . . . . . . 44

F

B BASF (DE). . . . . . . . . . . . . . . . . . . . . . 14, 15 Bavarian Nordic (DK). . . . . . . . . . . . . . . . 43 Bayer AG (DE) . . . . . . . . . . . . . . . 10, 56, 65 Bioascent Discovery Ltd (UK). . . . . . . . . . 49 BIOCOM AG (DE) . . . . . . . . . . . . . . . . . . 40 BioFIT & MedFIT 2020 (DE). . . . . . . . 73, 81 Biognosys AG (CH). . . . . . . . . . . . . . . . . . 49 BioNTech SE (DE). . . . . . . . . . . . . 18, 37, 69 BioVersys AG (CH). . . . . . . . . . . . . . . . . . 10 Boehmert & Boehmert (DE) . . . . . . . . 36, 63 Boehringer Ingelheim (DE). . . . . . . . . 10, 13 Bone Therapeutics (B). . . . . . . . . . . . . . . . 71 Bosch Healthcare (DE). . . . . . . . . . . . . . . 22

Gilead Sciences Internation (USA) . . . . . . 75

C Calliditas Therapeutics AB (SE). . . . . . . . . 65 Canopy Growth (CDN). . . . . . . . . . . . . . . 71 Carbios SAS (F). . . . . . . . . . . . . . . . . . 14, 71 Carna Biosciences Inc. (USA). . . . . . . . . . 70 Cassiopea SPA (IT) . . . . . . . . . . . . . . . . . . 66 Celgene Europe BV (NL). . . . . . . . . . . . . . 44 Centogene AG (DE) . . . . . . . . . . . . . . . . . 22 CORAT Therapeutics GmbH (DE). . . . . 3, 17 Cosmo Pharmaceuticals (IT). . . . . . . . 66, 69 Covestro Deutschland AG. . . . . . . . . . . . . 15 Cowen Inc. (USA). . . . . . . . . . . . . . . . . . . 37 CSL Behring GmbH (DE) . . . . . . . . . . . . . 65 CureVac AG (DE). . . . . . . . . . . . . . . . . . . 18 D Deep Lens Inc. (USA). . . . . . . . . . . . . . . . 53 Deinove SA (F). . . . . . . . . . . . . . . . . . . . . 49 DGPharMed (DE). . . . . . . . . . . . . . 53, 59,81 E Eli Lilly (USA). . . . . . . . . . . . . . . . . . . 10, 71 Emergent Biosolutions (USA) . . . . . . . . . . 41 Eppendorf Bioprocess Center Eur. (DE). . . . . 55 EUROIMMUN AG (DE) . . . . . . . . . . . . . . 33 EuropaBio (B). . . . . . . . . . . . . . . . . . . . . CP3 European Biotechnology Network (B). . . . 61 Evox Therapeutics Ltd (UK). . . . . . . . . 49, 71

faCellitate (DE). . . . . . . . . . . . . . . . . . . . . 79 Faron Pharmaceuticals Oy (FIN). . . . . . . . 65 FGK Clinical Research GmbH (DE). . . . . . 43 Fördergesellschaft IZB (DE). . . . . . . . . 45–48 Fosun Pharma (CN). . . . . . . . . . . . . . . . . . 18 Fraport GmbH (DE). . . . . . . . . . . . . . . . . . 22 G Galapagos NV (B). . . . . . . . . . . . . . . . . . . 72 GBA Group Pharma (DE). . . . . . . . . . 30, 35 GC Pharma. . . . . . . . . . . . . . . . . . . . . . . . 65 GE Healthcare Ltd. (UK). . . . . . . . . . . . . . 53 Genmab A/S (DK). . . . . . . . . . . . . . . . 37, 64 GlaxoSmithKline (UK) . . . . . . . . . . . . . . . 10 GNA Biosolutions (DE). . . . . . . . . . . . 21, 24 Grifols SA (ES) . . . . . . . . . . . . . . . . . . . . . 65 H Halix B.V. (NL). . . . . . . . . . . . . . . . . . 41, 70 I

