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AFFÄRSTIDNINGEN

Näringsliv

Time to Unite A Greater Medicon Valley

a journal about Life Science in Greater Copenhagen

Number 3 • 2019 • Issue 37

Countries and Companies Combatting Cancer

Clinical trials successful with new cancer vaccine targeting metastases

3 PolyPeptide is the Ultimate Partner for all Peptide Manufacturing Projects

4 Reach further with the right skills

7 Local clinical development services from Phase I to IV

A gamechanger in cancer diagnostics and treatment

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Integrated drug discovere platformtaking projects to the next level

Making it easier for people to work, study and live in the Oresund region

Petter Hartman, CEO Medicon Valley Alliance

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Countries and Companies Combatting Cancer Petter Hartman, CEO Medicon Valley Alliance If a single disease were to be identified as” Public enemy number 1”, cancer would be a good candidate. Practically every citizen in Denmark or Sweden know someone, who have suffered or died from either lung cancer, breast cancer, colorectal cancer or malignant melanoma, and although the relative survival has improved with time. In Denmark alone, 37.200 citizens are diagnosed with cancer each year and the number are expected to grow substantially, which is in part due to the fact that the population gets older.

With parallel challenges in both Denmark and Sweden, it can be no surprise that individuals, institutions and society as a whole have dedicated themselves and invested energy and resources to improve existing diagnosis and treatment, develop new treatments and combat cancer in practically every conceivable way. Besides being one of the most common diseases, cancer is also an area in which the region’s universities conducts extensive research. Ongoing research efforts focus both on understanding the basic mechanisms of cancer and on clinical studies which can more rapidly benefit patients.

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VISITING ADRESS Göteborgsvägen 27-29, Sävedalen

POSTAL ADRESS Box 2079, 433 02 Sävedalen PHONE 031-340 98 00 FAX 031-340 98 01

Petter Hartman, CEO Medicon Valley Alliance

Thanks to a well-functioning innovation system this research often leads to the creation of new start-ups and to commercialization. Several Medicon Valley based companies are at the very forefront of what is literally a life and death struggle. The willingness to invest in oncology-related companies indicates not only a general acceptance of the relevance of their common mission, but also the credibility and quality of the business case and R&D and general professionalism associated with regional oncology

related life science companies in general. The fact that Swiss pharma and biotech giant, Roche, which is one of the absolute world-leading companies within oncology, has chosen to invest in this region and actively scout for innovative R&D testifies to the quality of our regional oncology R&D ecosystem. The fact that Japans leading oncology company, Daichi-Sankyo, chose to establish their Nordic headquarter in Copenhagen last year, was probably no coincidence either. In Medicon Valley Alliance,

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we have embraced this development and in 2017 we established the MVA Oncology Network as a “meeting and market place” for oncology related industry, academia and hospital professionals. This forum, which was the brain child of the successful serial entrepreneurs prof. Carl Borrebaeck, Lund Universitet, and prof. Nils Brünner, University of Copenhagen, has now become the preferred go-to place, if you want to know the who is who, what, when and how of regional oncology-related R&D and commercialisation. We sincerely

hope and believe the network will also become a fertile forum for cross-fertilisation of innovative ideas and, consequently, pave the way for even more new Danish, Swedish or Danish-Swedish oncology companies. Although the MVA Oncology Network meetings are “MVA-members only”, I would like to invite interested companies and individual to contact me, and I will then be happy to extend a free of charge invitation to attend one of our next meetings.


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Clinical trials successful with new cancer vaccine targeting metastases The Swedish/Danish biotech company RhoVac is developing a therapeutic cancer vaccine, RV001, to prevent or limit cancer metastases. This may be a breakthrough in treating and even preventing cancer recurrence after primary tumour therapy.

Despite the advances in cancer detection and therapy leading to better survival rates, cancer metastases remain a major challenge, and account for around nine in ten cancer deaths. “Our approach to limiting or even preventing metastases is to create a cancer vaccine that has the potential to help the patient’s own immune system in targeting and attacking metastatic cancer cells. This aims to limit or prevent the recurrence of cancer after primary tumour therapy keeping the patient cured after local therapy” says Anders Månsson, vice President at RhoVac. Creating the cancer vaccine

RhoVac’s therapeutic cancer vac-

cine RV001 targets RhoC (Ras homolog family member C), a protein that is over-expressed in all cancer cells that have metastatic potential, across a wide range of cancer types. RV001 acts by triggering the production of RhoC-specific T cells. “Our researchers were looking for a target that is widely and strongly expressed in cancer cells and an antigen that plays an important functional role for the metastatic cancer cell, and RhoC has been identified by the US National Cancer Institute as a priority target for cancer vaccination. Many other cancer vaccines have not performed as expected, because they have focused on treatment in patients with a heavy tumour burden, which may be too big a job for the immune system to take on singlehandedly. Our approach is instead to prevent recurrence of cancer from potentially remaining isolated metastatic cells or undetectable micrometastases after primary tumour therapy”, Anders Månsson continues. In the clinical pathway, treat-

ment with the RV001 vaccine comes after the removal of the primary tumour with conventional cancer therapy, such as radiation or surgery. The aim is for the cancer vaccine to kill off the potentially remaining metastatic cells and as such prevent recurrence of the cancer. “On top of being effective, it is also important that therapy that comes right after curative intent therapy is well tolerated, as patients are ideally cured at this stage and will not accept severe side effects. Judging by our data so far, RV001 has every chance of living up to these demands”, says Anders Månsson. Next step will be a phase IIb and a licencing/ acquisition deal

The phase I/II trial, the first in human RV001 study, was conducted in post-prostatectomy prostate cancer patients who would otherwise have been monitored, but who would not have been receiving further treatment”. That study’s primary focus was

Anders Månsson, vice President at RhoVac.

on safety and tolerability. The secondary objective was to evaluate the specific immune response against RhoC. Results indicated excellent tolerability and a close to 90 per cent immune response rate that was stable over time. As such, RhoVac has now started on the last leg of its development journey, embarking on a >175 patient EU and US based phase IIb study in prostate cancer, aim-

ing to show, with statistical significance, the efficacy of RV001 in preventing or postponing disease progression after curative intent therapy (prostatectomy or definitive radiation therapy). The study will conclude in 2021 and by that time RhoVac aims to secure a licensing or acquisition partner for phase III and a global launch of the compound.

