[Updated with Novo Nordisk obesity news, 9/26/14, 12:38pm. See below.] Out west this week, there was Ebola-related pharmaceutical news large and small. Vancouver biotech Tekmira Pharmaceuticals (NASDAQ: TKMR) got emergency clearance from the U.S. and Canada to administer its unproven Ebola drug to people with the infection, and the company announced a few people had already received it.
On the small side, a tiny San Francisco startup asked strangers to donate a few thousand dollars to fund its cancer drug in lab tests against Ebola. And the strangers did, in one of more unusual crowdfunding stories of the year.
The other theme this week was immunotherapy. The biggest news in the hot area didn’t take place on the West Coast (that would be the $104 million Series A round for British biotech Amplimmune). But as you’ll see below, local developers Eureka Therapeutics raised $21 million from a syndicate of investors based in Asia, and Amgen spinout Atara Biotherapeutics put a marker down on the technology, taking an option to license immunotherapy programs from New York’s Memorial Sloan Kettering Cancer Center. We’ve got a lot of items this week, so let’s get to the roundup.
—Tekmira Pharmaceuticals of Vancouver, BC, had two Ebola-related news items this week. It said Monday it has the green light from the FDA and Health Canada to provide its experimental Ebola treatment TKM-Ebola on an emergency basis to people with confirmed or suspected infections. The FDA gave its OK as a “compassionate use exemption,” which means those using it are not part of a controlled clinical trial. Tekmira said “a number of people” had already been administered the drug under the exemption, including an American doctor who was infected in Liberia and treated in Nebraska.
On Tuesday, Tekmira said it would produce a drug to test against the current strain of Ebola wreaking havoc in several West African countries. (TKM-Ebola was developed to combat a different strain.) The new treatment will be part of a trial in those countries, led by a consortium of health groups including Medicins Sans Frontieres, the World Health Organization, and the U.S. Centers for Disease Control. The U.K.’s Wellcome Trust is providing about $4 million to fund the drug’s manufacture and the trials on the ground.
—Tiny San Francisco startup OncoSynergy raised $5,000 through crowdfunding site Experiment to do preclinical, cell-based tests of its cancer drug against Ebola. The firm, a spinout from the University of California, San Francisco, received orphan drug designation from the FDA in August for its cancer drug, which has not yet reached human trials. The drug targets CD-29, a protein that helps cells adhere to other surfaces. It’s also believed to be the entry port Ebola uses to infect cells and replicate, so OncoSynergy will see if its antibody treatment can block the virus.
—Danish drugmaker Novo Nordisk made official what was speculation last week: It will open an obesity research center in Seattle, growing to about 60 people once fully operational in 2016. Kevin Grove, a senior scientist at Oregon Health & Science University in Portland, will be the unit’s chief. The obesity team will be located with Novo’s Type 1 diabetes research group, which was established in 2009.
—A collaboration struck last year between San Diego’s Avalon Ventures and GlaxoSmithKline (NYSE: GSK) has resulted in the formation of two more biotech startups in San Diego. Silarus Therapeutics is developing drugs for disorders that involve iron regulation in red blood cell production. Thyritope Biosciences is working on drugs for Graves’ disease. Both will receive up to $10 million in Series A funding from the Avalon-GSK partnership. The VC-pharma collaboration is one of a handful of new models to launch biotechs cheaply—sometimes virtually—and move their main assets quickly to a proof-of-concept stage. Through its San Diego drug discovery group Inception Sciences, Versant Ventures operates a similar model that has started at least five of what it calls “build to buy” startups in partnership with pharma companies.
—San Diego-based Lpath (NASDAQ: LPTN) said it is raising $12.5 million through a direct offering of shares and warrants placed by Maxim Group. Lpath develops therapeutic antibodies to target bioactive signaling lipids that play a role in cancer and other diseases. Lpath plans to use net proceeds for R&D and general corporate purposes, including capital expenditures.