N Nanome.ai (USA). . . . . . . . . . . . . . . . . . . 54 Nicox S.A. (F). . . . . . . . . . . . . . . . . . . . . . 43 Nova BIomedical GmbH (CH/D) . . . . . 9, 79 Novartis Europharm Ltd. (UK). . . . . . . . . . 44 Novasep SA (F). . . . . . . . . . . . . . . . . . . . . 70 Novavax Inc. (USA) . . . . . . . . . . . . . . . . . 18 Novo Holdings (DK). . . . . . . . . . . . . . . . . 10 Novo Nordisk A/S (DK). . . . . . . . . . . . . . . 42 O Octarine Bio (DK). . . . . . . . . . . . . . . . . . . 71 Oncoradiomics BV (B). . . . . . . . . . . . . . . 56 Orphan Biovitrum AB (SE) . . . . . . . . . . . . 65 Oskare Capital SAS (F). . . . . . . . . . . . . . . 71 P Paion AG (DE). . . . . . . . . . . . . . . . . . . . . . 69 Pepperprint GmbH (DE). . . . . . . . . . . . . . 25 Pfizer (USA). . . . . . . . . . . . . . . . . 10, 18, 69 PharmaMar S.A. (ES). . . . . . . . . . . . . . . . . 66 Pivotal S.L. (ES). . . . . . . . . . . . . . . . . . . . . 41 Polpharma Biologics S.A. (PL). . . . . . . . . GP4 Poxel SA (F) . . . . . . . . . . . . . . . . . . . . . . . 41

Immatics Biotechnologies AG (DE). . . . . . 69 Immunovative Therapies Ltd (IL). . . . . 22, 74 Indivumed GmbH (DE). . . . . . 51, 53, 57, 58 Innophore GmbH (AT). . . . . . . . . . . . . . . 69 Inovio Pharmaceuticals Inc. (USA). . . . . . 18 Insilico Medicine (USA). . . . . . . . . . . . . . 54 Integumen Ltd (UK) . . . . . . . . . . . . . . . . . 20 Ipsen Pharmaceuticals S.A. (F) . . . . . . . . . 49

Q/R Quest Diagnostics Inc. (USA). . . . . . . . . . 20 Randox Life Sciences (UK). . . . . . . . . . . . 22 RauCon GmbH & Co. KG (DE). . . . . . 32, 75 Rentschler Biopharma (DE). . . . . . 11, 34, 64 Roche (CH). . . . . 10, 17, 20, 42, 53, 56, 59, 61 Ryvu Therapeutics SA (PL) . . . . . . . . . . . . 72

Izana Bioscience (UK) . . . . . . . . . . . . . . . 41 J Janssen-Cilag International NV (B) . . . . . . 44 Jazz Pharmaceuticals plc (IRL) . . . . . . . . . 66 L Lufthansa AG (DE) . . . . . . . . . . . . . . . . . . 22 LuinaBio (AUS). . . . . . . . . . . . . . . . . . . . . . 7 M Mac Brooks Exhibitions Ltd. (UK). . . . . . . 81 MaaT Pharma (F) . . . . . . . . . . . . . . . . . . . 49 MC Services AG (DE). . . . . . . . . . . . . 26, 31 Merck & Co. (USA). . . . . . . . . . . . . . . . . . 72 Merck KGaA (DE). . . . . . . . . . . . . 10, 41, 43 Merck Millipore Sigma (USA). . . . . . . . . . 19 Mirror Biologics Inc.. . . . . . . . . . . . . . . . . 74 MLM Medical Labs GmbH (DE). . . . . . . . 67

S/T Sanofi-Aventis Group (F). . . . . . . . . . . . . . 44 SeraNovo B.V. (NL). . . . . . . . . . . . . . . . . . 70 SGS Belgium NV (B). . . . . . . . . . . . . . . . . 27 Shimadzu (DE). . . . . . . . . . . . . . . . . . . . CP2 Shire plc (IRL). . . . . . . . . . . . . . . . . . . . . . 64 Sinovac Biotech (CN). . . . . . . . . . . . . . . . 18 Sobi AB (SE). . . . . . . . . . . . . . . . . . . . . . . 65 SOM Biotech SpA (ES) . . . . . . . . . . . . . . . 66 Staidson Biopharmaceuticals (CN). . . . . . 41 The Hyve (NL) . . . . . . . . . . . . . . . . . . 56, 61 U/V UCB SA (B). . . . . . . . . . . . . . . . . . . . . . . . 42 Valneva SE (F). . . . . . . . . . . . . . . . . . . . . . 37 Vaxxim AG (CH/DE). . . . . . . . . . . . . . . . . 43 Vetter Pharma International (DE). . . . . . . . 41 Vibalogics GmbH (DE). . . . . . . . . . . . 59, 62 Vienna Business Agency (AT) . . . . . . . . . . 23

