Biotechnology Focus July/August 2011

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R & D 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 com-

mercialization,” 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.

6 BIOTECHNOLOGY FOCUS JULY/AUGUST 2011

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 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.

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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.

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.

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