Oncothyreon Inc.'s detailed results for its cancer immunotherapy product L-BLP25 (formerly Stimuvax), reported at the meeting of the American Society of Clinical Oncology Annual Meeting in Chicago, failed to comfort nervous investors. Having previously missed its primary endpoint of overall survival (OS) in non-small-cell lung cancer, the company said that median OS was 25.6 months compared to 22.3 months for the placebo group, with a "p" value of 0.123. A post hoc analysis in a subgroup of 806
By Catherine Shaffer | BioWorld Today | Friday, May 17, 2013
Amgen Inc., of Thousand Oaks, Calif., reported findings from analyses of Vectibix (panitumumab) in combination with Folfox, an oxaliplatin-based chemotherapy regimen, as first-line treatment in metastatic colorectal cancer (mCRC). The analyses included the description of new predictive biomarkers of clinical response to Vectibix, activating mutations in KRAS (beyond exon 2) and in NRAS, collectively referred to as RAS. The RAS biomarkers were identified in a predefined retrospective subset
MedImmune Inc., part of AstraZeneca plc, started the first patient in its Phase III hairy-cell leukemia (HCL) trial with its first-in-class antibody-drug conjugate moxetumomab pasudotox (MP), a CD22 immunotoxin made up of an anti-CD22 antibody fused to a toxin. The molecule binds to CD22, gets internalized and processed, and then releases the toxin payload to blast the tumor. MP looked promising in Phase I, with a manageable safety profile, which led London-based AstraZeneca to make the
By Randy Osborne | BioWorld Today | Friday, May 17, 2013
AnaptysBio Inc., of San Diego, disclosed a contract award from the U.S. government for the development of highly thermostable anti-ricin antibodies for biodefense applications. Under the terms of AnaptysBio's contract with the Science and Technology Corp., AnaptysBio will be responsible for delivering anti-ricin antibodies to the Edgewood Chemical and Biological Center, an agency of the U.S. Army. The contract is funded by the Defense Threat Reduction Agency, and follows successful completion
Like the troll of yore demanding his pound of goat flesh as the toll for using his bridge, patent trolls are threatening to swallow up biotech start-ups – just as they have other businesses that strayed too close to the vague boundary lines of their intellectual property. So far, patent trolls, also known as patent licensing companies, haven't gotten too gruff with drug- and devicemakers, but it looks like that could change, Jeff Grainger, managing partner of the Foundry LLC, a medical device
By Mari Serebrov | BioWorld Today | Friday, May 17, 2013
TAIPEI, Taiwan – In what is likely one of the first attempts by a foreign biopharma to complete the full range of clinical trials in China for a new biologic, leading to regulatory and market approval by Chinese drug approval authorities, therapeutic antibodies specialist RuiYi Inc., of La Jolla, Calif., and Shanghai, entered a collaboration agreement with Genor BioPharma Co. Ltd., of Shanghai, to develop its anti-IL-6 monoclonal antibody RYI-008 for rheumatoid arthritis (RA). The deal
By Dave Silver | BioWorld Today | Friday, May 17, 2013
Despite losing a potentially lucrative FLT3 inhibitor partnership with Astellas Pharma Inc. barely two months ago, Ambit Biosciences Corp. forged ahead with its initial public offering (IPO). The San Diego-based biotech priced about 8.1 million shares at $8 apiece for gross proceeds of about $65 million. The pricing came in lower than Ambit had hoped – it set a $13 to $15 price range earlier this month – but the firm increased the number of shares offered to make up the difference. Proceeds
By Jennifer Boggs | BioWorld Today | Friday, May 17, 2013
Bayer AG, of Leverkusen, Germany, signed an agreement to acquire the shares of Steigerwald Arzneimittelwerk GmbH, of Darmstadt, Germany, a privately held pharmaceutical company specializing in pharmacy-only herbal medicines. Steigerwald's product portfolio includes Iberogast for the treatment of functional gastrointestinal disorders and Laif for the treatment of mild to moderate depression. Financial details were not disclosed, but Steigerwald generated 2012 sales of €61.3 million (US$79
Common stock in Fibrocell Science Inc., of Exton, Pa., has been approved for listing on the NYSE Market, to commence trading on May 17, under the ticker symbol FCSC. The FDA approved Tarceva (erlotinib) tablets for first-line treatment of metastatic non-small-cell lung cancer characterized by tumors with epidermal growth factor receptor-activating mutations. The product is marketed by Genentech Inc., a member of the Basel, Switzerland-based Roche Group, and Astellas Pharma Inc., of Tokyo. In
Merck Serono SA, of Rockland, Mass., a division of Merck KGaA, of Darmstadt, Germany, and Quintiles Inc., of Research Triangle Park, N.C., signed a new, five-year clinical development agreement. Under the agreement, Quintiles will direct clinical trial planning and execution of trials guided by Merck Serono's strategy. Quintiles will also contribute to Merck Serono's future trial design process. The two companies will share decision-making responsibility for the Merck Serono portfolio. Mylan
