The word of the week was “moonshot,” as U.S. Vice President Joe Biden’s cancer initiative convened a summit in Washington, DC. At the gathering, Biden took verbal shots at scofflaw cancer researchers and at drug prices, while the FDA said it would take a shot at restructuring the way it evaluates oncology products.
Gilead Sciences has been a target of drug-price criticism for its hepatitis C treatments, but it dialed back the price of its new one. It also got a pat on the back from Bill Gates. There was plenty more biomedical news this week, from a downsized IPO to downsizing companies, while ugly sexual harassment details emerged in Seattle.
If you want fireworks this weekend, you can either celebrate the 4th of July or watch the latest post-Brexit political developments in Britain. If you want a roundup of the week’s biotech’s news, read on.
—Vice President Joe Biden hosted a summit Wednesday in Washington, DC, for his cancer “moonshot” initiative, with more than 200 satellite events also held around the country. To boost the initiative, which aims to speed the pace of cancer research, FDA said it would consolidate its cancer review divisions under the Oncology Center of Excellence. But as Xconomy reported, details about the reorganization were scant, leaving open questions about whether drug regulation actually needs to move faster.
—In other news from the moonshot day, Biden warned researchers in academia and industry that they would risk losing federal funding if they didn’t follow the law and report their clinical trial results to the public ClinicalTrials.gov database… IBM said it would deploy its Watson systems to help the U.S. Department of Veterans Affairs diagnose its cancer patients, who account for 3.5 percent of the nation’s cancer cases… And two Texas IT companies are building a database with the Medicare records of 1 million cancer patients and will open it to public analysis.
—Gilead Sciences (NASDAQ: GILD) of Foster City, CA, won FDA approval for a hepatitis C treatment called Epclusa that treats all genetic subtypes of the virus and is also the first pill for people with genotypes 2 and 3 of the disease. It combines into one pill the agent sofosbuvir, the active ingredient of Gilead’s blockbuster Sovaldi, and velpatasvir. As drug pricing remains a national issue, Gilead set a price at $72,000 for a 12-week course, cheaper than Sovaldi and Harvoni, which includes sofosbuvir and a second medicine.
—Boston’s PureTech Health, which conceives and launches life science companies, unveiled Sonde Health, which is developing software that listens for warning signs of depression in people’s speech patterns. The technology was funded by the Department of Defense and comes from MIT’s Lincoln Lab. PureTech also bucked the Brexit fallout this week. Traded on the London Stock Exchange, its shares held steady while the market went haywire, then climbed all week through Thursday’s close.
—Buzzfeed ran a lengthy report Wednesday on the sexual harassment charges against University of Washington vaccine researcher Michael Katze. Two university investigations have concluded that he sexually harassed two colleagues and, in the process, misused public funds. Buzzfeed reports that Katze is still drawing his UW salary, but his lab has been shut down.
—In the pink slip department, Cambridge-based Infinity Pharmaceuticals (NASDAQ: INFI) announced 100 layoffs, more than half its workforce, after it terminated its partnership with AbbVie (NYSE: NYSE) around the cancer drug duvelisib. Despite disappointing duvelisib data a few weeks ago, Infinity still aims to press on with more trials… San Diego’s Arena Pharmaceuticals (NASDAQ: ARNA) said late Thursday it would cut 100 employees, nearly three-quarters of its staff. Shares were down nearly 8 percent in aftermarket trading… Boehringer Ingelheim said it would lay off 724 jobs, mainly in sales, across the U.S., Fierce Pharma reported… And Xconomy reported that Waltham, MA-based Forum Pharmaceuticals, which spent more than a decade pursuing a drug for Alzheimer’s and other neurological disorders, is shutting down. The news comes after Forum’s lead drug, encenicline, failed two trials in schizophrenia, and CEO Deborah Dunsire left last month.
—Shares of Cambridge, MA-based Syros Pharmaceuticals (NASDAQ: SYRS), with two drugs in early clinical trials to treat leukemia, began trading Thursday and closed up 45 percent after a $50 million initial public offering.
—Shares of Tesaro (NASDAQ: TSRO) more than doubled Wednesday, from $37.21 to $86.95 apiece, after the company produced positive Phase 3 data in ovarian cancer for a drug called niraparib. Niraparib is a PARP inhibitor, a drug class that has rebounded after some setbacks. AstraZeneca’s olaparib (Lynparza) became the first approved PARP drug in 2014, and several others are being developed, including talazoparib from San Francisco’s Medivation (NASDAQ: MDVN). Analysts wondered if the Tesaro news would push Medivation’s acquisition price higher. It is the target of a hostile bid from Sanofi.
—Last month, Biogen (NASDAQ: BIIB) struck a deal with the University of Pennsylvania on a new wave of gene therapy delivery tools. This week, UPenn revealed more details. A new group of engineered adeno-associated viruses, or AAVs, are being developed as part of a program called AAV 3.0.
—Biotech’s biggest Wall Street losers this week: A Phase 3 trial of San Ramon, CA-based Galena Biopharma’s (NASDAQ: GALE) cancer vaccine nelipepimut-S (NeuVax) was stopped early because it clearly wasn’t helping patients. Galena shares plummeted 83 percent… Shares of San Diego-based Regulus Therapeutics (NASDAQ: RGLS) plummeted almost 50 percent after the FDA placed a clinical hold on its experimental hepatitis C treatment RG-101… Shares of Ann Arbor, MI-based Esperion Therapeutics fell nearly 35 percent after the company reported that the FDA “did not provide clarity on a regulatory pathway” for its cholesterol-lowering drug ETC-1002. To win approval, Esperion might first have to run what’s known as an “outcomes trial,” a massive, expensive study designed to show whether its drug reduces the risk of strokes and heart attacks, not just cholesterol levels.
—Morphic Therapeutics, a new startup from the labs of Harvard University immunologist Tim Springer, debuted with a $51.5 million Series A round led by the venture arms of three pharmaceutical companies. Xconomy spoke with Springer about the effort, in which Morphic will try to develop pills that block the activity of integrins, an alluring yet tricky biological target.
—More deals: Cambridge, MA-based Moderna Therapeutics added to its war chest with a $200 million payment from Merck to develop “personalized” cancer vaccines that pair with Merck’s immunotherapy drug pembrolizumab (Keytruda)… Novartis will pay Xencor (NASDAQ: XNCR) of Monrovia, CA, $150 million upfront in a deal that includes shared rights to two Xencor blood-cancer drugs due to start clinical trials this year… Framingham, MA-based HeartWare International (NASDAQ: HTWR) is being acquired by Medtronic (NYSE:MDT]]) for $1.1 billion in cash. Incidentally, the deal comes seven years after Thoratec—now owned by St. Jude Medical—unsuccessfully tried to buy Heartware for $282 million.
—Durham, NC-based Icagen acquired Sanofi’s research site in Oro Valley, AZ, to help with its drug discovery work.