Modern Biosciences plc (UK). . . . . . . . . . 18 MSD Sharp & Dohme (USA). . . . . . . . . . . 10 Mylan IRE Healthcare Ltd. (IRL) . . . . . . . . 44 MYR GmbH (DE). . . . . . . . . . . . . . . . . . . 44

Y/Z Yumab GmbH (DE). . . . . . . . . . . . . . . . 3, 17 Zelluna Immunotherapies AS (NO). . . . . . 64


EVents

European Biotechnology | Summer Edition | Vol. 19 | 2020

DGPharMed Congress 12.10.2020 online  Due to the Co-

rona pandemic, the Annual Congress of the German Society for Pharmaceutical Medicine will be a virtual event. Symposium topics: “Trends in Clinical Trials and Immunoncology.” On a panel discussion experts talk about real world evidence. www.dgpharmed-Jahreskongress.de

23.–24.9.20 D4 Europe – Data Driven Drug Development, Basel (CH) Info: Frontline Genomics www.d4-europe.com 28.–30.9.20 Regulatory Science Forum, online Info: DIA, www.diaglobal.org. 1.–2.10.20 IFIB 2020: International Forum on Industrial Biotechnology and Bioeconomy, Rome (IT) Info: Assobiotec-Federchimica www.ifibwebsite.com 5.–16.10.20 CPhI: Festival of Pharma, online Info: CPhI Global Office, www.cphi.com

25.10.20 Europe CEO, Munich Info: Informa https://informaconnect.com/europe-ceo/ 26.–29.10.20 BIO-Europe digital 2020, online Info: EBD Group https://informaconnect.com/bioeurope 2.–4.11.20 World Bio Markets, Amsterdam (NL) Info: Robert Wilson, Green Power Conferences http://worldbiomarkets.com

BioFIT 7.–8.12.2020 Lille-Gathering 1,300

5.–9.10.20 EFIB 2020, online Info: EuropaBio, www.efibforum.com

24.–28.8.20 AMR Conference – Novel Antimicrobials and AMR Diagnostics, online Info: BIOCOM AG https://amr-conference.com 10.9.20 3rd World BioEconomy Forum, online (Livestream from Ruka, FIN) Info: World BioEconomy Forum www.wcbef.com

Pictures: XXX/Mack Brooks Exhibitions Ltd/© Vincent Eschmann

14.–15.9.20 EuroPLX 73 – The Marketplace for Pharma Business Opportunities, Vienna (AT) Info: Dr. Norbert Rau, RauCon www.europlx.com 17.–18.9.20 3rd ECP Summer Summit, online Info: BCNP Consultants GmbH www.ecp-susu.com

7.–8.10.20 6th PLA World Congress, Munich (GER) Info: Polymedia Publisher GmbH www.bioplasticsmagazine.com

delegates from 35+ countries, BioFIT has taken on a whole new dimension, becoming the meeting point in Europe for tech transfer, early-stage innovation deals, and pre-seed/seed/ Series A investment rounds in the Life Sciences.  www.biofit-event.com

19.–22.10.20 Analytica 2020, Munich (DE) Info: Katja Stolle, Messe München GmbH www.analytica.de

Chemspec Europe 11.–12.11.2020 Cologne   Chem-

spec Europe, the International Exhibition for Fine and Speciality Chemicals, returns to Cologne for its 35th edition. Renowned manufacturers, suppliers, and distributors of fine and speciality chemicals present their latest products, services, and research findings to a dedicated audience of industry experts. www.chemspeceurope.com

