By Gabrielle Masson – Fierce Biotech News
Athenex is in a tight spot, trying to stretch out its remaining cash and ward off an unruly creditor just as the FDA slaps a clinical hold on its neuroblastoma cell therapy while it explores a patient’s death in a phase 1 trial.
The New York-based oncology company announced a “recent FDA-imposed clinical hold” for a phase 1 study evaluating its autologous GD2 CAR-NKT cell therapy for patients with relapsed or refractory high-risk neuroblastoma, in its latest earnings release this morning.
The hold is tied to the death of a “young, heavily pretreated male patient” who received a 300 million cells/m2 dose three weeks after CAR-NKT cell therapy administration. The study, which aimed to enroll 36 patients, was underway at Baylor College of Medicine (BCM) at Texas Children’s Hospital in Houston.