[Updated, 8:45 am ET] Summer, it’s sad to say, is clearly in the rear-view mirror. No surprise, then, that biotech activity was flying this week. Partnerships, financings, data releases, IPO rumblings and more dot the news below:
—Cambridge, MA-based Genocea Biosciences revealed the first piece of clinical data it has collected to date, unveiling interim results from an early-stage clinical trial for a vaccine it is developing to treat genital herpes, called GEN-003. I spoke with CEO Chip Clark about the study, and how Genocea aims to show it can become the first company to create an effective vaccine for the chronic sexually transmitted disease.
—Weston, MA-based Biogen Idec (NASDAQ: BIIB) was this week’s most active biotech dealmaker. On Monday, it inked a deal with Carlsbad, CA-based Isis Pharmaceuticals (NASDAQ: ISIS) worth as much as $320 million as part of a six-year collaboration to develop neurology drugs. A day later, it turned around and partnered with Cranbury, NJ-based Amicus Therapeutics (NASDAQ: FOLD) on a preclinical program for Parkinson’s Disease.
—Shares of Cambridge-based OvaScience (NASDAQ: OVAS) plummeted 30 percent this week after the company revealed that the FDA wants it to conduct a series of clinical trials before it can seek regulatory approval for its lead product, Augment. Due to the FDA’s concerns, OvaScience suspended a U.S. trial testing Augment, a procedure designed to boost the success rate of in vitro fertilization.
—[Updated with new item] The fallout from Delcath Systems’ (NASDAQ: DCTH) FDA advisory panel debacle continued Friday as the Queensbury, NY-based company fired its CEO, Eamonn Hobbs, and revealed that the FDA has officially rejected Melblez, its drug-device combination treatment for cancer. The FDA wants Delcath to run another late-stage clinical trial before it approves the device. An advisory panel unanimously voted against Melblez in April, citing safety concerns.
—Long Island, NY-based Cold Spring Harbor Laboratory may be the former workplace of eight Nobel Prize Winners, but that doesn’t mean it can’t use some help commercializing its research. CSHL hired former venture capitalist Teri Willey to head its tech transfer office and lead what she calls a “proactive” business development approach. I talked to Willey about what she hopes to do for CSHL.
—Chelsea, MA-based Civitas Therapeutics got a second grant from the Michael J. Fox Foundation earlier this year, and followed that up this week with a $38 million Series B round of equity financing and some new investors, including RA Capital. Civitas, a spinout of Alkermes (NASDAQ: ALKS), is developing an inhalable version of long-used Parkinson’s disease drug levodopa.
—The Broad Institute of MIT and Harvard scored its latest industry partnership this week, as Bayer agreed to collaborate with the non-profit research group to find targeted cancer drugs. Broad has now signed three big partnerships over the past year. It recently put deals in place with AstraZeneca and Roche.
—Summit, NJ-based Celgene’s (NASDAQ: CELG) 2010 buyout of Abraxis Bioscience paid more dividends as the company won FDA approval of protein-bound paclitaxel (Abraxane)—which Celgene got when it acquired Abraxis—to treat patients with pancreatic cancer. That decision also triggers a $300 million payment from Celgene to those who invested in the contingent value rights, or CVRs, tied to the Abraxis deal.
—New York-based Ophthotech set the range for its coming IPO. The biotech plans to sell 5.7 million shares of its stock at between $16 and $19 apiece. It would raise about $100 million at the midpoint of its projected range. Ophthotech would trade on the Nasdaq under the symbol “OPHT.”
—Cambridge-based Foundation Medicine followed in kind. The cancer diagnostics company aims to raise about $75 million by offering 5 million shares at between $14 and $16 apiece at its coming IPO. Foundation aims to list on the Nasdaq under the symbol “FMI.”
—Waltham, MA-based Syndax Pharmaceuticals won a breakthrough therapy designation from the FDA for its experimental cancer drug, entinostat. That designation means the FDA will work more closely with the company than it otherwise would, to speed up the development of the product. I profiled Syndax a few weeks ago upon its latest capital raise.
—Cambridge-based Visterra, a startup developing an antibody designed to hit a molecular target used by all subtypes of the influenza A virus to infect cells, will begin its first clinical trial next year.
—New York-based Forest Laboratories (NYSE: FRX) finally named its successor for long-tenured, retiring CEO Howard Solomon this week. Ex-Bausch + Lomb head Brenton Saunders will take over as Forest’s president and CEO on Oct. 1.
—Cambridge-based Constellation Pharmaceuticals began its first clinical trial this week, putting epigenetic cancer drug CPI-0610 into a Phase 1 study testing it in patients with previously treated, progressive lymphomas. Constellation plans to begin studies of the drug in patients with acute leukemia and multiple myeloma as well.
—And don’t forget to join us at the Novartis Institutes for BioMedical Research in Cambridge on the evening of Oct. 2 for our latest East Coast biotech event, “Xconomy Xchange: Boston’s Life Science Disruptors.”