(RTTNews) - ImmunityBio, Inc. (IBRX), a immunotherapy company, provided a regulatory update on its clinical development pipeline following discussions with the U.S. Food and Drug Administration or FDA.
The company is preparing to submit a supplemental Biologics License Application or sBLA in 2025 for its treatment targeting Bacillus Calmette-Guérin or BCG unresponsive non-muscle invasive bladder cancer or NMIBC in the papillary indication.
This therapy, which combines ANKTIVA with BCG, has shown promising results, including a disease-free rate of 55% at 12 months and 93% cystectomy avoidance in patients with NMIBC.
The treatment offers hope to patients who currently have limited options and face the prospect of radical cystectomy.
ImmunityBio is also planning a regulatory submission for an alternative source of BCG in Q1 2025 in collaboration with the Serum Institute of India.
This initiative aims to address the global shortage of BCG, ensuring a reliable and high-quality supply for NMIBC treatment.
The Serum Institute's GMP capacity and its prior clinical safety and efficacy testing in Europe support this move.
In the non-small cell lung cancer or NSCLC space, ImmunityBio is preparing to submit a Biologics License Application or BLA in 2025 for second- and third-line treatment of patients who have progressed on checkpoint inhibitors.
The company's ongoing Phase 3 trial (ResQ201A-NSCLC) builds on promising Phase 2b data from the QUILT-3.055 trial, which demonstrated improved overall survival in NSCLC patients with limited treatment options.
ANKTIVA, a first-in-class IL-15 receptor agonist, is central to ImmunityBio's approach to rescuing T cell and NK cell activity and overcoming tumor resistance, which could significantly benefit cancer patients who have failed prior treatments.
ImmunityBio remains committed to advancing cancer immunotherapies and addressing unmet medical needs in bladder and lung cancer, with ongoing work to expand the potential of ANKTIVA and other immunotherapeutic approaches.
Currently, IBRX is trading at $2.84 up 19.03%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
