ReseaRch news

MaRS Innovation and GlaxoSmithKline partner to accelerate translational research

MaRS Innovation (MI) and GlaxoSmithKline Inc. (GSK) announce a new development fund (the GSK-MaRS Innovation Fund), that will support and fast-track the commercialization of some of the country’s most promising translational research coming from 16 leading academic health sciences centres, hospitals and universities derived from the MI membership.

“From the discovery of insulin in 1922 to the discovery of stem cells, Ontario has a rich, proud history of world-class medical and scientific breakthroughs. Our partnership with GSK Canada furthers Ontario’s position as a major international research hub by providing much needed capital to fund exciting drug discovery and development technologies and bridging the gap to successful commercialization,” said Rafi Hofstein, president and CEO for MaRS Innovation.

“The launch of this development fund is also part of a global trend where government, researchers and industry are partnering at the early stages of translational research with an eye to achieving global impact and improving patient care,” Hofstein added.

“GSK is proud to be working in collaboration with a leading partner in innovation research and development,” said Paul Lucas, president and CEO, GlaxoSmithKline Inc. “Collaborations such as these, where we share knowledge, expertise and resources, provide a highly effective way of progressing and commercializing cutting edge research. We hope that this collaboration will help to close the innovation gap in Canada.”

The GSK-MaRS Innovation Fund will support translational development projects with strong potential for commercialization in the following areas: drug development, diagnostics and healthcare delivery technologies. The strategic partnership will also provide access to capital and opportunities for early engagement with experts in drug development to guide and position technologies for successful commercialization through licensing transactions and/or start-up company creation. Representatives from MI and GSK will select projects for further development under this three-year partnership.

Sanofi Pasteur opens $100M R&D Centre in Canada

Sanofi Pasteur Limited has opened a new $101 million dollar vaccine research and development facility at Sanofi Pasteur’s Connaught Campus in north Toronto.

Mark Lievonen, president of Sanofi Pasteur commented at the opening held in June, “this new facility establishes the Connaught Campus as the North American Centre of Excellence in analytical and bioprocessing R&D for Sanofi Pasteur globally.”

He added that it solidifies the Toronto site as a national strategic asset for the research, development and manufacturing of vaccines that protect public health – in Canada and around the world.

The province of Ontario contributed $13.9 million to the project through the Biopharmaceutical Investment Program, part of the Next Generation of Jobs Fund. This investment helped retain a large vaccine R&D footprint in Ontario and will help secure future manufacturing jobs, since it is easier to reach commercial manufacturing scale for new products when R&D facilities are in close proximity to the actual manufacturing site.

“Sanofi Pasteur is a valued partner in our commitment to health care in Ontario,” said Premier Dalton McGuinty at the opening. “This impressive new building houses some of the most Continued on page 9

Clinical Trials & Patents

n Resverlogix Corp. (Calgary, AB) has completed its chronic repeated-dose toxicology studies on its lead compound, RVX-208, indicated for the reduction and prevention of atherosclerosis. These chronic toxicology studies support the initiation of its longer duration, Phase 2b, clinical trial ASSURE. As a first-in-class compound, RVX-208 underwent six and twelve month testing in rodents and non-rodents, respectively, and the analysis, results and reporting of these studies to the appropriate regulatory authorities, have been completed. With the safety studies complete, RVX-208 can now advance into trials of more than three months duration. The Phase 2b ASSURE trial, in which Intra Vascular Ultra Sound (IVUS) technology will be used to determine coronary arterial plaque regression, will have a treatment duration of six months. The IVUS measurement will be used as the trial’s primary endpoint.