—Gilead Sciences (NASDAQ: GILD) of Foster City, CA, will apply to U.S. and European regulators for marketing approval of its four-drug HIV combination, known in shorthand as E/C/F/TAF, by the end of this year, based on positive Phase 3 data it unveiled Wednesday from two studies. Gilead already has a four-drug combo, Stribild, on the market, but the new product, also taken once daily, offers a lower dosage of one component, tenofovir. The TAF combination didn’t knock out the virus any better than Stribild in the two head-to-head studies, but it offered better kidney and bone safety data.
—Blaze Biosciences of Seattle said Thursday its lead product, BLZ-100, has received regulatory clearance to begin a Phase 1b trial of up to 21 patients with glioma, a type of operable brain tumor. Injected intravenously, BLZ-100 enters glioma tumor cells and marks them with a dye so that surgeons can highlight the cells with a fluorescent camera and remove them without harming normal tissue. The company would like to extend its technology, which it calls Tumor Paint, to other cancers treatable with surgery. It has raised about $19 million since it launched in 2010.
—Atara Biotherapeutics of Brisbane, CA said Tuesday it has taken an option to license cancer and antiviral immunotherapies from Memorial Sloan Kettering Cancer Center in New York. Atara has paid an undisclosed amount of cash and stock for the exclusive option on three T-cell therapies already in the clinic. Exercising the option will trigger upfront payments and potential milestones and royalties. Atara was slated to go public in July, getting close enough to set a sales target of 5 million shares between $14 and $16 apiece, but it postponed the offering without explanation. (A Thomson Reuters affiliate, citing anonymous sources, reported the firm had to postpone because of fresh preclinical data about its ovarian cancer treatment, but that report could not be confirmed.)
—The cancer immunotherapy news this week extends to funding, too. The U.K.’s Adaptimmune pulled in $104 million, and a day later, Emeryville, CA-based Eureka Therapeutics announced a $21 million Series C round led by Beijing-based Yuan Capital and previous investors Majuven, Acorn Campus Ventures, Suma Ventures, and Harbinger Venture Capital, all of which have a presence in East Asia. Eureka is developing antibodies against cancer, which is an “off the shelf” approach that is behind the first approved cancer immunotherapy, Bristol-Myers Squibb’s Yervoy. It is different from the T-cell engineering approach personalized to each patient being pursued by Juno Therapeutics, Novartis (through its University of Pennsylvania collaboration), and Adaptimmune.
—Rare disease specialist BioMarin Pharmaceutical (NASDAQ: BMRN) said Thursday that an unnamed generic drug maker has told the FDA it wants to make a generic version of BioMarin’s sapropterin dihydrochloride (Kuvan), a treatment for phenylketonuria, a genetic disorder. The San Rafael, CA-based company said it would file a lawsuit against the company and defend its patents. Kuvan was approved by the FDA in 2007 and its orphan drug exclusivity expires at the end of 2014. It netted $167 million in sales last year.
—San Diego’s Allele Biotechnology & Pharmaceuticals raised $7 million in its first round of institutional funding, 15 years after CEO Jiwu Wang founded the company. The Chinese private equity firm Yuan Capital led the round and was joined by Yifang Ventures, an early stage venture firm led by Eric Xu, the co-founder of Chinese-language search engine Baidu. Allele plans to use the capital to expand its production of Allele’s proprietary stem cells for potential cell therapy programs, cell-based assays, and customer stem cell banking.
—San Diego-based Meritage Pharma said a mid-stage trial of its version of the drug budesonide reduced the inflammation and dysfunction in adolescents and adults with esophageal eosinophilia (EoE), a chronic disease that makes it difficult to swallow. Meritage has developed a proprietary oral formulation of budesonide that is designed to coat the esophagus. Budesonide is a corticosteroid with an established safety profile in several FDA-approved products for treating pediatric asthma, allergic rhinitis, and Crohn’s disease. Meritage said EoE may be triggered by certain foods and environmental allergens, and the number of U.S. cases is expected to grow from 180,000 today to 272,000 by 2018.
—Xconomy San Diego editor Bruce Bigelow contributed to this post.