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Bio Roundup: IDO Fallout, Express Scripts Dumps Amgen, Isaly Out & More

Xconomy National — 

Here’s a case study of how fast things can change in biopharma. For a few years, a type of cancer drug called an IDO inhibitor was all the rage, a promising path to expanding the reach of immunotherapy. Major drug makers were dealing, too. Through acquisitions and alliances, they rolled out a spate of large-scale combination trials.

Now, in the wake of one failed trial, the IDO train has skidded off the tracks. This week, Bristol-Myers Squibb, Merck, and AstraZeneca all curtailed plans to run additional studies with IDO blockers, adding to a recent, similar decision from Newlink Genetics. Bristol’s reason: “emerging data on the IDO pathway.” The episode is worth keeping in mind when the American Society of Clinical Oncology’s meeting gets underway next month, and some of the next new, hot cancer combos are trotted out.

Elsewhere the nation’s top drug buyer cut an unusual deal, a biohacker died, and a controversial biotech venture capitalist stepped down. We’ll round it all up below.

THIS WEEK IN CANCER IMMUNOTHERAPY

—Bristol-Myers Squibb (NYSE: BMY) became the latest company to curtail clinical testing of a cancer drug that targets the IDO enzyme. The move follows the Phase 3 failure last month of an Incyte (NASDAQ: INCY) drug that works in a similar way.

—Johnson & Johnson paid $140 million up front to buy privately held BeneVir, a developer of oncolytic virus cancer therapies, one of the tools drugmakers are using in combination immunotherapy regimens.

—Merck said a combination of its immunotherapy pembrolizumab (Keytruda) and chemotherapy recently hit a pre-specified secondary goal—overall response rate—upon an interim look at a Phase 3 study in squamous metastatic non-small cell lung cancer patients. Merck, which will present the data at ASCO next month, believes the data are enough for FDA approval. Pembro-chemo is already approved for non-squamous NSCLC patients.

—Merck also expanded its existing alliance with Moderna Therapeutics to develop messenger RNA cancer vaccines, adding a new product, experimental mRNA-5671, that will advance into combination trials with other immunotherapies. Merck made a new $125 million investment in Moderna in the deal.

WHEELING & DEALING

—Regeneron Pharmaceuticals (NASDAQ: REGN) and partner Sanofi cut an unusual deal with Express Scripts (NYSE: ESRX), the nation’s largest drug-buying middleman, to lower the price of their $14,000-a-year cholesterol-lowering therapy alirocumab (Praluent) in return for Express Scripts quickly approving treatment requests. As part of the deal, Express Scripts kicked Amgen’s (NASDAQ: AMGN) rival heart drug evolocumab (Repatha) off of its formulary, which covers about 25 million Americans.

—Ironwood Pharamceuticals (NASDAQ: IRWD) announced plans to split itself in two and hive off a new yet-to-be-named business developing drugs for rare diseases. Separately, the company railed against plans by activist investor Sarissa Capital Management to nominate its chief investment officer, Alex Denner, to the company’s board.

—Spark Therapeutics (NASDAQ: ONCE) sold its priority review voucher, which speeds up an FDA review for an experimental drug, to Jazz Pharmaceuticals for $110 million. Spark got the voucher when the FDA approved its gene therapy voretigene neparvovec (Luxturna).

—Sarepta Therapeutics (NASDAQ: SRPT) inked a pact with Myonexus Therapeutics, a Nationwide Children’s Hospital spinout developing gene therapies for rare muscular dystrophies. Sarepta paid $60 million up front to co-develop five gene therapy products, and nabbed an option to buy the startup outright.

—SteadyMed (NASDAQ: STDY), a developer of drug-device combination treatments, reached a deal to be acquired by United Therapeutics (NASDAQ: UTHR) for $141 million up front.

—Harvard University’s Wyss Institute and CAR-T therapy developer Cellectis (NASDAQ: CLLS) are teaming up to engineer human cell lines that are resistant to infection from viruses and prions.

—Vivus (NASDAQ: VVUS), which has struggled to sell its weight loss drug phentermine/topiramate (Qsymia), expanded its scope by acquiring pancrelipase (Pancreaze), a digestive drug marketed by Janssen Pharmaceuticals. Vivus also secured up to $120 million in debt financing from Athyrium Capital Management.

REGULATORY UPS & DOWNS

—In a speech on Thursday, FDA commissioner Scott Gottlieb blamed high drug prices partly on the “system of rebates between payers and manufacturers.” Gottlieb intimated the federal government may “re-examine” that system. Here’s more in Axios.

—The Committee for Medicinal Products for Human Use voted against approving Sarepta’s Duchenne muscular dystrophy drug eteplirsen (Exondys 51), delaying its path forward in Europe. Sarepta said it plans to re-apply, hoping for a different result.

—An FDA advisory panel split on its support of Achaogen’s (NASDAQ: AKAO) antibiotic plazomicin, unanimously agreeing on the drug’s safety and efficacy for complicated urinary tract infections but voting against the compound as a treatment for infections in the blood.

—A CAR-T therapy from Novartis (NYSE: NVS) became the first to gain approval in a second indication. As expected, the FDA green-lighted tisagenlecleucel (Kymira) for non-Hodgkin lymphoma, setting up direct competition with axi-cel (Yescarta) from Kite Pharma, now part of Gilead Sciences (NASDAQ: GILD). Kymriah was first approved for pediatric leukemia, a much smaller patient group.

—The FDA rejected, however, Novartis’s biosimilar version of the Roche cancer drug rituximab (Rituxan), a month after shooting down another biosimilar rituximab from Celltrion.

ON THE IPO TRAIL

—Scholar Rock filed for an IPO to bring its lead drug, an experimental spinal muscular atrophy treatment called SRK-105, into human trials.

—Anti-aging biotech Unity Biotechnology went public, raising $85 million to test treatments for osteoarthritis and eye diseases.

—Alzheon formally withdrew its IPO plans, leaving the Framingham, MA, company needing to find another way to finance Phase 3 tests of its experimental Alzheimer’s disease drug ALZ-801.

—Gilead is paying Bay Area neighbor Verily up to $90 million over three years, according to Forbes, to analyze immune cells and help discover new medicines for autoimmune diseases.

MYSTERIES & CONTROVERSIES

—Aaron Traywick, who injected himself live on the Internet with an untested herpes virus, died in a flotation tank at a Washington, DC, spa. He was 28. His live spectacle spurred a backlash from biohackers like Josiah Zayner, as Xconomy reported here. Traywick filed a defamation suit against Zayner and news outlet Gizmodo for “defamatory statements.” Traywick’s cause of death has not been confirmed.

—Biotech hedge fund chief Sam Isaly resigned from his firm OrbiMed Advisors four months after … Next Page »

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