New startups. New data. Financings. Acquisitions. Legal tussles. FDA advisory panels. It’s been that kind of week in East Coast biotech. So grab some coffee and let’s roll through this week’s headlines.
—This week a new type of cholesterol-lowering drug was in the spotlight, a class of injectable therapies that block the protein known as PCSK9. While FDA advisory panels recommended approval of both New York-based Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi’s ailrocumab (Praluent), and Amgen’s (NASDAQ: AMGN) evolocumab (Repatha), there were some caveats, as Alex Lash reported here.
—After operating stealthily for around four years, Cambridge, MA-based Xtuit Pharmaceuticals emerged with a $22 million Series A round from New Enterprise Associates, Polaris Partners, and several others. The company is zeroing in on the “stroma”—a bunch of different cell types that helps form the structure of organs—and aims to normalize them when they go haywire in cancer and inflammatory liver diseases. I spoke with Polaris partner and CEO Alan Crane about the concept.
—Stony Brook, NY-based Codagenix became the first startup backed by Accelerate Long Island to move on to a Series A investment, grabbing a $2 million round from Long Island VC firm Topspin Partners. Codagenix is using computer algorithms to develop synthetic viruses used to quickly make vaccines; chief operating officer J. Robert Coleman tells Xconomy that the company should kick off its first trial next year.
—Cambridge-based Agios Pharmaceuticals (NASDAQ: AGIO) presented the latest data on its closely watched experimental blood cancer drugs, AG-221 and AG-120, which work by enabling bone marrow cells that would otherwise become cancerous to mature normally. The latest update shows responses from patients with a deadly, aggressive form of blood cancer—acute myeloid leukemia—lasting upwards of 15 months; you can read more about the results at TheStreet.com. Agios also reported data from an early study in healthy volunteers of a third drug, AG-348, for pyruvate kinase deficiency—it’s seen enough positive signs that it’s start testing that drug in a Phase 2 study of PKU patients. Here’s more on Agios and its clinical and regulatory strategy for these drugs.
—Cambridge-based antibiotics startup Spero Therapeutics got a $30 million Series A from Lundbeckfond Ventures, The Kraft Group, Merck Research Ventures, and others to fund its plan to take on drug-resistant bacteria. The strategy for doing so has shifted a bit as Spero has evolved. As CEO Ankit Mahadevia told me, Spero now aims to advance a number of different approaches for treating so-called gram negative infections. One of them Spero recently in-licensed from a small company in Finland.
—Cambridge-based cellular immunotherapy player Unum Therapeutics inked its first partnership, with Seattle Genetics (NASDAQ: SGEN), and then quickly closed a $65 million Series B round that included a group of “crossover” investors, a sure sign that a company is eyeing an initial public offering. CEO Chuck Wilson told me earlier this week that an IPO is indeed “on the horizon” for Unum, which emerged from stealth just eight months ago.
—Clarus Ventures, a VC firm with offices in Cambridge and the Bay Area, closed a new $500 million fund this week. Managing director Scott Requadt says the new fund will be split 50-50 between traditional venture investments and so-called “R&D risk sharing partnerships,” where a Clarus company helps develop advanced drug candidates (or already approved ones for different diseases). It’s also scaling back investments in diagnostics and medical devices.
—Cambridge-based Bluebird Bio (NASDAQ: BLUE) said this week that the National Institute of Health Recombinant DNA Advisory Committee has advised the company to wait one to two years—while accumulating more data on its gene therapies—before starting a trial in the U.S. on children with beta-thalassemia. Bluebird isn’t bound to the committee’s recommendation, however. You can read more at TheStreet.com, and check out this piece for a detailed look at Bluebird’s clinical plans.
—Summit, NJ-based Celgene (NASDAQ: CELG) paid Michigan’s Lycera $82.5 million up front an option to license a group of drugs for cancer and immune-mediated diseases (such as inflammatory bowel disease) and potentially buy the company outright later on. Sarah Schmid spoke with Lycera founder and outgoing chief scientific officer Gary Glick about the deal, and the journey he’s been through at Lycera.
—Cambridge-based Sage Therapeutics (NASDAQ: SAGE) said that SAGE-547, a drug it’s developing for rare epilepsies and other disorders, may have helped reduce post-partum depression in four patients in an early, open-label, exploratory study. Sage now aims to test that theory in a placebo-controlled trial with a different formulation of the drug. Shares surged more than 15 percent after the disclosure; Forbes has more here.
—Two local RNA interference drug developers, Alnylam Pharmaceuticals (NASDAQ: ALNY) and Dicerna Pharmaceuticals (NASDAQ: DRNA) took to court this week after Alnylam sued Dicerna for allegedly misappropriating trade secrets. Specifically, Alnylam claimed that ex-Merck scientists hired by Dicerna brought confidential information with them about a subcutaneous method of delivering RNAi drugs, enabling Dicerna to develop a technology it wouldn’t have otherwise. Those scientists worked at Sirna Therapeutics, the RNAi group Merck bought several years ago and later sold to Alnylam (Alnylam claims, in documents, to have beat out Dicerna in the bidding for Sirna). Dicerna denied those claims, and claimed that Alnylam sued it “based on assumptions rather than facts.” For more check out The RNAi Therapeutics Blog.
—Two local biotechs tapped Wall Street for cash this week: Ironwood Pharmaceuticals (NASDAQ: IRWD) sold $300 million in convertible notes, and Amicus Therapeutics (NASDAQ: FOLD) raised $225 million in a stock offering.
Photo of Boston courtesy of TMAB2003 via Creative Commons.