This week’s roundup has an elevation change. In San Diego, Orexigen Therapeutics, maker of a weight-loss drug, dug itself deep into a hole with the FDA, its clinical collaborators, and its business partners. In San Francisco, Denali Therapeutics debuted with a mountain of cash to tackle neurodegenerative diseases.
L.A. billionaire and partial Laker owner Patrick Soon-Shiong’s NantWorks biomedical empire was in the news, and there were drips and drabs of data from West Coast companies among the flood of abstracts released in advance of the annual American Society for Clinical Oncology meeting later this month. I also spent time examining the next big hurdles for cancer immunotherapy in my column this week, with Juno Therapeutics and other West Coast companies in the mix. Time to round it all up.
—Shares of San Diego’s Orexigen Therapeutics (NASDAQ: [[ticker:OREX]]) slumped more than 15 percent Wednesday over more fallout from a long-term study the FDA required after it approved Contrave, the company’s weight-loss drug, last year. The study aimed to assess whether patients taking Contrave faced a higher risk of serious heart problems. In March, Orexigen prematurely released early results of the study, and the data appeared to show that Contrave might reduce cardiovascular risks. On Tuesday Orexigen said it had terminated the study early and now plans to conduct a new trial. The company’s conduct triggered withering criticism from Steve Nissen, the cardiologist overseeing the study, as well as a deep dispute with Takeda, Orexigen’s strategic partner.
—Three Genentech alumni launched Denali Therapeutics in South San Francisco, CA, with $217 million in venture funding to develop treatments for Alzheimer’s, Parkinson’s, and other neurodegenerative diseases. Arch Venture Partners, Flagship Ventures, Fidelity Biosciences, the Alaska Permanent Fund and others are behind the financing.
—ASCO: Puma Biotechnology (NYSE: [[ticker:PYBI]]) of Los Angeles saw shares fall almost 19 percent Thursday after abstract data revealed little difference between its breast cancer treatment neratinib and other treatments, as well as a high rate of serious diarrhea among trial participants. Puma chief Alan Auerbach told Forbes that problems with genetic testing of trial participants skewed the data.
—ASCO: Roche division Genentech of South San Francisco, CA, released interim Phase 2 data that its checkpoint inhibitor MPDL3280A doubled the likelihood of survival in non-small-cell lung cancer patients, compared to patients taking chemotherapy. The increased survival was correlated with patients whose cancer had high levels of the protein PD-L1, which MPDL3280A targets. The FDA has granted the drug a breakthrough designation.
—Patrick Soon-Shiong’s NantPharma is buying the cancer drug Cynviloq for $90 million upfront from Sorrento Therapeutics of San Diego (NASDAQ: [[ticker:SRNE]]), and potential payments could total more than $1 billion. Sorrento has partnered with other parts of Soon-Shiong’s NantWorks conglomerate before. One of those parts, NantBioScience, apparently has raised $100 million recently, according to an SEC filing first spotted by MedCityNews.
—Juno Therapeutics (NASDAQ: [[ticker:JUNO]]) of Seattle bought 23-person German biotech Stage Cell Therapeutics for €52.5 million (about $59 million) in cash and 486,279 shares of Juno stock. Juno could pay up to €270 million ($308 million) more in milestone payments.
—Trade groups BayBio and the California Healthcare Institute consummated their merger, launching the California Life Sciences Association this week.
—Vaccine firm PaxVax of Redwood City, CA, said that president and COO Nima Farzan will take over as CEO. He is replacing cofounder Kenneth Kelley, who will remain a director.
—San Diego-based Organovo (NASDAQ: [[ticker:ONVO]]) has signed an agreement with the U.S. subsidiary of the French cosmetics giant L’Oreal to develop 3D-printed skin tissue to use as an alternative to animal testing of skin care products.
—Alder Biotherapeutics of Seattle released Phase 2 data for its migraine treatment, ALD403, that showed 16 percent of patients taking the drug were migraine-free for three months and 11 percent for six months. No one taking placebo was migraine-free over those periods. The company said it would run two trials in the second half of 2015 to find the right doses for the drug.
—U.S. senator and presidential hopeful Bernie Sanders (Ind-VT) asked the Department of Veterans Affairs to use emergency measures to break patents and lower the prices Gilead Sciences (NADSAQ: [[ticker:GILD]]) and AbbVie (NYSE: [[ticker:ABBV])) charge for their hepatitis C drugs.
—Aspyrian Therapeutics of San Diego, which uses near-infrared light to activate an immune response targeting certain types of tumors, said it has the FDA’s green light to begin the first clinical studies of its lead candidate, RM-1929. The drug is a light-activated antibody-drug conjugate that aims to treat recurrent head and neck cancer.
—San Francisco’s IndieBio accelerator said it would bump the amount of seed funding it provides to its participants to $250,000 per company.
—Xconomy San Diego editor Bruce Bigelow contributed to this report.
—Featured photo “Santa Cruz surfing” courtesy of Wonderlane via a Creative Commons license.
