Genetic Engineering in the Press by GEG

The FDA has approved lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) as a new chimeric antigen receptor (CAR) T-cell therapy for adults with relapsed or refractory large B-cell lymphoma (R/R LBCL).

Josiah Zayner has made glow in the dark boo with a do-it-yourself DNA kit that his startup, the Odin, has just started selling online. The company conceived it as a gimmick to introduce homebrewers to genetic engineering. But in the short time the kit’s been for sale, it’s also become a test for the citizen scientists to see how far they can push the FDA.

In September, the U.S. Food and Drug Administration suspended the Phase 1 trial evaluating Cellectis' investigational CAR T-cell therapy, UCARTCS1A, for the treatment of multiple myeloma for safety reasons after a patient who received the second lowest dose of the therapy died of cardiac arrest. UCARTCS1 cells are modified to carry an artificial receptor that targets the SLAMF7, or CS1, protein found at high levels on the surface of myeloma cells. The modified cells are developed in the laboratory and then infused into the patient to help fight the cancer. Cellectis has worked closely with the regulatory agency to meet its requirements and has modified the clinical protocol to increase patient safety. Recently, the FDA lifted the suspension of the Phase 1 trial for the UCARTCS1A CAR T cell therapy. The trial intends to recruit a total of 18 participants between the ages of 18 and 64 years at three sites in the United States: MD Anderson Cancer Center, Texas; Hackensack Meridian Health, New Jersey; and Weill Cornell Medicine, New York. To be eligible for the study, patients must have a confirmed diagnosis of active multiple myeloma and have relapsed after previous treatment.