Cancer
Competitive punches rough up Arcellx's CAR-T cancer ambitions
From my colleague Adam Feuerstein: The biotech's stock fell 17% yesterday, shedding nearly $900 million in market value. Investors reacted to the release of two research abstracts for the upcoming American Society of Hematology annual meeting that signaled formidable competitive threats to Arcellx's BCMA-targeted CAR-T therapy in multiple myeloma.
First, Johnson & Johnson revealed detailed results from a Phase 3 study of two of its multiple myeloma drugs, Tecvayli combined with Darzalex, that showed an overall survival benefit rivaling what has been reported with CAR-T therapy in similar patients.
Second, Kelonia Therapeutics showcased early but impressive results from a study of its BCMA CAR-T therapy for multiple myeloma that edits immune cells inside the body. A lot of questions remain unanswered about the future of so-called in vivo CAR-T treatments for cancer, but the emerging technology has the potential to leapfrog Arcellx and its ex vivo CAR-T treatment, which needs to be made from harvested patient cells in a lab.
alzheimer's
J&J study fail casts doubt on tau mechanism
J&J has terminated a mid-stage study of its Alzheimer's candidate targeting a protein called tau, after early data suggested the treatment would not prove more effective than placebo.
The decision could dampen enthusiasm for the emerging class of tau-targeting candidates also being developed by Biogen, UCB, and Voyager Therapeutics.
Scientists have long been trying to find new drug mechanisms that can work against Alzheimer's. The approved drugs on the market target a similar protein called amyloid, but have shown only modest benefits on disease progression.
Read more from STAT's Damian Garde and Jason Mast.
glp-1s
Do Novo results mean GLP-1s don't work in Alzheimer's?
We also got news of another study failure yesterday: Novo Nordisk's semaglutide did not slow Alzheimer's disease progression in two large Phase 3 studies.
Though these studies were always seen as long shots, scientists have hypothesized that GLP-1 drugs may help treat neuro-degenerative diseases and improve cognition by reducing inflammation in the brain and protecting neurons. Just because Novo's studies failed doesn't mean studying GLP-1 drugs in Alzheimer's is a dead end, though pharma companies may be more reluctant to pursue this king of research.
Lon Schneider, an Alzheimer's researcher at the University of Southern California, told me that Novo should have conducted earlier clinical studies before jumping into its large Phase 3 trials, in order to better understand how much of the medication may have actually been getting into the brain and also to identify the best dosing regimen to use and which types of patients to target. Much of the real-world evidence that Novo was looking at, for example, was in patients with type 2 diabetes.
Schneider, who has consulted for Novo but was not involved in the trials, also said it's possible that a GLP-1 drug could be beneficial when combined with a different treatment or as a preventive drug.
No comments