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Bio Roundup: ASCO Digested, Juliet Unveiled, PTC Slated & More

Xconomy National — 

The New York Times Magazine wrote a few weeks ago about the extraordinary metabolic changes in a python after it gulps down a 50,000 calorie meal.

The biomedical world was like a postprandial python this week; after extending its maw around the supersized meal of news and data from the American Society for Clinical Oncology meeting over the weekend, life science info flow nearly came to a halt. (James Comey might have had a wee bit to do with that, as well.)

But not entirely: For example, after months of people asking where the heck art thou, Novartis dropped partial data from its JULIET study, a trial testing one of its CAR-T cellular immunotherapy programs in lymphoma patients.

We’ll round up ASCO, Juliet, and a few other sonnets of info for you. Just don’t expect it in iambic pentameter. The roundup’s the thing.

ASCO WRAPS

—Our own review put the top-line ASCO news into a few buckets, including studies of cancer care’s financial burden, updates on immunotherapy programs, and genomic sequencing and diagnostics.

—The Timmerman Report took a different tack, listing the companies making news or presentations in alphabetical order. (Subscription required.) And the Washington Post took a spin around the exhibit hall floor to note, if not taste, the edibles that pharma companies were giving away.

—One ASCO story Xconomy highlighted over the weekend was the biggest Wall Street winner, Loxo Oncology (NASDAQ: LOXO), which saw its share price jump more than 40 percent. Loxo disclosed data that patients with a variety of different cancers that shared one commonality—a genetic alteration called a TRK fusion— responded to its drug larotrectinib. Cancer experts interviewed by Xconomy believe that the data could spur broader adoption of cancer genetic tests.

—ASCO featured an update on the frenzy of cancer immunotherapy combinations being tested, and some of the more closely watched pairings feature so-called IDO inhibitors, with a drug from Incyte (NASDAQ: INCY) leading the way. But not all IDO inhibitor developers are thriving: Genentech returned rights to the IDO blocker GDC-0919 to Newlink Genetics (NASDAQ: NLNK) two days after ASCO wrapped up, sending Newlink’s shares down more than 40 percent.

IN OUR NATION’S CAPITAL

—The White House announced that National Institutes of Health director Francis Collins is staying put. In charge since 2009, Collins will continue to lead the sprawling agency as the Trump administration tries to cut its budget by 18 percent next year.

—The GOP healthcare bill to replace Obamacare was under discussion among Republican senators this week. The tea leaves gauging their enthusiasm were swirling quite a bit.

—New FDA commissioner Scott Gottlieb has been vocal about using the agency’s powers to battle the opioid epidemic, and the agency made a splash on that front this week. The FDA asked Endo Pharmaceuticals (NASDAQ: ENDP) to pull its opioid drug, oxymorphone hydrocholoride (Opana ER), from the market due to “public health consequences of abuse,” the first time the agency has made such a request. Here’s more in Forbes.

—In other FDA news, the agency has set a Sept. 28 meeting for outside experts to consider approval of the Duchenne muscular dystrophy drug ataluren (Translarna). The FDA has twice declined to consider ataluren, but its developer PTC Therapeutics (NASDAQ: PTCT) has gotten a review by filing an application “over protest.”

—Novartis also has a date with FDA advisors—July 12, to be exact. The advisors will recommend whether the agency should approve the CAR-T cell therapy CTL019 as a treatment for non-Hodgkin lymphoma. Novartis released a first look at the data under consideration; rates of remission were solid in the 51 patients evaluated (out of 141 enrolled), and there were no deaths or cases of cerebral edema. A top Novartis official told Bloomberg that the firm is considering “multiple creative options” for pricing.

IPOs AND OTHER DEALS

—Cambridge, MA-based Aileron Therapeutics, a developer of “stapled” peptide drugs going after one of cancer’s notoriously hard targets, p53, filed papers outlining its IPO attempt.

Dova Pharmaceuticals wants to go public to support its work on a drug to treat low platelet counts that the Durham, NC, biotech acquired from Eisai.

—Looking to build up its diabetes drug pipeline, Eli Lilly (NYSE: LLY) will pay KeyBioscience $55 million up front for the Denmark-based biotech’s diabetes drug candidates.

—Platelet Biogenesis raised $10 million in a Series A round that the Boston biotech plans will apply toward preclinical tests on its process for making platelets from stem cells.

—Austin, TX, biotech Lung Therapeutics raised $14 million for Phase 1 clinical trials testing its lead drug, a treatment for the sometimes deadly complications of pneumonia.

—A Teva Pharmaceutical (NYSE: TEVA) drug developed to prevent migraine headaches met its goals in a Phase 3 clinical trial treating episodic migraines. Those results came a week after the company reported positive results for the same drug in a separate Phase 3 trial in chronic migraines.

STAFF CUTS AND STEP-DOWNS

—Skin drugs developer Novan (NASDAQ: NOVN) is laying off 20 percent of staff and shaking up its executives as the Durham, NC, biotech retrenches following the Phase 3 clinical trial failure of its acne drug in January.

—-Meanwhile, Endocyte (NASDAQ: ECYT), a West Lafayette, IN-based cancer drug developer, announced it would slash headcount 40 percent following the failure of a non-small cell cancer drug in a Phase 1 clinical trial.

Christoph Westphal stepped down as the CEO of Flex Pharma (NASDAQ: FLKS), though he’ll remain chairman of the company. Westphal similarly vacated the CEO seat of Verastem (NASDAQ: VSM), another company he co-founded, after it went public.

—Young entrepreneurs, investors, academics, and others shared their perspective on the present and future of New York biotech at an Xconomy event last week. Check out a few of our takeaways and photos here.

Ben Fidler and Frank Vinluan contributed to this report.

Photo by Ano Lobb under a Creative Commons 2.0 license.