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FDA fast tracks HS-410 for nonmuscle-invasive bladder cancer
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The FDA today granted fast track designation to HS-410 for use in combination with Bacillus Calmette-Guérin immunotherapy for the treatment of nonmuscle-invasive bladder cancer, according to a press release from the drug’s manufacturer.
The development of HS-410 (Vesigenurtacel-L, Heat Biologics) — designed to generate killer T cells to attack cancers — is based on the company’s Immune Pan Antigen Cytotoxic Therapy (“imPACT”) platform.
“We are very pleased that the FDA has granted this important designation for HS-410,” Melissa Price, PhD, vice-president of clinical development and regulatory affairs of Heat Biologics, said in the release. “The decision underscores the unmet need for bladder cancer treatments and serves as an additional validation for our clinical program. Currently there are limited therapeutic treatment options available for this patient population, with no new treatments approved in this setting in over 30 years.”
HS-410 is currently being evaluated in a randomized phase 2 trial in combination with Bacillus Calmette-Guérin (BCG) immunotherapy and as monotherapy for nonmuscle-invasive bladder cancer.