n Medicago Inc. (Québec, QC) reports positive results from a U.S. Phase 1 human clinical trial with its seasonal influenza vaccine candidate. All vaccine doses were found to be safe, well tolerated and also induced a solid immune response. A total of 100 healthy volunteers between the ages 18 to 49 received one of the following; a single non-adjuvanted dose of Medicago’s H1N1 vaccine at varying doses (5ug, 13ug, 28ug), an injection of the placebo or an H1N1 vaccine from a licensed trivalent vaccine. No serious adverse events were reported during the trial and the vaccine was found to be well tolerated at all three dosage levels. Based on these results and subject to regulatory approval, Medicago intends to proceed with a U.S. Phase 2a trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains.

n DiagnoCure, Inc. (Québec, QC) reports the issuance of a new U.S. patent, and addition to DiagnoCure’s PCA3 prostate cancer biomarker portfolio. In addition to providing greater patent protection, this new patent bears an extended expiration date that lengthens by 20 months the term of the license that DiagnoCure granted to its commercial partner, GenProbe. This new U.S. patent, 7,960,109 “mRNA Ratios in Urinary Sediments and/or Urine as a Prognostic and/or Theranostic Marker for Prostate Cancer”, covers the particularities of the quantitative urinary test developed by GenProbe. This test allows the determination of a PCA3 score in urine following a digital rectal examination and indicates the probability of finding cancer in a prostate biopsy by associating a higher score with a greater probability of a positive biopsy, with a much greater precision than the traditional PSA test. The term of the license agreement with Gen-Probe is tied to the last-to-expire licensed patents. As a result, since this is now the patent with the latest expiration date, the duration of the Gen-Probe license will be extended to August 2027.

Rising stars in global health

Left to Right: Dr. Tore Godal, Gary Darmstadt, Tamar Manuelyan Atinc, Dr. John P. Holdren, Ms. Melinda Gates, Secretary Clinton, Dr. Peter A. Singer, Administrator Shah

Grand Challenges Canada has announced 19 grants to Canadian innovators in the fi rst phase of its Canadian Rising Stars in Global Health initiative. Grand Challenges Canada is a new global health organization funded by Canada’s foreign aid budget. Its purpose is to fund research to address some of the most diffi cult global health issues through Integrated Innovation and save lives. Canada is the fi rst country in the world to adopt a grand challenges approach to foreign aid.

Grand Challenges Canada participates in a consortium with Canada’s International Development Research Centre (IDRC) and the Canadian Institutes of Health Research (CIHR). Mr. David Malone, president of IDRC, joined Dr. Alain Beaudet, president of CIHR in congratulating the new grantees. “The grant recipients have all displayed enormous creativity and commitment to solving global health challenges,” said Dr. Beaudet. “It is exciting and very rewarding to have the opportunity to encourage them in their work.” David Malone adds, “we’re very pleased to see Grand Challenges Canada, Canada’s International Development Research Centre and the Canadian Institutes of Health Research take a ‘whole of Canada’ approach to creating the Canadian Rising Stars in Global Health initiative and supporting Canadians’ contribution to global health.”

In a fi rst for a Canadian grant application process, the innovators each produced a short video to explain their ideas to Canadians. Through a rigorous peer review process, 19 innovators’ proposals were selected from across Canada each receiving a grant of $100,000. There will be three rounds of Canadian Rising Stars for a total of $20 million. Of this amount, approximately $14 million will be available for scale-up grants.

From a tattoo that delivers drugs to combat a debilitating and disfi guring disease; to solar powered tablets to train women in Haiti on HIV prevention; to a rugged, reliable fetal heart monitor that doesn’t require electricity in order to save babies’ lives in Africa, Canadian innovators demonstrate creativity, bold ideas and big hearts in the quest to make a difference in the developing world and save lives.

Should their ideas be found robust, effective, and proven, the innovators will be eligible for an additional scale–up grant of up to $1 million for each proposal.

“When I ran the in the Olympic Torch Relay with my wife Sandra, we felt a sense of pride in Canada as we had never felt before,” says Joseph L. Rotman, Chair of Grand Challenges Canada. “I feel the same sense of pride about these outstanding Canadian Rising Stars in Global Health who demonstrate the leadership Canadians can and do contribute to the international community.”

