More handwringing from investors this week as the Nasdaq Biotechnology Index (NASDAQ: [[ticker:IBB]]) continued falling, and new entrants to the market had to lower their expectations to make a debut. It wasn’t all bad in biotech, however. This week’s roundup below.
—Amid a dismal week for biotech stocks, Cambridge, MA-based Agios Pharmaceuticals (NASDAQ: [[ticker:AGIO]]) was the sector’s big winner. Agios released its first human clinical data at the American Association of Cancer Research’s annual meeting, and while it’s a small, early sample size—Agios reported on just seven patients with acute myeloid leukemia taking its lead drug, AG-221—the results were enough to send the company’s shares up more than 36 percent. Agios immediately cashed in, announcing plans to raise up to $75 million through a stock offering.
—Alarm bells are always going off about the dearth of new antibiotics. Cambridge-based Spero Therapeutics, Atlas Venture’s new seedling startup, says it’s bringing a new approach to fight tough-to-kill bugs. Spero emerged from stealth this week with $3 million in backing from Atlas, SR One, and Partners Innovation Fund. Roche, the big Swiss drugmaker, has also got an option to acquire Spero’s lead program once the startup has all the data ready to submit an investigational new drug application with the FDA. I spoke with Spero president and Atlas Venture partner Ankit Mahadevia about the company’s plan to switch off bacteria, rather than kill them.
—Perhaps Cerulean Pharma (NASDAQ: [[ticker:CERU]]) simply picked the wrong week to go public. Or perhaps investors just weren’t willing to give its nanoparticle drug delivery technology another shot after it flunked a clinical trial last year. Either way, the Cambridge-based company had to cut its IPO price to $7 (from a projected $11 to $13 per share), and closed its first day of trading down another 2 percent, at $6.85 per share. Cerulean sold 8.5 million shares in the offering, instead of the 5 million originally projected. It will use the cash to push through ongoing clinical trials of CRLX-101, a cyclodextrin-based polymer linked to a chemotherapy drug, in kidney, rectal, and ovarian cancer.
—Multiple reports this past week from Forbes, FierceBiotech, OncLive, and others indicated that New York’s Memorial Sloan Kettering Cancer Center temporarily suspended a trial testing Seattle-based Juno Therapeutics’ prospective cancer therapy because two patients in the trial died. OncLive reported on Wednesday, however, that the trial is expected to be up and running again in the next 7 to 10 days. One of the study’s investigators told the publication that there’s no direct evidence that Juno’s treatment—which involves isolating T cells from a patient’s blood, re-engineering them into cancer killers, and infusing them back into the body—are to blame for the deaths, but that researchers are amending the trial to curb risk.
—Dublin and Waltham, MA-based Alkermes (NASDAQ: [[ticker:ALKS]]) reported positive top-line results from a Phase 3 trial of aripiprazole lauroxil, a long-acting injectable form of Bristol-Myers Squibb’s blockbuster schizophrenia drug aripiprazole (Abilify). Alkermes plans to file a new drug application with the FDA in the third quarter, setting up the company—traditionally known as using its drug delivery technology to boost drugs made by others in exchange for royalties—with a potentially big revenue stream of its own.
—Cambridge-based Mersana Therapeutics found its latest partner, inking a deal with Japan’s Takeda Pharmaceutical for its antibody-drug conjugate technology. Mersana didn’t reveal the numbers involved, but it’s getting an upfront payment from Takeda to tap into the ADC platform, and stands to receive milestones and royalty payments should potential drugs from the partnership progress. Mersana already has drug development deals in place with Teva Pharmaceuticals (NYSE: [[ticker:TEVA]]) and Endo Pharmaceuticals (NASDAQ: [[ticker:ENDP]]).
—Eleven-year-old cancer drug company Deciphera is moving from Lawrence, KS, to Boston led by a new president and CEO, Mike Taylor—last seen heading up Cambridge-based Ensemble Therapeutics. Deciphera also got a $6 million milestone payment from Eli Lilly (NYSE: [[ticker:LLY]]) for taking the experimental cancer drug it’s developing with the Indianapolis drugmaker into a Phase 1 clinical trial.
—New York-based Health tech accelerator Startup Health announced the 16 newest members of its Startup Health Academy, an entrepreneurship program designed to help shepherd companies through early development. Startup Health has put 63 nascent companies through its program. So far, three of them—most recently Basis Science—have been acquired.
—Roche agreed to snap up Marlborough, MA-based iQuum for $275 million up front, and potentially another $175 million in milestone payments. iQuum is a diagnostics startup with a “Laboratory in a tube” system, which the company says supposedly enables clinicians in hospitals to quickly perform molecular diagnostic tests—in 20 minutes to an hour— with little training.
—Undaunted by the FDA’s decision to reject multiple sclerosis drug alemtuzumab (Lemtrada) in December, Sanofi and its Cambridge-based Genzyme unit are heading back to U.S. regulators once again. Genzyme said this week that following “constructive” talks with the FDA, it has resubmitted another application for the drug to the agency. Alemtuzumab is already approved in 30 countries, but the FDA questioned the company’s trial design and cited certain potentially serious side effects when turning the drug away from the U.S. market last year.
—A few weeks after the FDA approved its hemophilia B treatment, Cambridge-based Biogen Idec (NASDAQ: [[ticker:BIIB]]) posted positive Phase 3 results testing its prospective long-lasting hemophilia A drug, Eloctate, in children under 12. Biogen is developing both drugs with the help of Stockholm-based Swedish Orphan Biovitrum.
—Basking Ridge, NJ-based Regado Biosciences (NASDAQ: [[ticker:RGDO]]) priced a secondary stock offering of 10 million shares at $6 apiece, raising $60 million. Regado shares plummeted about 18 percent in pre-market trading, having closed Thursday at $7.17 apiece. The company is funding a massive Phase 3 trial for a two-pronged anticoagulant to be used in coronary procedures.