Early planning for future market success

















info@linkmedical.eu

YYour our LINK to // competence & tec technology hnology LINKMEDICAL.EU





 




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PolyPeptide is the Ultimate Partner for all Peptide Manufacturing Projects The Swedish subsidiary of the PolyPeptide Group is a major supplier to the continuing growth in peptide therapeutics worldwide. It has been estimated that the company at large, with six GMP manufacturing units in five countries, delivers a major portion of all outsourced peptide drug substances worldwide.

As a leading Contract Development and Manufacturing Organization (CDMO) for peptides and peptide related molecules, PolyPeptide offers state-of-theart facilities for undertaking both large-scale and smaller scale projects. Recent developments, including the successful incorporation of a new production site in Belgium, show that the company builds on its reputation as one of the world’s most trusted and preferred partners for peptide manufacturing projects. Broad Service Offering for Peptides

The PolyPeptide manufacturing site at Malmö, Sweden, has extensive know-how and experience of advanced therapeutic peptides for cosmetic, pharma-

Neil Thompson.

ceutical and veterinary applications. Together with its sistersites in Belgium, France, India and the USA, the Swedish site delivers one of the world’s most comprehensive manufacturing and supporting services relating to peptide drug substance. To maintain its broad service offering for synthetic peptides and peptide related molecules, the Swedish site has scaled up its manufacturing both by employing more experts on site and developing even better manufacturing processes. Lean thinking and the application of lean concepts are constantly applied in pharmaceutical manufacturing and PolyPeptide never stands still

with constant innovation and the adoption of new practices within the regulatory framework. The acquisition of the latest development and manufacturing unit in Braine L’Alleud, Belgium, has greatly enhanced the capacity throughout the group. The acquisition was completed in early 2017, and the last three years have been intense while all manufacturing operations and supporting functions have been aligned to PolyPeptide Group standards and practices. Significant investments in key manufacturing assets have been made, including new large & mid-scale Solid Phase Peptide Synthesis capabilities.

Neil Thompson, Senior Director Business Development Europe, commented on the acquisition and subsequent successful integration and called it “a unified transition with core-expertise and capacities that complement our existing know-how, resources and manufacturing foot print perfectly. With continued expansion across the group we will confirm our status as the ‘go-to’ peptide CDMO for all challenging & innovative peptide candidates who will deliver to defined project and manufacturing goals.” Visible at the front line

Peptides are widely used for developing therapeutics in many ar-

eas. Later developments include treatments for diabetes and obesity. Even therapeutics for rare diseases, as well as various forms of cancer are currently investigated using peptides. The next step for the PolyPeptide Group will be to expand the company services on a wider market and supporting the expansion of peptide therapeutics with more candidates entering clinical development for new indications and treatment areas. Overall – PolyPeptide will be visible at the front line of development in peptides and related areas worldwide, as the Ultimate Peptide Partner for any peptide project.


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Local clinical development services from Phase I to IV

WANT TO WORK OR DO BUSINESS ACROSS ÖRESUND? Come visit us and we can tell you more! Providing support from its offices in Sweden, Denmark, Norway and Finland, IRW Consulting is a clinical research organisation that is passionate about becoming a preferred partner in the Nordic countries. Bringing two decades of experience, IRW works with companies of all sizes.

In a fast-moving and continuously expanding pharmaceutical industry, the need for efficient and well-documented clinical trials is evident. A clinical research organisation (CRO) is a service organisation dedicated to the pharmaceutical and biotechnology industries, offering value-added services to promote the research and development process in each field. IRW manages clinical trials from start to finish and can also act as an integrated part of a client’s research team in-house. Clinical projects from Phase I to IV

With five offices across the Nordic region, IRW is ideally placed to provide clinical development and post-marketing support for companies of any size. “Our local expertise and contacts mean that we can help our

clients to conduct phase I to phase IV studies, including paediatric and non-interventional studies, as well as medical device investigations, according to both international and country-specific guidelines”, says Ola Jeppsson, CEO of IRW Consulting. In addition, IRW has the capability to cover more than just the Nordic region. Through a network of partners across the rest of Europe and the USA, IRW has the ability and capacity to conduct clinical projects globally. To ensure that these hand-picked collaborators meet its own high standards of quality, IRW makes sure that they have robust quality systems in place, including welldocumented standard operating procedures, solid finances and a history of good performance. Maintaining efficient projects

As a full-service agency, IRW can manage projects from beginning to end. Clients range from start-up companies to multinational pharmaceutical corporations. “We are able to meet the high demands of our clients and maintain projects efficiently. We have experienced staff and management. We have secured stable business during the past years,

Information Centre Øresunddirekt, Hjälmaregatan 3 in central Malmö

Contact and opening hours available on oresunddirekt.com

Drop-in – all year around

Read more on oresunddirekt.com

Ola Jeppsson, CEO of IRW Consulting.

large parts of the success being due to efficient and strategic planning on our part. We are ready to take on almost any clinical project”, says Ola Jeppsson. Lately, IRW has taken a much more prominent role in projects related to medical device investigations as well as rare diseases. Oncology is still widely represented through the project portfolio. IRW is currently recruiting, with opportunities for clinical research associates and clinical research managers in Denmark, Finland, Norway and Sweden.

