Heat Biologics Reports Positive Interim Results From Cancer Trial

Durham-based Heat Biologics just got a little hotter.

The clinical-stage biopharmaceutical company reported positive interim results from a phase 2 clinical trial of its therapy to treat advanced non-small cell lung cancer (NSCLC).

Heat said the drug, HS-110 – used in combination with Bristol-Myers Squibb’s immune checkpoint inhibitor, OPDIVO – provided “substantial survival benefit” in a group of  previously treated, checkpoint inhibitor naïve patients with advanced NSCLC. HS-110 is a cell-based therapy that activates patients’ immune systems to fight tumor cells.

The median progression-free survival rate in this group of trial participants was 1.8 months, with a median overall survival rate of 24.6 months, according to Heat.

A second group of patients previously treated with a checkpoint inhibitor, whose disease had advanced, had a median progression-free survival of 2.8 months and a median overall survival of 11.9 months. 

The company said approximately 200 patients have received HS-110 to date, with no treatment-related serious adverse events. The combination of HS-110 and OPDIVO were well tolerated.

“We are thrilled to report this latest positive survival data from our phase 2 trial of HS-110, in combination with Bristol-Myers Squibb’s OPIDVO (nivolumab), in advanced non-small cell lung cancer demonstrating HS-110’s broad potential for providing multiple treatment options to NSCLC patients,” said Jeff Wolfe, Heat Biologics’ CEO. “We are currently evaluating possible phase 3 registration pathways for HS-110 in combination with a checkpoint inhibitor and intend to review these plans with the U.S. Food and Drug Administration, as well as potential partners.”

HS-110 and another Heat drug, HS-410, use the company’s Immune Pan Antigen Cytotoxic Therapy (ImPACT) platform. These drugs coax the body’s own immune defense weapons, called T cells, to attack numerous forms of cancer. 

ImPACT Therapy delivers live, genetically modified and irradiated human cells programmed to pump out a broad spectrum of substances toxic to cancer cells. ImPACT also incorporates a second line of defense, a potent immune-system booster called gp96 that is a protein found in all human cells. Gp96 educates and activates cancer patients’ own immune systems to better recognize and kill cancerous cells.

Heat also is using the gp96 platform to develop a vaccine that tackles COVID-19 by triggering the human immune response to attack the coronavirus and then protect against its reoccurrence. The vaccine is in preclinical development.

Heat was formed in 2008 to commercialize the cancer-fighting approach discovered at the University of Miami. Wolf moved his company from Florida to  North Carolina in 2011, initially into a temporary rental office at the North Carolina Biotechnology Center. 

NC Biotech provided Heat with its first outside funding, a $225,000 Strategic Growth Loan, and followed up later with a  $3,000 industrial intern award in 2012.