2.–4.11.20 Festival of Biologics, Basel (CH) Info: Derek Cavanagh, Terrapinn https://www.terrapinn.com 11.–13.11.20 Global Congress on Plant Biology and Biotechnology 2020, Valencia (E) Info: Grace Angel, Magnus Group https://plantbiologyconference.com

18.–22.9.20 ESMO Congress 2020, online Info: ESMO – European Society for Medical Oncology https://www.esmo.org

19.–20.11.20 Global Bioeconomy Summit 2020, Berlin (GER) Info: Conference office c/o BIOCOM AG https://gbs2020.net/home/

22.–23.9.20 Future of Biofuels – European Conference/ Biogas PowerON 2020, Copenhagen (DK) Info: FORTES, https://fortesmedia.com

23.–24.11.20 EuroPLX 74 – Marketplace for Pharma Business Opportunities, Athens (GR) Info: RauCon, https://www.raucon.com

81


Encore

No excuse!

I’m in biotechnology because ...

COVID-19   The cheap,

Climate Mitigation  Significant reduc-

worldwide-available corticosteroid dexamethasone reduced mortality by about one third in ventilated COVID-19 patients, compared to the current standard of care. The quarterly Chinese production capacity alone would be sufficient to treat 530,000 patients with the generic drug.

tions in human emissions could take decades until they lead to detectable changes in global surface temperatures, a study of Norwegian Climate researchers has found (Nature Comm., doi: 10.1038/s41467-02017001-1). Bjørn Samset and colleagues report that for emissions, including CO2, methane, and nitric oxide, it would take decades until a statistically measurable reduction can be detected in the global surface temperature. Although there is no detectable short-term response, mitigation of emissions, including CO2, methane, and black carbon, leads to substantially less warming over longer time scales. This should not be an argument against pursuing these efforts, as they need time to be effective, the authors warn. 

Dr Nathalie Huther, Sen. Dir. Business Dev. Europe, ARCINOVA

allogeneic Car-Ts Cellectis SA lost

“… because our mission is to improve people’s lives by working at the cutting edge of science. Working with multidisciplinary teams offers a highly diverse, fast paced, intellectually stimulating and exciting environment.”

COVID-19 testing outlook According to an analysis of Global Market Insights, the COVID-19 diag­nostics market develops in a highly dynamic way. The market researchers’ forecast that the global market for nasal swab kits, molecular and antibody-based diagnostics, strips, and cartridges will grow worldwide from April 2020 to April 2026, with a CGAR of 17.3% from US$3.3bn to a strong US$8.5bn. This does not even include antigen tests or new PCR hybrid formats for testing in minutes. European diag­ nostics providers lead the field with 57% of the market share. 

COVID-19 detection kits market, worldwide and Europe 9.0 8.0

World  Europe 

7.0

#Gilead announced #remdesivir price of $2340 per 5-day course, versus $5 production cost. Countries should prioritize #dexamethasone, which costs less than $20 per person, Dr Andrew Hill tweeted.  @DrAndrewHill

5.9 (69.4%)

17.3%

6.0 5.0 3.3 (100%) 4.0

21.0%

1.9 (57%) 3.0 2020

2021

#COVID-19 update Tesla is building mobile molecule printers to help make the potential #COVID-19 vaccine being developed by #CureVac in Germany, CEO Elon Musk tweeted.   @ReutersBiz

8.5 (100%)

CAGR Market share

Source: Global Market Insights

13% after the FDA ordered a clinical hold on the experimental, allogeneic CAR-T cell treatment UCARTCS1A to treat multiple myeloma. A patient died during the clinical study from treatment-related cardiac arrest. 

#BD launched a #coronavirus antigen test, 2nd to get FDA emergency authorization. The rapid, point-of-care di-

Please follow us @EuroBiotechNews agnostic joins #Quidel’s, tweeted Claude Waddington.  @Mr_C_Wadd

2022

2023

2024

2025

2026

Next issue Au t u m n e d i t i o n  O u t s o u r c i n g

biomanu­facturing and clinical testing is a huge growth opportunity with numerous players, pushing proprietary cell lines and processes. The CRO/CMO special in European Biotechnology’s Autumn Edition will be distributed widely. If you want to participate, please contact Andreas Macht (+49-30-264921-54), Oliver Schnell (-45), or drop us an email: marketing@biocom. de. Publishing date is 24 September 2020; deadline for ads is 11 September 2020. 