The pharma packaging specialist – in mind and heart Eson Pac AB Box 125, 432 07 Veddige, Sweden www.esonpac.com

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Priming the Immune System to Fight Cancer Immunicum AB (publ) has established a unique immuno-oncology approach for the treatment of cancer through the development of allogeneic, off-the-shelf cellbased therapies. Ilixadencel, the Company’s lead product, is currently being evaluated as an immune-activating therapy in clinical trials for the treatment of a range of solid tumour indications.

One defining characteristic of cancer cells is their ability to “hide” from the immune system and thereby avoid detection and subsequent destruction from immune cells. Recent discoveries in the oncology field have allowed researchers to develop therapeutics and add-on treatments that reactivate the immune system.

stimulate the immune system. Injecting ilixadencel directly into the tumour triggers a local inflammatory reaction, similar to that seen in a viral infection. This inflammation destroys tumour cells and activates the immune system against the tumour, recruiting the patient’s dendritic cells to engulf the fragments of tumour cells and the range of neoantigens (mutated antigens that are specific to the tumour). The dendritic cells then alert other immune cells in an adaptive systemic response that is personalised to the individual patient’s tumour. “We believe that we have created an off-the-shelf agent that has potential as a therapy against a wide range of solid tumours and that requires no genetic manipulation making it simpler to manufacture, store and administer”, says Immunicum CEO Carlos de Sousa.

Targeting solid tumours

Immunicum’s approach is to create off-the-shelf cell-based therapies that boost the patient’s own immune system to fight cancer. As such, ilixadencel, is manufactured from the dendritic cells of healthy donors that have been activated to produce factors that

Combination approaches

Immunicum is currently assessing ilixadencel’s potential in a variety of solid tumours including renal cell carcinoma, hepatocellular carcinoma, gastrointestinal stromal tumours (GIST), head and neck squamous cell carcino-

ma, non-small cell lung cancer and gastric adenocarcinoma. “Cancer treatments are increasingly focused on combination approaches. We believe that our approach could be used as a backbone therapy along with checkpoint inhibitors, chemotherapy and tyrosine kinase inhibitors (TKIs), such as sunitinib. One additional benefit is the excellent safety and tolerability of ilixadencel that has been demonstrated in several clinical studies to-date”. Current key Phase Ib/II study

Ilixadencel first moved to clinical trials in 2012. The completed Phase I/II open-label study in patients with newly diagnosed metastatic renal cell carcinoma was presented in a number of papers and posters. This trial was followed by the MERECA openlabel Phase II controlled study evaluating ilixadencel plus sunitinib compared with sunitinib alone in metastatic renal cell carcinoma. MERECA closed enrolment in January 2018 and positive results were disclosed during the third quarter of 2019. “Beyond the positive news from MERECA, we now have

Carlos de Sousa, CEO.

another key Phase Ib/II study in place, known as ILIAD, which combines ilixadencel with checkpoint inhibitors, including Keytruda® (pembrolizumab), in head and neck cancer, gastric cancer and non-small cell lung cancer. The study is ongoing in the United States and will expand into Europe in the Phase II part of the study supported by our col-

laboration with Pfizer and Merck KgaA”, explains Carlos de Sousa. Preclinical development programs at Immunicum include opportunities based on the IMM-2 (formerly Subcuvax-Adenovirus) and IMM-3 platforms (formerly CD70) that are currently in research and preclinical evaluation.

Stronger together – building alliances across life sciences The core focus of Lundbased company MultiHelix is building alliances in the life sciences sector. To date, the membershipbased company has successfully built strong cluster and science parks collaborations through its own personal networks across three continents. Making the very best out of every member´s abilities and sharing it with others is the key to successful development and new partnerships.

The whole idea of MultiHelix is to bring people with the right knowledge and expertise together. This is done through several activities and channels, such as the Twins’ International MultiHelix initiative (TIM), and the MultiHelix Think Tank (MTT). In addition, MultiHelix as a company is equipped to be a one-stop-shop for any company, scientist or innovator within the TIM network, looking to set up business in another country.

2016. In just three years, the platform has successfully expanded and now, at the end of 2019, includes nine countries over three continents: Europe, North America and Asia. For the first time, the members representing each nation were able to attend the TIM annual meeting and at the same time take part in an elaborate MTT workshop on the theme future healthcare. The annual meeting was synchronised with the Nordic Life Science days in Malmö, Sweden, in September 2019. “Running these activities in synchronisation was most likely the best way to initiate our new members from Austria, Japan, Hong Kong and Spain. We were able to address issues that are relevant to everyone, as the theme future healthcare embarks on challenges that are equal to all, no matter where you live or come from”, says Ursula Hultkvist Bengtsson, Founder and CEO of MultiHelix AB in Lund.

Initiating new members

Addressing challenges together

TIM started out as a close collaboration platform of five countries in Europe and North America in

One of the challenges addressed during the TIM annual meeting and the MTT workshop was the

development of a future healthcare system that can cater to an aging population, which has become very much of a global challenge. The very idea of MultiHelix is for members to look at challenges in unison, and possibly develop solutions that work in all regions. “Key activities in 2020 include identification of the main strengths in each cluster. We are essentially looking to bring forward the very best from each

cluster and build common grounds for collaboration. Everything we do revolves around increasing the number of cross-border partnerships”, as Ursula Hultkvist Bengtsson explains it. In the beginning, the MTT activities involved around 20 professionals. Today, that number is exceeding 100 individuals coming from more than 50 different organisations. In other words, MTT is a great resource of knowledge and ideally an envi-

ronment of mind expansion. Some examples of common themes discussed during the MTT events are future healthcare and digital systems, food in connection to health and sustainability, prevention of disease and promotion of health, and everyone’s right to healthy lives and well-being according to the United Nations’ sustainable development agenda 2030.

