June 16, 2023

The need-to-know this morning

The FDA approved Columvi, a bispecific antibody made by the Genentech unit of Roche, for the treatment of patients with advanced, large B-cell lymphoma.
The FDA extended by three months the review of momelotinib, a treatment for myelofibrosis made by GSK. The new approval decision date is Sept. 16.
Coherus Biosciences said it will acquire Surface Oncology for $65 million, adding two experimental cancer immunotherapies to its pipeline.

podcast

Can unicorns survive without data?

Did biotech get over its skis? And what is going on at Biogen? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast.

Our colleague Allison DeAngelis joins us to share her reporting on how the handsomely funded Laronde Therapeutics, billed as "Moderna 2.0," ran into behind-the-scenes problems with its scientific data. We also discuss how Biogen's boardroom scandal has roiled a company that was supposed to be entering a new era.

Listen here.

oncology

How treating cancer in dogs can help humans

Although there are many more people than pet dogs in this country, nearly 6 million domestic canines — about triple the number of humans — will get a cancer diagnosis this year. This discrepancy could actually offer a trove of information about how to treat the disease — if dogs begin to regularly get treated for cancer with next-generation therapeutics. There are many genetic similarities between human and dog cancers, making them "about as perfect a model of human cancers as we could hope for," opine Christina Lopes, CEO of One Health, and Stanford biomedical data science professor James Zou.

OneHealth is building a massive dataset that collects genomic data from the tumors of thousands of dogs, with an aim of finding precision treatments for these pets. And they found an "unmistakable pattern" that showed how similar these cancers are to our own: Dogs respond to the same medicines, and have the same prognosis. And, interestingly, the scientists there found that a cohort of canine cancer patients who had received off-label drugs saw a dramatic increase in their median survival rates. This sort of information, when extrapolated to humans, might ultimately save many lives, the authors say.

covid

FDA panel says Covid booster should target XBB subvariant

The new round of Covid shots should target an XBB subvariant of the virus, FDA advisers unanimously recommended yesterday. By targeting an XBB strain, the shot will effectively ward off other forms of Covid that are circulating, scientists from the VRBPAC said. Pfizer and Moderna are developing new mRNA shots this summer to distribute in the fall, the Wall Street Journal writes, as is Novavax with its protein-based shot.

That said, fewer people seem likely to to take the inoculations. Only 17% of adults received the latest booster that targeted Omicron, per the CDC. The new shot will be paid for partly by commercial insurers, as opposed to before, when it was fully government-funded.

lecanemab

Formally mitigating risk for Alzheimer's drugs

The buzzy Alzheimer's drug lecanemab is most likely going to secure approval, and experts are cautiously optimistic — but also worried. Lecanemab, and a similar amyloid-clearing experimental medicine, donanemab, offer hope to people with the neurodegenerative disease, but also have the same risks to the brain: They can cause tiny hemorrhages and swelling.

Jason Karlawish, a medical ethics and neurology expert at University of Pennsylvania, opines that the FDA ought to create a Risk Evaluation and Mitigation Strategy, or REMS, to create a balance between access and safety for these medicines. Regulators have done this for more than 300 drugs since 2007, requiring education and monitoring around a drug to manage or prevent risk.

"I'm optimistic. Some patients will benefit from these drugs. But I'm also a realist. Some patients will be harmed," he writes. "A REMS will mitigate the worry that these harms shouldn't have happened."