ImmunityBio, Inc. (NASDAQ: IBRX) submitted a Biologics License Application (BLA) for its antibody cytokine fusion protein as a therapy for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 illness to the FDA for evaluation. ImmunityBio, a premier clinical-stage immunotherapy startup, submitted the BLA based on encouraging findings from a number of trials, including the current QUILT 3.032 study. The anticipated action date for the Prescription Drug User Fee Act (PDUFA) is May 23, 2023.

This combination of N-803 and BCG is ImmunityBio’s first BLA to be accepted for consideration by the FDA. This is a significant step forward in ImmunityBio’s ambition of revolutionizing cancer treatment by stimulating the patient’s innate immune system rather than using high-dose chemotherapy. N-803 with BCG, if authorized, would be the first immunotherapy combination for this indication in 23 years that can be administered directly to the bladder (intravesically) to activate natural killer cells and T cells. It is a critical milestone in the clinical proof of ImmunityBio’s creator, Patrick Soon-Shiong, M.D.’s theory of “Quantum oncotherapeutics: a longitudinal spatiotemporal orchestration towards immunogenic cell death.”

N-803 has a distinct method of action that promotes the growth of NK and T cells, which are adaptive and innate immune system cells. Through this mechanism, N-803 augments the immune response elicited by BCG for bladder cancer or a checkpoint inhibitor for other reasons. In the QUILT 3.032 research, 71% of patients who had failed previous treatments exhibited a more than 50% increase in both response and median duration when compared to the FDA-approved alternatives Valrubicin and Pembrolizumab, both of which are systemic checkpoint inhibitor medicines for this indication.

ImmunityBio’s Executive Chairman and Global Chief Scientific and Medical Officer, Patrick Soon-Shiong said that this BLA approval brings them one step closer to being able to offer this promising combination therapeutic to more people living with NMIBC and, ultimately, reduce the incidence of cystectomies. This is an illustrative example of the possibility of creating trained innate immunological memory to produce long-term, persistent benefits against major, life-threatening illnesses.