ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced significant progress in its ongoing discussions with the U.S. Food and Drug Administration (FDA) 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 innovative treatment targeting Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication. As published in the Chamie 2022 NEJM1 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. This immunotherapy of rescuing BCG with ANKTIVA (nogapendekin alfa inbakicept-pmln), now approved in the CIS indication, represents a step towards providing therapeutic options in patients with BCG unresponsive NMIBC in papillary disease who currently have limited treatment choices and face radical total cystectomy (removal of bladder). The addition of the papillary indication could expand the potential patient population benefiting from this therapy and may allow patients to avoid the high morbidity and mortality associated with radical total cystectomy.

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, ensuring a reliable supply for patients in need. This initiative underscores ImmunityBio's commitment to addressing critical supply issues and expanding the opportunity for patients and physicians to have access to high quality and quantities of BCG to initialize and maintain treatments for bladder cancer, subject to regulatory approvals.

Second-Line and Third-Line NSCLC Patients Who Have Progressed on Checkpoint Inhibitors: A Phase 2b study (QUILT-3.055) included (N=86) NSCLC patients and demonstrated prolonged overall survival when ANKTIVA was combined with the same checkpoint inhibitors on which patients were progressing, validating the rescue potential of ANKTIVA for T cells and checkpoint inhibitors. Compared to the most frequently used chemotherapy docetaxel in this setting with overall survival ranging from 7 to 10 months and associated with high toxicities of this chemotherapeutic agent, ANKTIVA plus a checkpoint inhibitor represents an immunotherapeutic advance for this disease.

ImmunityBio plans to submit a Biologics License Application (BLA) in 2025 for second- and third-line treatment of patients with NSCLC, who are progressing on checkpoint inhibitors. As presented at the IASLC 2024 World Conference on Lung Cancer by Dr. Wrangle2, the QUILT-3.055 study (Phase 2b, N=86) has shown promising results demonstrating a median overall survival for all patients at 14.1 months. In PD-L1 negative subjects, the median overall survival extended to 15.8 months.

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