ImmunityBio Stock Trading Higher On Updates From Bladder Cancer Trials: Details

Core Insights - ImmunityBio, Inc. is advancing discussions with the FDA regarding its clinical development pipeline for non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC) [1] Group 1: NMIBC BCG Unresponsive Papillary Disease - The company is preparing to submit a supplemental Biologics License Application (sBLA) in 2025 for its treatment targeting BCG unresponsive NMIBC in the papillary indication [4] - The primary endpoint was met with a disease-free rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months, as published in the Chamie 2022 NEJM publication [4] - Patients receiving Anktiva+BCG achieved a 93% avoidance of cystectomy with a median follow-up of 20.7 months [4] Group 2: 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 [4] - The Serum Institute's GMP capacity to manufacture large-scale volumes of BCG has already been tested for safety and efficacy in clinical trials in Europe for subjects with NMIBC [4] - This initiative aims to address the shortage of BCG [4]