Says Dr. Peter A. Singer, chief executive offi cer of Grand Challenges Canada: “These innovators are dedicated to bringing change to the world’s poorest countries. They believe Canada has a leadership role in improving health conditions in the developing world. Collectively they are a source of pride for our country.”

Grand Challenges Canada is now sending a request for proposals for round two of Canadian Rising Stars in Global Health. In this round, proposal submissions will require developing world innovators to collaborate with Canadians on their bold ideas.

For more information please visit www. grandchallenges.ca

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AlgaeBio to enter nutraceuticals market with ultra-pure omega-3 fatty acid oils

It’s pure and simple. Canada’s new player in the algae industry is gearing up for its debut in the nutraceutical and food additive markets.

Algae Biosciences Corporation, a Canadian public biotechnology company, began trading on the TSX Venture Exchange in early May. AlgaeBio’s production facilities near Holbrook, Ariz., are being expanded to reach large-scale commercial production levels before year’s end and the first order of business for the company will be ramping up the manufacture of ultra-pure omega-3 fatty acid oils.

Already, AlgaeBio is receiving extremely positive interest in its omega-3 product line, and is currently exploring international distribution channels.

According to scientific studies, omega-3 fatty acids improve heart joint, and brain health, may be linked to lower diabetes risk, and are beneficial to cognitive functioning and development, especially for infants and children. Preliminary studies also suggest that the essential unsaturated fatty acids may be beneficial in treating depression while reducing the risk of breast cancer, colon cancer, prostate cancer and strokes.

Omega-3 is currently used in such food staples as bread, milk, yogurt, juice, breakfast cereal, spreadable oils, and infant formula. Currently, market demand for omega-3 fatty acid oils overwhelmingly exceeds industry production capacity, and premium prices are paid for the purest algae-based ingredients in food and nutritional products.

AlgaeBio has the potential to produce algae in an ultra-pure form, on a large scale and at a low cost.

AlgaeBio produces omega-3 products that contain both EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) — essential fatty acids that cannot be produced by the human body — while the vast majority of competing products contain only DHA. And because AlgaeBio’s omega-3 products are plant-based, there’s none of the concern about potential environmental pollutants and contaminants that surrounds marine sources of omega-3, such as fish oil.

Agricultural research celebrating Its roots

Saskatchewan and Manitoba to Partner on Bi-Provincial Innovation and Research Opportunities

What do Marquis wheat, blueberry juice and a reusable shipping container have in common? They were all developed at Agriculture and Agri-Food Canada (AAFC) research stations. AAFC celebrated an exciting milestone in Canadian agriculture history, as the month of June marked the 125th anniversary of the creation of the first agriculture research farms in Canada.

In June 1886, Parliament passed the Experimental Farm Station Act and created five research farms charged with conducting agriculture research to benefit Canadian farmers: Agassiz, British Columbia; Indian Head, Saskatchewan; Brandon, Manitoba; Ottawa, Ontario; and Nappan, Nova Scotia.

AAFC research began by developing new crop varieties suitable for Canadian climates to allow early settlers to cultivate their new land. Over the years, research produced significant new developments including canola, wheat varieties that resist rust, hardy soybeans, technology to process fruit and DNA analysis for early disease detection in plants.

Today, AAFC has a network of research centres and stations across the country with 2,100 employees, including 500 researchers who work closely with farmers and the agriculture sector. AAFC scientists continue to find innovative ways to grow healthy, profitable foods with less impact on our environment. Scientific achievements have helped boost the farm gate for Canadian farmers. Canadian agriculture products are exported worldwide, and the agri-food sector is now the leading manufacturing employer in the country.

