Advancing Drugs at Roche, Sophiris, Coherus, and Other Bio News

Xconomy San Diego — 

An economic impact report released this week by the California Life Sciences Association found that life sciences companies in the Golden State currently have 1,235 new drugs in the development pipeline—and it seemed like this week there was news on each one. Here’s our wrap of the life sciences news from the West Coast

—The FDA approved cobimetinib (Cotellic), which was first developed by South San Francisco, CA-based Exelixis (NASDAQ: [[ticker: EXEL]]) before Genentech, now part of Roche, bought much of the rights and took it through late-stage clinical trials for advanced melanoma. It was approved as a combination therapy with Genentech’s vemurafinib (Zelboraf). The expected approval is a big step back for Exelixis, as we wrote about in August. The biotech will split cobimetinib profits with Genentech.

—In a reversal of fortune, San Diego-based Sophiris Bio (NASDAQ: SPHS said topsalysin, its biologic drug for treating an enlarged prostate, met the primary goal of a 52-week clinical trial by showing a significant improvement in patient symptoms that include frequent or difficult urination. The results sent shares of Sophiris soaring—roughly 11 months after the stock tanked after Sophiris reported interim results (three months into the trial) that failed to show effectiveness.

Amplyx Pharmaceuticals said it closed on $40.5 million in Series B financing, and plans to use the capital to advance development of APX001, a new anti-fungal compound for treating life-threatening fungal infections. RiverVest Venture Partners led the round, which included NEA, BioMed Ventures, and individual investors. Amplyx intends to take advantage of incentives created as part of the GAIN Act of 2012.

—One of the rare small or modestly sized firms working on biosimilars hit a clinical milestone, too. Coherus BioSciences (NASDAQ: CHRS) of Redwood City, CA, and its development partner Baxalta (NYSE: BXLT) announced positive Phase 3 data for their biosimilar based on etanercept (Enbrel). It remains to be seen, however, if the wave of biosimilars heading toward market will make a noticeable dent in the staggering cost of U.S. healthcare.

—Amgen is also working on biosimilars, and its copycat version of adalimumab (Humira), the world’s top-selling drug, posted good Phase 3 results this week.

—San Diego’s Avalon Ventures formed Iron Horse Therapeutics, a new biotech with a promising new drug candidate for treating amyotrophic lateral sclerosis (ALS), a neuro-degenerative disease also known as Lou Gehrig’s disease. (The Hall of Fame baseball player’s nickname was “the Iron Horse.”) Iron Horse is the seventh life sciences startup that Avalon has founded through its GSK collaboration, which has worked so well that Avalon and GSK are extending their partnership agreement.

—Immune Design (NASDAQ: IMDZ) of Seattle and South San Francisco, CA, reported this week the kickoff of a Phase 2 trial for its cancer immunotherapy booster, CMB305. The drug is being tested in patients with soft tissue sarcoma in combination with Genentech’s atezolizumab, an anti-PDL1 checkpoint inhibitor.

Promising Phase 3 results for the lead drug candidate from Portola Pharmaceuticals (NASDAQ: PTLA) of South San Francisco were published Wednesday in the New England Journal of Medicine. The drug is a reversal agent, given to patients who have received an anti-coagulant that causes major bleeding.

—Bad news continued to hit Palo Alto, CA-based Theranos, the high-profile startup looking to make blood tests widely available in storefronts. According to the Wall Street Journal, the supermarket chain Safeway signed on in 2011 to be the exclusive supermarket provider of Theranos tests but has backed away from the $350 million deal, and the two sides are looking to unwind the partnership.

—Cytokinetics (NASDAQ: CYTK) and its development partner Amgen (NASDAQ: AMGN) said Sunday at an American Heart Association meeting that their experimental heart failure drug omecamtiv mecarbil demonstrated positive Phase 2 results, but they did not say whether they would move the drug into a larger Phase 3 trial, according to Reuters.

—San Diego-based Ignyta (NASDAQ: RXDX) said it has licensed the anti-cancer drug taladegib from Eli Lilly for $2 million and about 1.2 million shares of Ignyta’s common stock. Lilly also agreed to make a concurrent $30 million investment in Ignyta. Lilly retained certain rights to commercialize taladegib in combination with other Lilly compounds.

—San Diego’s aTyr Pharma (NASDAQ: LIFE) said it has selected a second investigational new drug candidate from its catalog of physiocrines, naturally occurring proteins that appear to restore stressed or diseased tissue to a healthier state. The company said the selected molecule is intended to help patients with severe pulmonary diseases with an immune and fibrotic component. aTyr has designated its lead drug candidate, Resolaris, for the treatment of rare myopathies with an immune component (RMICs), such as facioscapulohumeral muscular dystrophy (FSHD).

—The New York Times Magazine ran a profile of University of California, Berkeley scientist Jennifer Doudna, a CRISPR-Cas9 gene editing pioneer.

—Google and the American Heart Association announced a $50 million grant, with each group contributing half, that will go to a single research team, as described by AHA CEO Nancy Brown in a blog post.

Xconomy National Biotech Editor Alex Lash contributed to this roundup.