Alex Lash
We’ve grouped our items according to topic this week. First come the financings, led by the relocated Laguna Pharma in San Diego. Then comes the clinical and regulatory news, which is topped by the long-awaited results of a government-sponsored trial to compare three different treatments—including two from Genentech—for diabetic macular edema, a type of vision loss due to diabetes. We finish up with assorted deals and announcements. Let’s get to the roundup.
—Laguna Pharmaceuticals, a biotech developing a new drug for heart arrhythmias, has moved to San Diego from Ohio, raised $30 million in venture funding, and hired former Amira Pharmaceuticals CEO Bob Baltera to run the company. Laguna was founded in 2006 as ChanRx, and has raised a total of at least $35 million.
—Unchained Labs of Pleasanton, CA, said last Friday it has raised a $25 million Series A round from Novo Ventures, Canaan Partners, and TPG Biotech. It also bought its first product, a device to measure protein stability for use in biologic drug development.
—Another Bay Area device company, Invuity of San Francisco, raised $20 million from Wellington Management and former Life Technologies CEO Greg Lucier, who will join the Invuity board. The firm makes visualization systems for surgery.
—Seattle’s nonprofit IDRI said Thursday it has received a $4 million grant from the U.S. Biomedical Advanced Research and Development Authority to help develop pandemic flu manufacturing expertise in developing countries.
—Two life sciences companies in the San Diego area have postponed their IPOs. AltheaDx, which hoped to raise $60 million when it filed in December, enables doctors to match patients’ genetic profiles with the optimal drugs. In Vista, CA, AutoGenomics cited poor market conditions in postponing its $46.6 million IPO try. It sells a molecular diagnostics system for genetic testing in clinical laboratories.
—Carbylan Therapeutics of Palo Alto, CA, a developer of a pain treatment for knee arthritis, also postponed its attempt to go public. Its most recent goal, from a Jan. 23 regulatory filing, was to raise $93 million.
—Diagnostics maker Invitae (NYSE: NVTA) of San Francisco, fared much better. The company closed its IPO with its underwriters selling more than 950,000 extra shares, bringing Invitae nearly $117 million from the offering in total.
—Roche’s Genentech division saw its products ranibizumab (Lucentis) and bevacizumab (Avastin) lose out to Regeneron Pharmaceuticals’s (NASDAQ: REGN) aflibercept (Eylea) in diabetic macular edema, a type of diabetes-related vision loss that affects 750,000 Americans. The data came from a rare and significant head-to-head study run by the National Institutes of Health. Lucentis and Eylea are approved for DME; Avastin is not but is commonly prescribed off-label in smaller doses.
—Genentech said Wednesday the FDA has granted priority review to the combination of cobimetinib and vemurafenib (Zelboraf) for the treatment of patients with melanoma driven by a genetic mutation known as BRAF V600. The FDA’s decision date is August 11. Neither drug originated at Genentech. Cobimetinib came from South San Francisco, CA-based Exelixis (NASDAQ: [[ticker: EXEL]]), and vemurafenib from Plexxikon of Berkeley, CA. Genentech shares U.S. commercial rights to vemurafenib with Plexxikon’s parent company Daiichi Sankyo.
—Amgen (NASDAQ: [[ticker: AMGN]]), of Thousand Oaks, CA, said late last week that two FDA advisory committees will review in late April its cancer immunotherapy talimogene laherparepvec for treatment of metastatic melanoma.
—Ignyta (NASDAQ: RXDX) said Tuesday the FDA gave its orphan drug designation to the company’s lead candidate, a tyrosine kinase inhibitor branded as entrectinib, for certain types of colorectal cancer.
—Seattle Genetics (NASDAQ: SGEN) of Bothell, WA, said Tuesday it has begun a Phase 1 trial of SEA-CD40, its first antibody to feature boosted stimulus of a patient’s immune system against cancer. The trial will enroll patients with multiple types of advanced solid tumors, according to the company.
—A regenerative cell therapy developed by San Diego-based Cytori Therapeutics (NASDAQ: CYTX) was used last week for the first time to treat a patient with a meniscus tear, a common knee injury. The company said the early stage study is intended to assess the safety and efficacy of injecting adipose-derived stem cells into the surgically repaired meniscus of up to 60 patients. Cytori also is beginning a mid-stage trial of its cell therapy for treating osteoarthritis.
—We reported last Friday on the emergence of Cellular Research, a Palo Alto, CA-based company developing a single-cell analysis platform to compete with the likes of Fluidigm (NASDAQ: FLDM), which announced Thursday it will preview its new Polaris system at an upcoming conference. Cellular Research’s CEO and cofounder is Steve Fodor, one of the pioneers of the microarray.
—Kite Pharma (NASDAQ: KITE) of Santa Monica, CA, said Thursday it has leased manufacturing space in its hometown and in nearby El Segundo, CA, for its cell-based cancer immunotherapy products. Launch of its lead product is expected in 2017.
—Hyperion Therapeutics (NASDAQ: HPTX) said Tuesday it has resolved legal disputes with Israeli firm Clal Biotechnology Industries that were related to a diabetes treatment Hyperion gained in its acquisition of Andromeda Biotech from Clal last year. Hyperion will finish a Phase 3 trial of the drug, at which point Clal can buy it back.
—San Diego-based OncoSec Medica and Durham, NC-based Heat Biologics (NASDAQ: HTBX) each have technologies related to cancer immunotherapy, and they have agreed to evaluate potential combinations of them. No financial terms were disclosed.
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