Posted Mar. 13, 2017 at 3:31 p.m.

Heat Bio reports positive results from early cancer drug trial

Published: 2017-03-13 15:31:56
Updated: 2017-03-13 15:31:56


Heat Biologics, a Durham company developing immunotherapies to fight cancer, has reported positive results from a Phase 1b trial of its combination treatment for non-small cell lung cancer.

The company’s announcement that it achieved a desirable efficacy endpoint was especially good news for Heat, which saw its stock price slammed after it reported less-positive results for its bladder cancer treatment late in 2016.

The latest trial evaluated Heat’s HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo). The treatment did not show additional toxicity from the combination, and five of 15 patients treated had 20 percent or more tumor reduction.

The data monitoring committee concluded that the positive safety profile, mechanistic evidence and encouraging signs of synergistic efficacy warranted expansion to a Phase 2 trial.

“We are encouraged by the results from this Phase 1b trial evaluating the therapeutic vaccine, HS-110, combined with the checkpoint inhibitor, nivolumab, in patients with advanced non-small cell lung cancer,” said Daniel Morgensztern, M.D., associate professor of medicine and director of thoracic oncology, Washington University School of Medicine, in a Heat news release.

“We continue to see that the combination appears to be generally well-tolerated, and the encouraging signs of efficacy warrant a larger sample size. We’ve seen some patients with increased tumor infiltrating lymphocytes (TIL) after treatment, and anticipate that we can confirm this trend in the Phase 2.”

Jeff Hutchins, Ph.D., Heat’s chief scientific officer and senior vice president of preclinical development, added, “We saw that those patients with increased levels of TIL at 10 weeks had a durable benefit, with six out of eight of these patients (75 percent) alive at the one-year follow-up point.

“We designed this trial with the Bristol-Myers Squibb Checkmate 057 nivolumab trial in mind, which reported a 19 percent response rate in a similar patient population. Although this is a small sample size and a non-randomized trial, we believe that this is an encouraging sign that the combination may be more effective than checkpoint therapy alone and could provide therapeutic benefit to a majority of lung cancer patients who do not respond well to checkpoint monotherapy. “

In a recent interview with the North Carolina Biotechnology Center, Heat CEO Jeff Wolf said, “Not only our technology, but any immunotherapy works best with other synergistic immunotherapies. So it’s not going to be one treatment, but multiple ones. We’re developing a portfolio of therapies that combine for a more lasting and sustained benefit against cancer.”

After Heat was founded in 2008, the North Carolina Biotechnology Center helped recruit the company to the state and provided Heat its first outside funding, a $225,000 Strategic Growth Loan. That opened doors to more investment opportunities. Heat was able to repay the loan well ahead of schedule as other investment support came in. NCBiotech also supported the company with its first offices in North Carolina, plus an internship and early business connectivity.

Heat stock (Nasdaq: HTBX) traded at $1.04, up 15 percent the day of the positive trial results announcement, but still well off its 52-week high of $3.35.

(C) N.C. Biotechnology Center

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