ImmunyBiBio, Inc. announced it has completed the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for N-803 (Anktiva(R), a first-in-class IL-15 superagonist, plus Bacillus Calmette-Gurin (BCG) for the treatment of BCG- unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. The BLA is supported by the results of ImmunityBio's studies in bladder cancer including the pivotal QUILT-3.032 study (NCT03022825), published in NEJM Evidence(1) in November 2022. An update of the duration of response regarding the responders identified by the FDA in the efficacy population for BCG unresponsive subjects with high-risk CIS disease was provided in the BLA resubmission.

This update demonstrated a prolonged duration of remission in responding subjects, with a median duration of CR not yet reached with a follow-up in responders exceeding 28 months, and a safety profile as reported previously. The updated duration of CR in these responding BCG-unresponsive subjects showed that the probability of maintaining a CR for = 24 months was 60%, with a cystectomy free rate at = 24 months of over 90%. In addition, ImmunityBio provided an update on the long-term follow-up (QUILT-205) of subjects receiving N-803 plus BCG for CIS +/- Ta/T1 in the Phase 1b (QUILT-2.005) trial, examining the survival of the nine subjects entering the trial since 2014.

All 9 subjects (100%) achieved a complete remission and the results are published in Oncoimmunology(2-5). Of the nine subjects, two were deceased from causes other than bladder cancer and one was lost to follow-up. Of the 6 subjects available for follow-up (QUIL T-205), 6 out of 6 subjects (100%) demonstrated long-term complete remission with bladder preservation over a median survival period of 8.8 years and all 6 subjects have avoided a cystectomy to date.

ImmunityBio's IL-15 superagonist N-803 (Anktivine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. N-803 is a novel investigational IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor /IgG1 Fc fusion protein. Its proposed proposed proposed to be a novel investigational IL- 15 receptor /IgG1Fc fusion protein.

Its Proposed IL-15 receptor/IgG1 Fc Fusion protein. Its proposed proposed to be a first-in-classIL-15 superagonist (IL-15) in the Phase 1b) and BCG-nave patients demonstrated a prolonged duration of complete remission exceeding over 2 years in the unresponsive cohort and over 8 years in the BCG-nave cohort.