Heat Biologics, Inc. receives FDA approval for HS-410 Treatment of Bladder Cancer

According to the American Cancer Society, bladder cancer is the fifth most common cancer in the US with approximately 75,000 new cases in 2014 and 16,000 deaths. About 75% of the newly diagnosed patients have NMIBC. A key issue for bladder cancer is the high rate of recurrence, for which limited treatment options are available beyond complete bladder removal. Heat Biologics is examining candidate HS-410 in conjunction with standard treatment to stimulate the immune system and eliminate remaining cancer cells to prevent recurrence. The Company completed enrollment in a Phase 1 study and is expected to release interim data on 10 patients in the first half of 2015. A Phase 2 clinical trial is ongoing with a primary endpoint of recurrence-free survival. Heat is expected to complete enrollment in the Phase 2 study in the third quarter of 2015, which would make topline data available in the second half of 2016.
"We are very pleased that FDA has granted this important designation for HS-410," said Melissa Price, Ph.D., Heat's Vice President of Clinical Development and Regulatory Affairs. "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."

"We are very pleased that FDA has granted this important designation for HS-410," said Melissa Price, Ph.D., Heat's Vice President of Clinical Development and Regulatory Affairs. "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." - See more at: http://globenewswire.com/news-release/2015/03/09/713474/10123736/en/Heat-Biologics-Inc-Receives-US-FDA-Fast-Track-Designation-for-HS-410-Vesigenurtacel-L-in-Combination-With-BCG-for-the-Treatment-of-Non-Muscle-Invasive-Bladder-Cancer.html#sthash.z1W3nsFh.dpuf

"We are very pleased that FDA has granted this important designation for HS-410," said Melissa Price, Ph.D., Heat's Vice President of Clinical Development and Regulatory Affairs. "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." - See more at: http://globenewswire.com/news-release/2015/03/09/713474/10123736/en/Heat-Biologics-Inc-Receives-US-FDA-Fast-Track-Designation-for-HS-410-Vesigenurtacel-L-in-Combination-With-BCG-for-the-Treatment-of-Non-Muscle-Invasive-Bladder-Cancer.html#sthash.z1W3nsFh.dpuf