ImmunityBio: Stocks Rise Following Bladder Cancer Trial Updates: Details

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

• Non-BCG-reactive papillary disease in the setting of NMIBC: ImmunityBio is preparing to submit a supplemental biologics license application (sBLA) in 2025 for its treatment targeting Bacille Calmette-Guérin (BCG) non-reactive NMIBC in the papillary indication. As published in the NEJM Chamie 2022 publication, the primary endpoint was met with a rate of 55% disease-free patients after 12 months, 51% after 18 months, and 48% after 24 months.
• Additionally, patients who received Anktiva + BCG achieved a 93% cystectomy avoidance rate with a median follow-up of 20.7 months.
• Source alternative de BCG : In collaboration with the Serum Institute of India, ImmunityBio plans to submit a regulatory application for an alternative source of BCG in the first quarter of 2025. The Serum Institute’s GMP production capacity to manufacture large-scale volumes of BCG, already tested for safety and effectiveness in clinical trials in Europe in subjects with NMIBC, aims to address the shortage of BCG.

Price movement: On Thursday, at its last score, IBRX stock jumped 18.6% to trade at $2.835.

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