On Wednesday, ImmunityBio, Inc. (NASDAQ:IBRX) released progress in its ongoing FDA discussions regarding three areas of its clinical development pipeline in non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC).

• NMIBC BCG Unresponsive Papillary Disease: ImmunityBio is preparing to submit a supplemental Biologics License Application (sBLA) in 2025 for its treatment targeting Bacillus Calmette-Guérin (BCG) unresponsive NMIBC in the papillary indication. As published in the Chamie 2022 NEJM publication, the primary endpoint was met with a disease-free rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months.
• In addition, patients receiving Anktiva+BCG achieved a 93% avoidance of cystectomy with a median follow-up of 20.7 months.
• Alternative Source of BCG: In collaboration with the Serum Institute of India, ImmunityBio plans a regulatory submission for an alternative source of BCG in the first quarter of 2025. Serum Institute’s GMP capacity to manufacture large-scale volumes of BCG, already tested for safety and efficacy in clinical trials in Europe in subjects with NMIBC, aims to address the shortage of BCG.