Bio Roundup: Ex-Kiters Say Allo, NASH Cash & Data, Alkermes No & More

Xconomy National — 

Happy Friday, everyone. We’ll start this week with biotech deals, one featuring a couple of CAR-T heavyweights who have re-emerged after selling Kite Pharma for $12 billion. They will try to shepherd to market a different type of the promising cancer immunotherapy: allogeneic T cells that come from donors, not from a patient’s own blood.

After the deals, we’ll move on to data. The FDA didn’t smile upon a big submission of depression studies from Alkermes, while those fighting liver disease got a mixed slate of data as a big medical conference looms. There were plenty of policy and drug-price headlines, as well. Let’s mosey on over to the roundup.


—Former Kite Pharma executives are back, this time heading up a new biotech, Allogene Therapeutics, which has $300 million to develop off-the-shelf CAR-T therapies for cancer. This approach is meant to be cheaper and easier than the CAR-T therapy that Kite helped bring to market. Allogene is taking over the U.S. development of a CAR-T therapy that Pfizer licensed in 2015.

—Universal, or allogeneic, cell therapies made headlines again, with Eli Lilly (NYSE: LLY) licensing cell encapsulation technology from Sigilon Therapeutics, the Flagship Pioneering-backed startup founded by MIT’s Bob Langer and others. As part of the $63 million deal, Sigilon will develop a universal cell therapy for type 1 diabetes and will encapsulate the insulin-producing cells before transplantation to protect them from the immune system.

—While several companies compete in the U.S. to make drugs for the fatty liver disease known as nonalcoholic steatohepatitis, or NASH, Terns Pharma is focused on China. Terns said it bought three experimental drugs from Eli Lilly and hopes to start clinical trials in China next year.

—Boston Scientific (NYSE: BSX) paid $40 million up front to acquire the stake of Securus Medical Group it did not already own. The deal brings to Boston Scientific Securus’s FDA-cleared technology for taking and visualizing heart temperatures during cardiac ablation, which the medical device giant will add to its lineup of products for the procedure.

—Not all BioCryst Pharmaceuticals (NASDAQ: BCRX) shareholders agree with its proposed merger with Idera Pharmaceuticals (NASDAQ: IDRA). In a letter to the Durham, NC, company’s board, RA Capital said a merger won’t improve the prospects of BioCryst’s lead drug BCX7353, a pill meant to reduce the swelling attacks experienced by patients who have hereditary angioedema.

—Roche agreed to buy a multiple sclerosis program aimed at regenerating myelin, the protective sheath around nerves. The program came from Versant Ventures, which launched it in 2014. Roche held an option to acquire as the program neared clinical studies. Terms were not disclosed.

—For an undisclosed sum, Ferring Pharmaceuticals of Switzerland agreed to buy microbiome developer Rebiotix of Roseville, MN, and its Phase 3 treatment for C. difficile infection.


—The FDA refused to review an Alkermes (NASDAQ:ALKS) drug for people with major depressive disorder who don’t respond to the standard-of-care drugs known as SSRIs. The agency asked for another clinical trial, sending Alkermes shares down 26 percent by end of Thursday.

—A Conatus Pharmaceuticals (NASDAQ: CNAT) drug, emricasan, failed a Phase 2b study in liver transplant patients. The San Diego biotech said the results do not affect three mid-stage NASH studies it is conducting with partner Novartis (NYSE: NVS).

—Also in San Diego, Medicinova (NASDAQ: MNOV) had better liver news. It ended a phase 2 study of its drug tipelukast early because of strong effectiveness in patients with NASH and NAFLD, a precursor to NASH.

—A Nature paper that raised alarms last year about the gene-modification technology CRISPR-Cas9, kneecapping stocks of CRISPR-related companies, was officially retracted last weekend. The paper sparked immediate criticism, and Nature issued “an expression of concern” a few months later. Retraction Watch has a detailed report.


—Money-back guarantees won’t necessarily make a drug cost-effective if its price is too high to begin with, according to an article in the Annals of Internal Medicine. The authors, which include Dan Ollendorf from the drug-price watchdog the Institute for Clinical and Economic Review (ICER), analyzed data on evolocumab (Repatha), a pricey cholesterol medicine from Amgen (NASDAQ: AMGN).

—Britain’s drug-price watchdog was also on the prowl. It advised the country’s National Health Service that eczema drug Duxipent from Regeneron Pharmaceuticals was too expensive.

—Robert Redfield, the incoming director of the Centers for Disease Control and Prevention, told CDC staff that the agency’s credibility stems from its “science-based and data-driven” work. Redfield is a University of Maryland professor specializing in AIDS research.

—Federal officials unveiled new opioid-crisis strategies at the National Rx Drug Abuse and Heroin Summit in Atlanta. NIH director Francis Collins announced a doubling of research spending on addiction and opioid misuse under the Helping to End Addiction Long-term (HEAL) initiative. FDA commissioner Scott Gottlieb called on social media companies and Internet providers to crack down on ads for illegal opioids.

—The Centers for Medicare and Medicaid Services said enrollment in Affordable Care Act (aka Obamacare) exchanges was down 3.3 percent. Politico dug into the numbers and the reactions.


—Macrolide Pharmaceuticals of Watertown, MA, raised $20 million in funding to push into human testing for its lead antibiotic… San Francisco-based Eidos Therapeutics now has $64 million to start a Phase 2 study of its treatment for transthyretin amyloidosis (ATTR)… Virta Health, also of San Francisco, raised $45 million to back its software approach to treating diabetes… Arvinas of New Haven, CT, has corralled $55 million to move closer to clinical studies for its cancer drugs.

Corie Lok and Frank Vinluan contributed to this report.