With Merck & Co. largely propping up supplies of the bladder cancer-fighting bacteria Bacillus Calmette-Guérin (BCG) in the U.S., ImmunityBio has received the FDA all-clear to help pick up the slack—and provide a boost to its new immunotherapy Anktiva along the way.
The FDA has authorized ImmunityBio’s expanded access program (EAP) to bring an alternative source of BCG to the U.S., the company said Wednesday.
BCG, in use since 1921 and originally developed as a live vaccine against tuberculosis, also forms a key part of the non-muscle invasive bladder cancer (NMIBC) armamentarium. NMIBC accounts for roughly 80% of an estimated 80,000 new bladder cancer diagnoses each year in the U.S.
From 2012 until last April—when ImmunityBio won its first U.S. approval for Anktiva plus the BCG vaccine in certain NMIBC patients—Merck’s TICE BCG stood alone as the sole BCG product in the U.S. For much of that time, Merck was also the country’s only supplier of the bacteria-based biologic.
Even without factoring Anktiva into the equation, shortages of Merck’s TICE BCG have already put up a “significant impediment” to bladder cancer treatment in the U.S., ImmunityBio said in a release. The company cited results from a recent Sermo survey which found that 57% of 100 U.S. urologists couldn’t treat patients in the past 12 months thanks to hamstrung TICE BCG access.
Merck is certainly aware of the problem and sought to remedy the situation by announcing plans in late 2020 to construct a new TICE BCG plant in North Carolina. Early last year, the New Jersey drug giant said it expected the capacity-tripling facility to be complete by “late 2025 to late 2026.”
Prior to 2012, Merck only accounted for around 30% to 40% of the overall TICE BCG supply in the U.S. But, after other manufacturers left the market, the company responded by moving to increase its own production capacity.
The prevailing supply issue—despite BCG’s prevalence as a global vaccine—comes down to the manufacturing complexities needed to crank out a biologic using benign bacteria, ImmunityBio explained in Wednesday’s release.
Recognizing the supply squeeze on the horizon following Anktiva’s approval, ImmunityBio in May 2024 enlisted vaccine juggernaut the Serum Institute of India for large-scale production of BCG to be used with the company’s IL-15 bladder cancer drug.
ImmunityBio continues to rely on SII as the alternative BCG source identified in the FDA’s expanded access program.
Specifically, the partners will now be supplying the U.S. with recombinant BCG, which carries two gene modifications designed to improve immunogenicity and safety versus earlier strains and formulations, ImmunityBio explained.
“With the increasing threat of supply shortages of essential medicines, the biopharmaceutical industry must innovate and secure new means of ensuring uninterrupted access to vital therapeutics,” Patrick Soon-Shiong, M.D., ImmunityBio’s founder and chief scientific and medical officer, said in a statement.
“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,” he continued.
Supplies of the therapeutic are available now, with shipments set to kick off immediately through the FDA’s access program, ImmunityBio said.