FDA Approves ImmunityBio's BCG Alternative for Bladder Cancer Treatment

ImmunityBio has received a significant nod from the US Food and Drug Administration (FDA) to extend its expanded access programme. This initiative is aimed at providing an alternative source of Bacillus Calmette-Guerin (BCG), a crucial treatment for bladder cancer, addressing the ongoing scarcity of Tice BCG. The shortage of Tice BCG, a live cultured preparation of the BCG strain derived from Mycobacterium bovis, has been a substantial hurdle in treating patients effectively.

A recent survey conducted by Sermo revealed that over half of the US urologists faced challenges in treating patients in the past year due to the unavailability of Tice BCG. To counter this, the Serum Institute of India has developed a promising alternative, rBCG, which has delivered encouraging results in European clinical trials. This version has demonstrated robust immunogenic properties, particularly in stimulating CD8+ and CD4+ T cells, and offers an improved safety profile compared to earlier iterations of BCG.

Dr. Patrick Soon-Shiong, the founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, emphasized the collaboration with the FDA and the Serum Institute of India. He noted that this partnership is pivotal in ensuring a stable supply of this essential drug for bladder cancer patients, highlighting ImmunityBio’s dedication to overcoming critical challenges in patient access to necessary treatments.

In a strategic move in May 2024, ImmunityBio entered into an exclusive global agreement with the Serum Institute of India. This agreement secures the supply of the BCG vaccine for all cancer types, marking a significant step in addressing the global demand for effective cancer treatments. The company also holds several patents regarding the composition and application of BCG combined with Anktiva specifically for bladder cancer treatment.

BCG, originally formulated as a live vaccine for tuberculosis (TB) and first used in 1921, has been administered to over four billion people worldwide. Since 1977, BCG has been the standard treatment for non-muscle invasive bladder cancer (NMIBC), helping to induce an immune response that can potentially clear cancer cells.

The alternative rBCG has undergone genetic enhancements to boost its immunogenicity and safety. It has successfully completed Phase I/II human trials in Europe, functioning as an immunotherapy for individuals with NMIBC. The trials indicated that the safety profile of rBCG is comparable to that of a placebo, with a notable reduction in adverse events.

This development represents a significant advancement in the availability and effectiveness of bladder cancer treatments. By ensuring a reliable supply of rBCG, ImmunityBio is poised to make a substantial impact on the treatment landscape for bladder cancer, addressing both supply issues and improving patient outcomes.