Core Partners of MultiHelix Think Tank. Heiko Herwald, Medical Faculty, Lund university; Kerstin Jakobsson, Medicon Village Innovation AB, Harald Lindström, Advisor, MultiHelix; Ursula Hultkvist Bengtsson, MultiHelix and Lennart Svensson, Region Skåne. LIF – The research-based pharmaceutical industry is missing in the photo.


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Karolina Schiötz.

Reach further with the right skills In the new labour market, permanent employment is more often replaced by temporary assignments. This includes all employees who are interested in a freer assignment, whether self-employed or employed by a consulting company. A Society brings the best of the best together.

A Society is a gathering place for the most skilled consultants, whether they belong to a consulting company or are self-employed. Over 1300 consultants are employed through A Society on assignments around the world, in various industries such as automotive, bank and financial services, civil services and life science. The challenges of a translational industry

Life science is a very translation-

al industry where many different skills meet. More often than not there is advanced specialist expertise in chemistry, biology, IT, natural sciences, business development and research – all gathered in the same company. “The complex organisational structure and the nature of life science business requires indepth expertise, with professionals that are flexible and can collaborate in translational teams. A Society understands that challenge and can help companies in life science to develop further with the right skills available at the right time”, says Karolina Schiötz, Business Area Manager Life Science at A Society. Ideally, A Society works to maximise the benefits in the variable labour market, both for consultants and clients. “Our job is to help both consultant and client with the perfect match. “We work according to a transparent and

simple model. We offer a community of consultants, stable financial transactions and a contact person at A Society that really knows the company as well as the consultant. This creates added value and a strong personality in all we do”, Katarina Schiötz continues.

oping our ability to help our global customers with local delivery of senior specialists. Together with specialists in our offices in Europe, North America and Asia, our Business Area Manager Life Science Karolina

Schiötz will ensure the success of our customers – both locally and globally”, says Thomas Goréus, CEO and President A Society.

Making life science a priority

Through a stand-alone gathering place where competence and confidence are focus, A Society can always choose the person most suited for the assignment. The consultants receive developing assignments that help build their careers, while clients receive advanced solutions and specialist expertise. Through strategic competence supply, A Society can help customers reach the desired position and goals. “Life science is a priority area for A Society and we are devel-

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Making it easier for people to work, study and live in the Oresund region Øresunddirekt is a collaborative information arena for both citizens and businesses operating in the Oresund region of Sweden and Denmark. The geographical distance across the strait is minimal, but the operational distance may be perceived as a bit longer if the right information has not been put across.

The aim of Øresunddirekt is to bridge the gap between citizens, businesses and authorities on both side of the Oresund strait. This is done by providing an accessible platform for information gathering, sharing and updating. Øresunddirekt is ideally an arena or virtual meeting point, where professionals and companies can obtain information crucial to them in order to expand in Sweden and Denmark. Information platform for all

Øresunddirekt has been established to make it easier for people to work, study and live in the Oresund region. There is already a large number of people commuting to and from Denmark from Sweden and vice versa, but

there are yet more to come. Øresunddirekt is not just a resource for professionals, but for businesses as well. The key activities include supporting information in setting up a new business, information regarding employment and recruiting professionals across country boundaries, and marketing activities supporting

local Oresund collaborations. Øresunddirekt is essentially an information platform for all businesses and industries. Considering the large number of life science companies in the Oresund region, it is essential to have a good and solid guide in place for them. “In the life science industry,

translational teams are often required, and they are more often than not found somewhere across the strait. To make their journey across as smooth as possible, we are here to provide the contacts and information they need to set up both home and business on either side of the strait”, explains Sandra Forsén, Head of Office at

Øresunddirekt in Malmö, Sweden. Alert, available and visible

Companies and professionals are able to ask questions to experts online, or on site at the office in Malmö where a number of Øresunddirekt employees from different authorities are able to answer questions daily. If the question is more specific, Øresunddirekt offer meetings once a week where they gather Danish and Swedish business advisors and authorities. For example, representatives from the Swedish tax office, who are available for meetings on site. Other common activities include meetings about attracting and recruiting staff. The need to fill a competence shortage is becoming more and more evident throughout the Swedish industry, and the life science sector is not excluded from this challenge. “We have to work even more proactive, creating more opportunities on both sides of the strait, if we are to maintain a healthy industry here. This is what we have planned for the future – to become more alert, more available and more visible”, Sandra Forsén concludes.


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The CRO best known for its personnel A Contract Research Organisation (CRO), Stockholm-based A+ Science offers services in clinical trials for both pharmaceuticals and medical devices. The services are provided with a focus on clinical trial management, outsourcing of consultants and pharmacovigilance.

