ImmunityBio secured five U.S. patents covering the combination of ANKTIVA with BCG in NMIBC, extending franchise protection through at least 2035 and reinforcing its bladder cancer commercialization strategy.
By: Regulatory Desk
ImmunityBio announced that the U.S. Patent and Trademark Office has issued five patents covering the combination of ANKTIVA with Bacillus Calmette-Guérin (BCG) in non-muscle invasive bladder cancer (NMIBC), extending protection through at least 2035.
The portfolio secures multiple elements of the ANKTIVA + BCG platform, including treatment compositions, intravesical dosing regimens, two-vial commercial kits, and methods for both BCG-unresponsive and BCG-naïve NMIBC. It also protects the FDA-approved regimen and supports the company’s pending supplemental biologics license application (sBLA) for papillary-only disease.
The update coincides with ImmunityBio’s ongoing Phase 3 QUILT-2.005 trial evaluating ANKTIVA + BCG versus BCG alone in BCG-naïve carcinoma in situ. In parallel, the company signed an exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo-172 strain, potentially expanding U.S. BCG supply.
ImmunityBio said the expanded patent estate reinforces its bladder cancer immunotherapy franchise as it advances commercialization and clinical development efforts.
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