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: [[ticker: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: [[ticker: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: [[ticker: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.