Pictures: Arcinova (top), Global Market Insights (bottom)

Winners & losers

European Biotechnology | Summer Edition | Vol. 20 | 2020

In billion US$ and % of market share

82


l a t i g i D Europe’s Leading Event on Industrial Biotechnology and the Bioeconomy 5 – 9 October 2020 · Live and on demand

Advancing the Green Economy with biotech innovation

June

The #EFIB2020 programme will focus on different indus-

July

try sectors and business areas. Each of the topics will be highlighted with insights, news and a pre-event webinar on sustainability challenges and opportunities after COVID-19. Additionally, virtual 1:1 meetings will be possible 24-hours/ day throughout the whole conference week.

Explore #EFIB2020 www.efibforum.com

Organised by

Supporting Partner

TOPIC CALENDAR

› Topic: Green. Circular. Sustainable › Topic: Food, Feed & Nutrition August

› Topic: Fashion & Textiles September

› Topic: Financing & Investing › Topic: Materials & Packaging October

› Topic: Bioprocesses & Technologies › Digital EFIB 2020 week:

All topics + 1:1 Partnering Meetings


INTEGRATED BIOLOGICS DEVELOPMENT TO SUPPORT YOU FROM DISCOVERY TO COMMERCIAL SUPPLY ŶƟďŽĚLJŝƐĐŽǀĞƌLJ

We have now integrated our Dutch based subsidiary, Bioceros, fully into Polpharma Biologics, enabling ƵƐƚŽŽīĞƌƚŚĞĐŽŵƉůĞƚĞƐƉĞĐƚƌƵŵŽĨƐĞƌǀŝĐĞƐĨƌŽŵ discovery to commercial supply.

ŶƟďŽĚLJKƉƟŵŝnjĂƟŽŶ

The change means Polpharma Biologics can now ĂĚĚŝƟŽŶĂůůLJŽīĞƌƚŚĞĚĞǀĞůŽƉŵĞŶƚŽĨŚŝŐŚƋƵĂůŝƚLJĂŶĚ ŚŝŐŚLJŝĞůĚĐĞůůůŝŶĞƐƚŚƌŽƵŐŚŽƵƌƉƌŽƉƌŝĞƚĂƌLJƉůĂƞŽƌŵ CHOBC®, as well as comprehensive discovery, process ĚĞǀĞůŽƉŵĞŶƚĂŶĚĂŶĂůLJƟĐĂůĐĂƉĂďŝůŝƟĞƐĨŽƌƚŚĞ development of novel biologics and biosimilar.

&ŽƌŵƵůĂƟŽŶĞǀĞůŽƉŵĞŶƚ

www.polpharmabiologics.com

Cell Line Development ŶĂůLJƟĐĂůĞǀĞůŽƉŵĞŶƚĂŶĚ ŚĂƌĂĐƚĞƌŝnjĂƟŽŶ;h^WĂŶĚ^WͿ

WƌŽĐĞƐƐ^ĐĂůĞͲƵƉ ůŝŶŝĐĂů^ĂŶĚWDĂŶƵĨĂĐƚƵƌŝŶŐ WƌŽĐĞƐƐsĂůŝĚĂƟŽŶĂŶĚŽŵŵĞƌŝĐĂů ^DĂŶƵĨĂĐƚƵƌŝŶŐ &ŝůůΘ&ŝŶŝƐŚ;ǀŝĂů͕W&^͕ĐĂƌƚƌŝĚŐĞƐ͕ ůŝƋƵŝĚĂŶĚůLJŽƉŚŝnjĞĚĨŽƌŵƵůĂƟŽŶƐͿ

Profile for BIOCOM AG

European Biotechnology Magazine Summer 2020  

European Biotechnology Magazine Summer 2020  

Profile for biocom

Recommendations could not be loaded

Recommendations could not be loaded

Recommendations could not be loaded

Recommendations could not be loaded