A+ Science was founded in 1997 by a team of cardiovascular researchers around the management of a large clinical study known as ASCOT. This involved almost 20,000 patients across the Nordic region, the UK and Ireland, and resulted in changes in national and international guidelines in lipid-lowering and the optimal management of hypertension. Shortly after that, and most likely related to the success of the study, the company expanded. After opening several offices across Sweden, and providing clinical trial, continuing medical education and outsourcing of consultants., A+ Science restructured in 2013 and became a CRO run by its employees. Client relationships first

One of the main things that

Johanna Andlin (Head of Clinical Operations) och Jennifer Heyno (CEO).

makes A+ Science different is that all employees are also shareholders, creating a simpler, flatter organisation. “Our aim with the restructure was to make A+ Science the CRO best known for its personnel and its focus on client satisfaction”, says Jennifer Heyno, A+ Science CEO. “Today, there is an openness and enormous engagement from all employees. We all agree and believe that client relationships are the most important thing. Many of our clients do not have any experience from previous clinical trials, so it is very important to us that they feel confident

that they have chosen a CROpartner that provides good quality services with qualified personnel”, Jennifer Heyno continues. All services can be tailored

A+ Science works with clinical trials from phase I to phase IV for pharmaceuticals as well as studies for medical devices, across all therapeutic areas. “All our services can be tailored to individual clients, and include writing from protocols to final reports, protocol development and submission, project and data management, clinical monitoring, pharmacovigilance, and regulatory services”, says Johan-

na Andlin, Head of Clinical Operations. She explains further that A+ Science also provides clinical trial and safety and pharmacovigilance personnel to other companies on a short-or long-term basis, from entry to management level. Expanding in pharmacovigilance

The company’s plan is to grow organically, rather than expand quickly through acquisition. To meet clients’ needs, A+ Science has a well-established network of

partner CROs and consultants, particularly for bigger projects, or for clinical trials that extend beyond Sweden. “Pharmacovigilance is a growing area; more and more companies are turning to us for assistance with those services. We have a fantastic and ambitious team. We can provide a full-service or customised pharmacovigilance solutions or support within specific pharmacovigilance functions. Anything is possible – and we make it happen”, concludes Johanna Andlin.

Complete range of IP services in one place Patents, trademarks, design rights, copyright and database rights, IP litigation, appeals and oppositions, transactional IP, due diligence and freedom to operate – the world of IP and related services may be overwhelming even to veteran innovators. HGF is a reliable and professional partner in understanding and making the most out of IP services.

HGF has a strong presence in the UK and Europe but has so far been operating behind the scenes in the Nordic countries. This is something that Gareth Probert, Partner at HGF, is looking to alter. With a long tradition and experience in working with life science companies of all sizes, Gareth Probert is now introducing HGF and the company profile to clients in the Nordic region, starting with Sweden and Denmark. “What we can offer is in-depth knowledge and expertise from a truly European partner in all aspects of IP. HGF is represented throughout the UK and Europe with 22 offices. We are anything but a satellite organisation, with over 400 experts where over 200 are attorneys, operating through-

out the UK and Europe”, says Gareth Probert. Any need, any issue

HGF has the power and capacity, knowledge and expertise to offer a complete range of IP services. With specialist knowledge and experience in almost all categories within life science, ranging from fundamental research in microbiology to the development of therapies based on newly created molecules, HGF can cater to any need that may arise. “Clients can expect in-depth

experience from us at any stage of development. We are also providing services to all kinds of businesses in life science, from the very small and local start-ups to large pharmaceutical companies with a global presence, regardless of the complexity of the issue”, Gareth Probert continues. Protecting clients in all stages

Getting it right the first time around is crucial when it comes to protecting innovations. It also means that clients are able to be-

come more strategic in their approach, being able to reach market release earlier and without mishaps on the way. Protecting innovations is not only focused on protecting one’s own developments, but also being able to keep up with what competitors are doing. Thus, HGF offers a complete service in monitoring pending patents on behalf of clients. As soon as any patent is identified which may harm the business of the client, HGF is able to assist in filing an opposition against that patent.

Gareth Probert.

Patent monitoring and filing opposition is an extremely important service, which has saved many clients from throwing money at the wrong development just to realise later that they lack freedom to operate. This is an excellent example of a very common challenge in the life science industry, and it is a challenge that HGF can help clients through.


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Addressing the challenge in translational medicine Truly Labs is a contract research organisation based at Medicon Village with a focus on in vitro and in vivo preclinical research services, from strategic plans through study design to evaluation and analysis of the data.

The step from preclinical trials to clinical trials can be a challenging one, and a lot of otherwise promising drugs fall by the wayside. “The challenge in translational medicine is when companies start to look at drug efficacy at phase II and find that their drug isn't working as they expected. This is very disappointing, and failure at this stage is costly”, says Karin von Wachenfeldt, CEO Truly Labs. To deal with this challenge, the Lund-based research organisation Truly Translational set up Truly Labs in 2015. Using its experience in drug development to create tailor-made in vitro and in vivo services, Truly Labs helps companies to understand whether their drugs have potential in the clinic as early as possible in the drugss life cycle, and this approach could help to lower the

very high attrition rates in early drug development. Understanding impact before moving on

To achieve accurate results, Truly Labs consultants look for efficacy markers that can be used both in preclinical and in clinical studies. For example, they perform biomarker analysis, animal and human cell assays, multiplexing, PK/PD experiments and whole body imaging to create correlations between in vitro and in vivo outcomes and animal and human responses. This helps to better understand mode of action, dose, exposure at the target and efficacy, allowing a clearer picture of what the impact of the drug will be when it moves into human studies. Truly Labs covers a range of important therapy areas, including inflammation, oncology, respiratory diseases, gastrointestinal disease, and autoimmune diseases, and provides expertise in preclinical in vivo inhalation pharmacology services. These therapeutic areas are driven by market needs and by the background expertise of the Truly Labs’ team, largely originating from Astra Zeneca’s inhalation

Karin von Wachenfeldt

and respiratory team. Truly Labs is a part of the Medicon Valley Inhalation Consortium. The role of translational research

Translational research is not just important for a company’s internal development programs. It makes up an important part of packages provided for potential licensees and investors, and for dossiers for regulatory authorities for approval of clinical trial plans, and eventually, for marketing authorization. “We are not just an average preclinical CRO. We know how

to develop drugs, and we know what kind of data and what level of quality is needed to get approval to go into the clinic or to attract a pharma partner”, says Karin von Wachenfeldt. Truly Labs’ team prides itself on having a customer-centric approach. “Because we understand the time and financial challenges in drug development, especially for smaller biotech companies, when our customers come to us with a request for a study, we will discuss their program with them. We will jointly identify the critical data to be generated, and in this process take the translational

aspects into account. We want to make sure that our customers carry out the right studies, of the right size and at the right time”. Karin von Wachenfeldt continues: "Flexibility is key to how we work – for some companies we act effectively as their internal laboratories, and for others we work on specific questions or models”. This customer-centricity does not stop at the end of the project. Through its network of contacts, Truly Labs’ team can help its customers to find outsourcing partners for other services, such as toxicity and safety studies.

