ImmunityBio shares jump on Anktiva resubmission hopes

Calfornian immunotherapy company ImmunityBio (Nasdaq: IBRX) has announced that it has held a Type B End-of-Phase meeting with the US Food and Drug Administration (FDA) regarding the company’s supplemental Biologics License Application (sBLA) for Anktiva (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors. 

ImmunityBio presented an overview of the clinical status of its papillary disease program, including more than five years of follow-up data supporting the papillary indication. 

Highlights included durable disease-specific survival of approximately 96% at 36 months, with the median survival not yet reached even with five years of follow-up, high rates of cystectomy avoidance of 92% and 82% at one and three years, respectively, and a safety profile consistent with the currently approved indication in CIS disease with or without papillary tumors.