ImmunityBio ($IBRX) received a delayed response from Wall Street today causing the stock to surge more than 50%. At one point this morning, IBRX was trading above 2$.
- ImmunityBio has recently completed its Biologics License Application (BLA) resubmission to the FDA, which was initiated after addressing concerns in a Complete Response Letter.
- The resubmission included updated data highlighting the extended duration of Complete Response (CR) in both BCG-unresponsive and BCG-naïve NMIBC patients. Significant findings were:
- In BCG-unresponsive NMIBC patients, a median duration of CR is yet to be reached, with responders being observed for over 28 months.
- Over 90% of responding BCG-unresponsive NMIBC patients have a likelihood of evading a cystectomy at or beyond 24 months.
- Long-term follow-up in BCG-naïve NMIBC patients showed a continued complete remission duration in all 6 patients available for tracking, with a median survival period of 8.8 years without the need for a cystectomy.
- The BLA supports the use of N-803 (Anktiva®), an innovative IL-15 superagonist, combined with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without other forms of the disease.
- N-803 is distinguished by its enhanced role in stimulating specific immune responses while avoiding unnecessary immune activations. It is presently being studied in two different clinical NMIBC trials.
- ImmunityBio, a clinical-stage immunotherapy company, specializes in the development of advanced therapies and vaccines to strengthen the natural immune response against cancer and infectious diseases.
For further details, refer to ImmunityBio’s official site: www.immunitybio.com