Eson Pac is ready for the development of Precision Medicine Packaging manufacturer Eson Pac is often called the pride of Veddige, a small community in Varberg on the Swedish west coast. And rightly so – Eson Pac is a growing company largely based on local manpower. More than half of the employees are from the region and the family business culture remains despite continuous expansion.

Eson Pac has succeeded in what many other manufacturing companies can only dream of. The production figures are doubled – but the workforce remains the same. And it is still a great place to work – many of us are wondering how that can be possible? It is a matter of good planning and optimisation of resources, but is that all? Impressive transformation

Eson Pac has made an impressive transformation from multi-purpose carton producer to a producer of high quality and precision products. “Since 2018, we are focusing entirely on the pharma-

ceutical industry”, says Niklas Bengtsson, Sales and Markering Director at Eson Pac. The company produces cartons, labels and instructions for use. Standards are set high within the entire pharmaceutical sphere, and Eson Pac is no stranger to complex projects. “At the plant in Veddige, we have a high-efficiency cartons manufacturing line that is worldclass. It testifies our ability to produce to extremely high standards of quality and precision”, says Niklas Bengtsson. Eson Pac was founded as early as 1967 and collaboration with big developers in Pharma commenced only a few years after that. With decades of experience, Eson Pac can meet the demands of the modern pharmaceutical developers and manufacturers. Trending: patient targeted batches

Considering demographic trends across the globe, it becomes clear that an aging population will require more extensive care and more pharmaceutical drugs are to be produced as a result of that. The use of medicines and medical devices in most segments is

not likely to decrease any time soon. Thus, the vast opportunities within Pharma has set the guideline for Eson Pac’s future investments. “It is a growing market and we intend to be a partner here for many years to come. At the same time, the pharmaceutical market is a complex one that is rapidly changing”. Niklas Bengtsson sees both opportunities and challenges for the future. “The current trends suggest that we will see more of Precision Medicine soon. For us, this means smaller and more patient-targeted batches to be produced”, he says. As we can be sure to reap the benefits of a more personalised care and increased person-oriented treatments, the manufacturers of the products making it possible can also be sure of one thing and that is an even higher demand when it comes to the manufacturing process. “Producing smaller batches is not easier, and not cheaper. Quite on the contrary. What we must do now is to continue developing our operations to meet the demands of the future – small batches produced at high speed – at a lower cost”.

Niklas Bengtsson, Sales and Markering Director at Eson Pac.


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Integrated drug discovery platform taking projects to the next level The team at Red Glead Discovery in Lund has perfected the design and execution process of pre-clinical drug discovery. The company has successfully delivered drug discovery solutions to around 200 clients so far, where academics, biotech start-ups as well as Big Pharma companies are represented.

The integrated drug discovery platform developed and implemented by Red Glead Discovery is powered by high-value partnerships on all levels from discovery to validation. This provides the means to progress projects from

target validation to lead optimisation and grants the client peace of mind in knowing that the team at Red Glead Discovery has all the necessary tools at hand. Designing, making and analysing molecules

The core competence at Red Glead Discovery is related to the discovery and development of small molecules and peptides. Within any project, the team at Red Glead Discovery provides deep knowledge in organic and analytical chemistry, bio-chemistry and biotechnological platforms. “In close collaboration with the client, we perform all essen-

tial activities needed to take their project to the next level. We design, make and analyse molecules, and identify those molecules with the highest chance to be turned into a drug that can be given to patients”, Red Glead Discovery EVP Martina Kvist Reimer explains. To succeed, this effort requires the collaboration of a diverse team consisting of experts in analytical, organic and medicinal chemistry as well as biology, and importantly, access to specialised technological platforms which is the Red Glead Discovery forte. “For example, successful fragment-based hit generation is enabled by the unique WAC (Weak

affinity chromatography) technology, permitting screening for novel chemical starting points in a truly time- and cost-efficient manner”, says Martina Kvist Reimer. Helping clients reach clinical phase and beyond

The very early stages of drug discovery profit the most of Red Glead Discovery’s integrated approach, but by virtue of its excellent analytical capabilities the company is sought-after partner for late-stage and manufacturing companies. Being part of the vibrant Medicon Valley Life science cluster of the Öresund region, the company can associate

new partnerships tailored to new project preliminaries without delay. This is only the beginning for Red Glead Discovery. The team stays committed to expand the company’s capacity to help clients reach the next phase of their project. The company has 35 employees and has been nominated one of the fastest growing Life Sciences companies by the Swedish business journal Dagens Industri in 2019.

The new generation of cancer treatments Cantargia's CAN04 antibody treatment fights cancer by activating the immune system, and by blocking signals that lead to tumour growth.

www.cantargia.com

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Antibody based cancer treatment with multiple functions Cantargia’s antibody-based cancer treatments may eventually change the lives of millions. Focusing initially on lung cancer and pancreatic cancer, the goal is for Cantargia’s lead drug to increase the life span as well as the quality of life in a very large patient group, targeting more cancer diseases as clinical results excel.