For more information on events taking place across the country to celebrate 125 years of agricultural research, please visit www.agr.gc.ca/scienceandinnovation. The Provinces of Saskatchewan and Manitoba signed a Letter of Intent (LOI) to cooperate on research and innovation initiatives at the BIO International Convention in Washington, DC. The LOI recognizes the two provinces’ history of cooperation in areas such as electricity, transportation and emergency response, and focuses on key priority areas of mutual interest in the research and innovation areas: • Crop agriculture • Bioenergy, bioproducts and environment • Human and animal health.

The Life Science Association of Manitoba (LSAM) and Ag-West Bio Inc., the biotechnology sector membership organizations in both provinces, applaud the nature of the LOI.

“We work very closely with organizations in the sector in Manitoba and have a reciprocal agreement with Ag-West Bio in Saskatchewan. Having the Provinces officially state their commitment to working together in the biotech sector is a very positive step forward,” said Tracey Maconachie, president of LSAM.

A Bi-Provincial Genomics Innovation Summit was organized by Genome Prairie and held in Winnipeg in October of 2010. The event was well attended and supported by the Governments of Saskatchewan and Manitoba, industry and academic representatives. The discussions focused on key bi-provincial priority areas, all of which appeared in the LOI.

Allon Therapeutics wins early stage company of the year

BIOTECanada announces that Allon Therapeutics Inc. is this year’s Gold Leaf Award Early Stage Company of the Year winner.

BIOTECanada said Allon was chosen as the top pre-commercialization company in the Canadian biotechnology healthcare sector “by distinguishing themselves from their peers with demonstrated technology innovation and achieved milestones.”

Gordon McCauley, Allon’s president and CEO, said the prestigious Gold Leaf Award recognizes the company’s clinical trial successes and progress toward commercializing products in devastating degenerative brain diseases, such as Alzheimer’s, Parkinson’s and several types of frontotemporal dementia.

“Being chosen as Canada’s leading precommercial healthcare biotech company is a great honour and an enormous compliment to the dedication, innovation, and excellence demonstrated by our team every day,” said McCauley. “It is also important recognition of the investigators, patients, and caregivers we partner with to find solutions to these awful diseases.” Gordon McCauley receives the award for Best Early-Stage Biotechnology Company - Health, presented by Patricia Massetti, Executive director of Merck Canada. Photo: Allon Therapeutics

Allon announced last month it had successfully enrolled 50 per cent of its 300-patient objective in a pivotal clinical trial evaluating lead drug candidate davunetide as a treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease. The company is on track to complete enrolment by the end of 2011 and to report data approximately one year later.

The pivotal trial is being conducted under a Special Protocol Assessment granted by the United States Food and Drug Administration (FDA), which means that the agreed clinical trial design meets the FDA’s expectations for a pivotal study. Designation of davunetide for PSP as an orphan drug in the U.S. and the European Union brings significant commercial incentives for the company.

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exciting talent anywhere, doing some of the most vital research in the world. We congratulate Sanofi Pasteur and look forward to new breakthroughs and new jobs.”

a national strategic asset The new R&D facility, known internally as “Building 95”, will help the company retain over 300 highly-skilled vaccine research positions and bring many of the company’s accomplished scientists and state-of-the-art technologies under one roof. In fact, the North American Centre of Excellence designation means the critical mass of scientific expertise at Connaught Campus is playing a lead role in advancing Sanofi Pasteur’s global vaccine pipeline.

The Toronto site manufactures many vaccines vital to public health with 94 per cent of its vaccine production being delivered to over 90 countries around the world. In fact, over 20 per cent of global sales at Sanofi Pasteur, the world’s largest vaccine company, are generated by vaccines manufactured at the Connaught Campus. Its strategic positions include: • The only manufacturer of 5-component acellular pertussis combination vaccines globally • The only manufacturer of polio (IPV) vaccine in the Americas • The only Canadian manufacturer of diphtheria and tetanus vaccines • The capacity to stockpile paediatric vaccines domestically to ensure security of supply for Canadian immunization programs In all, the company employs over 1,100 people at the Connaught Campus, including 300 in R&D and over 700 in highly-technical vaccine manufacturing jobs.

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