ImmunityBio has gained US Food and Drug Administration (FDA) authorisation for an expanded access programme to supply an alternative source of Bacillus Calmette-Guerin (BCG) to treat bladder cancer.
The development comes in response to significant supply shortages of Tice BCG [an attenuated, live culture preparation of the BCG strain of Mycobacterium bovis] which have been a major barrier to treatment.
Go deeper with GlobalData
In a survey of US urologists by Sermo, more than half reported an inability to treat subjects in the past 12 months due to the lack of access to Tice BCG.
The Serum Institute of India-developed alternative BCG (rBCG) source has shown promising outcomes in European clinical trials, demonstrating potent immunogenicity with cluster of differentiation 8+ (CD8+) and CD4+ T cell stimulation and enhanced safety compared to previous BCG strains and formulations.
ImmunityBio founder, executive chairman and global chief scientific and medical officer Dr Patrick Soon-Shiong stated: “Our collaboration with the FDA and Serum Institute to ensure a reliable supply of this vital drug for bladder cancer patients underscores ImmunityBio’s commitment to addressing critical access issues that affect so many patients.”
In May 2024, ImmunityBio entered an exclusive global agreement with the Serum Institute of India to obtain a supply of the BCG vaccine for all types of cancer.
The company holds several patents for the composition and use of BCG combined with Anktiva in bladder cancer treatment.
The rBCG vaccine, originally developed as a live vaccine against tuberculosis (TB), has been used since 1921 and administered to more than four billion individuals globally.
For non-muscle invasive bladder cancer (NMIBC) patients, BCG has been the standard of care since 1977, inducing an immune response that can lead to cancer clearance.
The rBCG has undergone genetic modifications to enhance its immunogenicity and safety. It has completed Phase I/II human trials in Europe as an immunotherapy for NMIBC subjects, showing a safety profile similar to placebo and reduced adverse events.
