Pfizer's BCMA/CD3 Bispecific Candidate Study Derailed Amid Safety Woes

Pfizer Inc PFE has paused enrollment in a pivotal trial of its anti-BCMA bispecific antibody after seeing three cases of peripheral neuropathy in an earlier-stage study.
In February, Pfizer took its BCMA bispecific elranatamab, also known as PF-06863135, into a pivotal Phase 2 study on the strength of the 80% overall response rate it saw in 20 patients treated in Phase 1.
The pause was triggered by the discovery of three cases of peripheral neuropathy in the Phase 1 trial.
Pfizer disclosed the BCMA setback as part of a first-quarter update that also covered the status of its DMD gene therapy fordadistrogene movaparvovec, formerly known as PF-06939926.
Dosing in a phase 3 trial of the gene therapy began at ex-U.S. sites late last year.
However, Pfizer is yet to get the green light to start dosing at U.S. sites and does not expect to do so in the first half of 2021.
The first-quarter update also brought news of the discontinuation of two projects. Pfizer is stopping work on IL-10 drug Dekavil in ulcerative colitis, and JAK3/TEC inhibitor ritlecitinib in rheumatoid arthritis.
Price Action: PFE shares are up 0.32% at $39.70 during the market session on the last check Tuesday.

Overview Rating:

Speculative

0100