HS-410 Plus BCG Receives Fast Track Designation for Invasive Bladder Cancer

Clinicians in the not too distant future may have a new tool for treating bladder cancer. The US Food and Drug Administration (FDA) on March 9, 2015, granted fast track designation for HS-410 (vesigenurtacel-L) for the treatment of non-muscle invasive bladder cancer (NMIBC). This novel therapy is being developed by Heat Biologics, Inc., and is based on its cutting-edge Immune Pan Antigen Cytotoxic Therapy ("ImPACT") platform that is designed to generate killer T-cells to attack cancers.

Currently, a phase II clinical trial is being performed in combination with the standard of care, which is intravesical immunotherapy with the biological response modifier Mycobacterium bovis bacillus Calmette-Guérin (BCG therapy). Heat Biologics reports that BCG may work synergistically with HS-410, since BCG promotes trafficking of HS-410 activated cytotoxic T-cells into the bladder endothelium.

Heat's Vice President of Clinical Development and Regulatory Affairs, Melissa Price, PhD, said the company is very pleased that the FDA has granted this important designation for HS-410. The decision underscores the unmet need for bladder cancer treatments and serves as an additional validation of the company’s clinical program. She said currently there are limited therapeutic treatment options available for NMIBC patients. Dr. Price noted there have been no new treatments approved for NMIBC patients in decades. BCG therapy for the past 30 years has been the most effective tool for preventing local recurrences and tumor progression in NMIBC patients.

The advantages of fast track designation include actions to expedite development as well as opportunities for frequent interactions with the FDA review team. Currently, bladder cancer is the fifth most common cancer in the US, with approximately 75,000 new cases in 2014 and 16,000 deaths, according to the American Cancer Society. About 75% of the newly diagnosed patients have NMIBC, and these patients tend to have very high recurrence rates. Yet, there are limited treatment options following recurrence.

A phase II clinical trial is ongoing with HS-410 plus BCG therapy with a primary endpoint of recurrence-free survival. Complete enrollment for the study is expected in the third quarter of 2015.