The U.S. FDA has given Prokarium the green light for its lead program in non-muscle invasive bladder cancer, marking a milestone for an underserved population of bladder cancer patients.
The agency approved the London-based company’s IND application for its experimental immunotherapy, ZH9, enabling initiation of the clinical development program in the U.S. ZH9 is a novel microbial immunotherapy based on live-attenuated Salmonella enterica Typhi strain.
Currently, microbial immunotherapy, in the form of intravesical Bacillus Calmette-Guérin (BCG), is the standard-of-care for non-muscle invasive bladder cancer, but the drug's sole manufacturer — Merck — cannot keep up with demand.
“The urgent and continuous need to prevent bladder cancer recurrence, especially given the ongoing shortage of BCG, the standard treatment option for high-risk patients, makes the development of innovative alternatives a matter of importance,” said Dr. Sam Chang, chief surgical officer at the Vanderbilt Ingram Cancer Center, in a Prokarium press release.
Prokarium will begin enrolling patients in the PARADIGM-1 study in the first half of 2024 across multiple centers in the U.S.
At the same time, Prokarium also announced that it is strengthening its leadership team with the appointment of Dara Henry, Ph.D., as chief operating officer.