The importance of the role of inflammation in cancer is becoming increasingly recognised by researchers. Treatments that effectively attack cancerous cells, as well as counteracting chronic tumour inflammation, are more sought after than ever –Cantargia’s lead antibody CAN04 is designed to include both aspects. The last year two additional important findings were made: The antibody blocks the spread of metastases and counteracts resistance against standard chemotherapy. Changing oncology

Over the past ten years Cantargia has developed its lead drug, CAN04, based on a finding and research from Lund University.

Cantargia pipeline.

Novel findings during 2018 show additional therapeutic potential for CAN04 treatment: counteracts formation of metastases and gives a synergistic effect with chemotherapy.

CEO Göran Forsberg.

Standards were set high from the very beginning. The development has gone from the discovery in the academic environment to a public phase II clinical stage company in less than ten years. The lead drug is currently investigated in patients with pancreatic cancer or lung cancer. The phase I data received strong international recognition when selected for an oral presentation at the 2019 ASCO meeting in Chicago, the major annual cancer conference. CAN04 has the potential to play an important role in several parts of both current and future cancer treatment strategies. The phase I/IIa study, known as CANFOUR, began with an evaluation of the safety and tolerability of CAN04 at escalating dose levels in five clinics in Belgium,

the Netherlands, Denmark and Norway. The second part, aiming to get an initial indication of antitumour activity, involves more patients at around 20 centres in several countries. The next step will be a more focused development in the most promising of these diseases. “Considering recent advances, in the most aggressive scenarios it is possible that CAN04 can be approved as early as early as 2023”, says Cantargia CEO Göran Forsberg. Cantargia has granted patents around the target molecule until 2032, and the lead drug developed by Cantargia is patented until 2035. Other areas of interest

CAN04 may also have potential to make a difference in treating

breast cancer, various forms of leukaemia, liver cancer, oesophageal cancer and head and neck cancer. The core technology developed by Cantargia also has potential for various applications in autoimmune diseases. Thus, the company has already started developing a second antibody for the treatment of autoimmune and inflammatory diseases, now close to selecting a product candidate. “In our biological platform, it is a small step from cancer to autoimmune disease. We are also aware that expanding the areas we focus on also reduces risk for us and for our investors”, says Göran Forsberg.


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New technology can improve person-centered care Scionova is a company with communication, connectivity and connected systems as specialty. In healthcare and medical technology, flawless connections are essential, as well as constant monitoring of critical systems. This is what Scionova does.

The Internet of Things (IoT) is no longer science fiction. We live in a reality where we are constantly surrounded by technology and devices that communicate with us and with each other without us having to do much. In order for this scenario to be sustainable over time, someone has to take care of system possibilities to develop as well as continuous connectivity. “Our technology solutions already exist in millions of units. We help our customers connect products for many purposes, for example to streamline operations or to simplify users' lives. We also conduct preliminary needs analysis of companies' existing functions and suggest solutions and improvements based on that”, explains Henrik Sjöström, Scionova CEO. Breaking new ground in Medtech

The modern automotive industry is an example of a growing customer base in which Scionova has already been involved in developing the next generation of connected cars, but major changes are also taking place within Medtech with healthcare rapidly being digitized. Scionova is looking to break new ground within this field. “For example, we have ongoing projects in medical technology where we develop products and solutions to improve and streamline person-centered care. You should be able to read your own values with the help of tech-

Joakim Ceder and Peter Fredriksson.

MultiHelix AB works in co-operation with Life Sciences, ICT and Food sectors in: - MultiHelix Think Tank - Twins´ International MultiHelix If you want to join, mail us at: info@multihelix.se or meet us at Medicon Village, Lund You can find more at www.MultiHelix.se.

RhoVac AB Medicon Village | Scheeletorget 1 | SE- 223 81 | Sverige RhoVac Aps Agern Alle 24 | DK 2970 Hørsholm | Danmark P: +46 (0) 73 751 72 78 | E: info@rhovac.com | www.rhovac.com

Utrota barncancer. Din gåva gör skillnad. Henrik Sjöström, Scionova CEO.

nology and if something is not right, you can contact the healthcare system based on that. Some systems should even be able to alert the healthcare providers automatically, without the user having to do so”, Henrik Sjöström explains further. The modern person-centered care is already high-tech and is essentially about preventing diseases using digital tools. As a patient you should always be connected. There are many examples, one is that it is always possible to measure current values with the help of a seemingly simple bracelet that the patient wears. A lot has also happened in the area of diabetes, where pa-

tients themselves can make their own diagnosis and start taking measures with the help of technical means. Application: improved communication in hospitals

Scionova was founded by Peter Fredriksson and Joakim Ceder, both having worked with connected solutions as a master’s degree project at Halmstad University. The founders also collaborated with researchers at the university, aiming to explore new application methods of Bluetooth in industry. This is now applied in the development of communication platforms in hospital environments, among other things. “We collaborate with Medtech companies which have several different solutions for improved communication systems in the medtech and hospital environment. Here, as in the automotive industry, safety plays a major role. Patient information should be kept secure from unauthorized intrusion, but at the same time, cooperation should run smoothly between different units within the healthcare system”, says Henrik Sjöström. Technology development is rapidly increasing. The industrial customers of today use the technology that was only at research level when Scionova was founded. Embracing new ideas and taking the step to invest in ground-breaking innovations is the future – and the founders of Scionova knew that several years ago.

barncancerfonden.se Pg 902090-0  

!" !" Nanomaterials for improved cancer diagnostics and treatment

RED GLEAD DISCOVERY Red Glead Discovery Scheeletorget 1, S-223 81 Lund, Sweden www.redglead.com


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A gamechanger in cancer diagnostics and treatment The Lund-based Swedish company Spago Nanomedical may change everything we previously believed possible when it comes to cancer diagnostics and treatment.

