The U.S. Food and Drug Administration has granted fast track status to Altor Bioscience‘s ALT-803 in combination with bacillus Calmette-Guérin (BCG) for the treatment of patients with non-muscle invasive bladder cancer (NMIBC).
The FDA’s fast track program is meant to accelerate the development and review of therapies that treat serious conditions and fill unmet medical needs.
“We are thrilled that the FDA has granted Fast Track designation for ALT-803 in NMIBC. This is a key milestone for advancing our NMIBC program,” Hing C. Wong, PhD, the CEO of Altor BioScience, said in a press release.
“Patients with NMIBC have few treatment options and there is a significant unmet medical need for novel therapies in NMIBC, particularly in patients who are unresponsive to BCG,” Wong said. “We are looking forward to working closely with FDA to facilitate our clinical program in this important indication.”
The interleukin-15 (IL-15) protein is a naturally occurring molecule in the body that induces proliferation of natural killer cells, and that enhances the anti-tumor immunity of cytotoxic T-cells.
ALT-803 is an investigational IL-15 agonist complex with better pharmacokinetic properties, longer persistence, and higher anti-tumor activity compared to the native IL-15 molecule.
Preclinical studies have shown that it can mobilize immune cells, eliciting rapid and durable responses against several cancer types and virally-infected cells. This suggests that ALT-803 could be used in combination with targeted treatments and vaccines.
Currently, ALT-803 is being investigated in a Phase 1b/2 trial (NCT02138734) in combination with BCG in NMIBC adult patients who have not received prior BCG. Findings from the recently completed Phase 1b part of the trial will be presented at the American Urological Association Annual Meeting on May 12 in Boston. The Phase 2 part is currently recruiting participants.
Another Phase 2 trial (NCT03022825) is studying intravesical ALT-803 in combination with BCG in adult NMIBC patients who failed to respond to BCG treatment.
The FDA’s designation will now accelerate the clinical development of ALT-803 in combination with BCG for the treatment and prevention of carcinoma in situ, an invasive form of cancer that has not spread from its original place, of the urinary bladder. It will also be developed as prophylaxis for early stage papillary tumors following transurethral resection in NMIBC patients.