The pulse of the National Institutes of Health (NIH) could weaken without a healthy injection of money to fund future innovations and the scientists who form the core of biomedical research. "This is a perilous moment" for both the NIH and the future of innovative research, NIH Director Francis Collins told a Senate Appropriations subcommittee Wednesday as he pushed for more funding for the agency. NIH has lost 22 percent of its purchasing power over the past decade, and the number of grants it
By Mari Serebrov | BioWorld Today | Thursday, May 16, 2013
Embryonic stem cells have been the subject of so many political fights that it's easy to forget they have also faced formidable scientific obstacles. But they have. Human eggs, it turns out, are far more fragile than those of most other mammals – including those of other primates. And so, methods that have been used to clone mammals from Dolly the sheep to Snuppy, the cloned dog that was South Korean stem cell scientist Woo-Suk Hwang's only non-fraudulent claim to fame, have failed to produce
By Anette Breindl and Nuala Moran | BioWorld Today | Thursday, May 16, 2013
Bayer HealthCare Pharmaceuticals Inc., of Berkeley, Calif., and Onyx Pharmaceuticals Inc., of South San Francisco, said the FDA approved Bayer's Stivarga (regorafenib) for metastatic gastrointestinal stromal tumor previously treated with imatinib mesylate and sunitinib malate. Stivarga was previously approved for metastatic colorectal cancer. Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., enrolled their first patients in Phase III COMPARE and ASCERTAIN trials of
Jennerex Biotherapeutics Inc., of San Francisco, said data demonstrating the ability of its lead product candidate, Pexa-Vec (JX-594, pexastimogene devacirepvec) to induce functional anticancer immunity, both in patients with diverse solid tumor types and in animal models has been published in the May 15 issue of Science Translational Medicine. The paper described findings from a Phase I study evaluating the safety and efficacy of Pexa-Vec after an intratumoral administration in patients with
The American Society of Clinical Oncology (ASCO) released the first of more than 4,700 abstracts late Wednesday in anticipation of its 2013 annual meeting, scheduled to attract more than 30,000 participants to Chicago from May 31 to June 4. Early abstracts highlighted by ASCO at a Wednesday afternoon press conference suggested a significant focus this year will be advances in cancer immunotherapies, including inhibitors of PD-L1 and PD-1. Roy S. Herbst, professor of medicine at Yale University
By Marie Powers | BioWorld Today | Thursday, May 16, 2013
Algeta ASA and partner Bayer AG disclosed FDA approval Wednesday for Xofigo (radium Ra 223 dichloride) in castration-resistant prostate cancer, with the agency's nod coming three months ahead of the Aug. 14 PDUFA date. Xofigo, an alpha particle-emitting radioactive therapeutic agent, was approved based on data showing that the drug produced an overall survival benefit with antitumor effects on bone metastases. "We're actually delighted," Algeta CEO Andrew Kay told BioWorld Today. "This is a
By Catherine Shaffer | BioWorld Today | Thursday, May 16, 2013
Development of Tokai Pharmaceuticals Inc.'s triple-acting prostate cancer drug galeterone got a $35.5 million boost, with the Cambridge, Mass.-based biotech closing a Series E round with current investors Apple Tree Partners and Novartis Venture Funds, as well as undisclosed angel investors. Proceeds will go toward expanding the ongoing Phase II ARMOR2 study into patients with castration-resistant prostate cancer (CRPC) and preparing for registrational trials. The company could not be reached
By Jennifer Boggs | BioWorld Today | Thursday, May 16, 2013
Gradalis Inc.'s interim Phase II data with its personalized cancer vaccine for advanced ovarian cancer showed the approach more than doubled the benefit in patients given therapy known as FANG, a rough acronym for "furin and granulocyte-macrophage colony-stimulating factor (GMCSF)." The trial, which has enrolled 17, treated 12 with FANG plus standard treatment and five with only the standard treatment, which consists of surgery and chemotherapy, with an eye on the primary endpoint of time to
By Randy Osborne | BioWorld Today | Thursday, May 16, 2013
Oncothyreon Inc.'s detailed results for its cancer immunotherapy product L-BLP25 (formerly Stimuvax), reported at the meeting of the American Society of Clinical Oncology Annual Meeting in Chicago, failed to comfort nervous investors. Having previously missed its primary endpoint of overall survival (OS) in non-small-cell lung cancer, the company said that median OS was 25.6 months compared to 22.3 months for the placebo group, with a "p" value of 0.123. A post hoc analysis in a subgroup of 806