Ever since the company was founded in 2007, Spago Nanomedical has developed nanomaterials for improved cancer diagnostics and treatment. The initial invention was based on the use of gadolinium-based nanoparticles as a contrast agent for MRI. However, after the finding that gadolinium was linked with a serious and non-treatable side effect; nephrogenic systemic fibrosis, in patients with impaired kidney function, the company moved towards a different focus. Namely on manganese, which has high-contrast enhancement on MRI. This became the basis for the company’s imaging product SpagoPix back in 2011. In 2014, Spago Nanomedical began development of its next product, the tumour-selective radionuclide therapy Tumorad®. Close to licensing SpagoPix

SpagoPix, Spago Nanomedical’s cancer selective MRI contrast agent, has moved through its first clinical trial including around 20 breast cancer patients. The nanoparticles are tumourselective because of the enhanced permeability and retention (EPR)

effect in tumours, a phenomenon leading to accumulation of particles of a certain size in tumour tissue. The study has thoroughly documented the product’s safety and ability to enhance MRI images. The main study objectives were to investigate safety of SpagoPix as well as ability to improve MR images in breast cancer patients. “Our aim is to outlicense SpagoPix based on clinical data, and any early proof-of-principal results from this study will steer our licensing discussions. As well as providing funding, this could begin our shift towards becoming a therapeutics company”, says Mats Hansen, Spago Nanomedical CEO. SpagoPix’s clinical development has been supported by grants from the Swedish government agency for innovation Vinnova. Hoping to make a difference

With SpagoPix successfully delivering in clinical trials, Spago can direct more focus to Tumorad®. The treatment is made up of nanoparticles loaded with radionuclides. Tumorad® could

have therapeutic potential in a range of soft tissue tumours, and may be complementary or even synergistic with other approaches to cancer treatment such as immunotherapy. “As a small organisation we had to focus on one product initially. As SpagoPix is now in the hands of a CRO, we can spend more time on our second product. Our aim is to design nanoparticles that have a half-life in vivo that matches that of the radioisotope, and we now have a prototype”, says Mats Hansen. Preclinical proof-of-concept studies have started, and in addition, Spago Nanomedical may also carry out phase 0 microdose trials with Tumorad®, where very small doses are used that can still be traced. This would get the agent into the clinic and generate pharmacokinetic data from humans at an early stage. The development of both SpagoPix and Tumorad® may dramatically change the way cancer diagnostics and treatments are conducted.


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Your LINK from innovation to market Considering the tremendous costs often related to product development within the life science industry, one would presume that a trusted partner in development is ever-present. This would most definitely be the case in the automotive industry, but is it also true for companies in life science?

Many companies – from the smallest biotech innovators to big pharma, often lack a sense of direction when it comes to costly product development projects. The common result is often a lot of time and money wasted. The most time-consuming projects are usually related to activities surrounding investigating issues that would never have arisen if the planning was right from the beginning. Therefore, partnering up with a CRO specialising in early development is a good idea. Full-service CRO

LINK Medical is a full-service CRO and is one of very few in Northern Europe to offer all-inclusive services from early devel-

opment through clinical phase, and on to market delivery. The company’s broad expertise strengthens each part of their portfolio. Early development expertise is essential for making the journey to market as efficient as possible. Moreover, experience in health economics and postmarketing projects is key to understanding the strategy required throughout the development process. Thus, thanks to the broad knowledge complex projects can be accelerated through the developmental stages to market. Saving time is not just saving money, in life science it is more than anything a matter of saving lives. First out: Germany and the United Kingdom

Just like any forward-striving company in any industry, LINK Medical is striving for constant development. After thousands of successful projects in Scandinavia, the company is now looking to expand across Northern Europe, starting with large economies such as Germany and the United Kingdom. “We have already started pur-

S T O C K H O L M

suing the German and British markets, and during 2020 we expect to have established full-service offices here as well. We are most definitely striving to become a trusted partner across Northern Europe,” says LINK Medical CEO Ola Gudmundsen. Becoming a European brand Both Germany and the United Kingdom are complex markets where many CROs operate. What LINK Medical can offer, as their competitive advantage, is a full understanding of the importance of early development and accurate planning at the very early stages. “Being a partner in the early development stages will often lead to an on-going collaboration, where LINK Medical together with the customer can bring the project closer to market much faster. We are already taking a leading role as trusted partner in projects involving several nations across Europe, what we need to do now is establish a name and brand that is not just Scandinavian but European,” states Ola Gudmundsen.

G O T H E N B U R G

O S L O

Facts and figures

LINK Medical has over 6,000 regulatory projects ongoing each year, and usually pursue over 250 early development clinical projects. With its 180 employees the company is one of Scandinavia’s largest CROs, with offices in Norway, Sweden and Denmark.

C O P E N H A G E N

LINK Medical is a Pan-European trusted partner, and offices in Germany and the United Kingdom have been established in order to bring the company closer to the markets in which it serves.

H E L S I N K I

Premium Full-Service CRO Global Reach and Local Expertise

Clinical Trials Pharmacovigilance Data Management

Patient Recruitment Services Non-Interventional Studies Quality Assurance Biostatistics

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COUNTRIES AND COMPANIES COMBATTING CANCER If a single disease were to be identified as” Public enemy number 1”, cancer would be a good candi...

Affärstidningen Näringsliv 3 2019  

COUNTRIES AND COMPANIES COMBATTING CANCER If a single disease were to be identified as” Public enemy number 1”, cancer would be a good candi...