Turning Up the Heat

Heat Biologics has come a long way in a short time.

But the most recent part of that journey is just a few miles down the road, to the biopharmaceutical company’s new Durham headquarters and lab facility on Capitola Drive. That move will be celebrated in a July open house.

Heat was founded in 2008 to commercialize a new way to fight multiple kinds of cancers, discovered at the University of Miami. CEO Jeff Wolf soon decided Miami wasn’t the right environment to build the company, however, and embarked on a scouting expedition.

After he met with specialists at the North Carolina Biotechnology Center, the hunt was over. Wolf said he knew he could get the talent and support he needed in North Carolina to build Heat into a successful biopharmaceutical company. He moved his family to Durham and himself into a temporary office at NCBiotech in 2011.

Getting ready for the big time

Professionals in NCBiotech’s Business and Technology Development group worked closely with Wolf to help hone his pitch to investors. He also joined them and CEOs of other life science start-ups on NCBiotech-led visits to venture capital companies in Palo Alto and Boston.

Wolf had one employee in late 2011 when he secured his first funding from NCBiotech, a $225,000 Strategic Growth Loan. That flipped a funding switch. Heat was able to repay the loan well ahead of schedule as other investment support came in.

Heat got another boost from one of NCBiotech’s $3,000 industrial intern awards in 2012, to help it reach the public-trading milestone of an initial public offering of stock on the NASDAQ exchange. By the time of the IPO offering of 2.5 million shares at $10 apiece, Heat had also garnered some $5 million in other outside investment.

First two drug candidates in pipeline

Heat has already filed two investigational new drug (IND) applications with the U.S. Food and Drug Administration. The first, for HS-110, will soon be entering Phase 2 trials against non-small cell lung cancer.

The second, filed in December 2013, was for HS-410, a bladder cancer therapy. The company recently expanded that Phase 1 / 2 trial, after the first three patients had no serious side effects. Eventually Heat plans to enroll 93 patients to try its ImPACT Therapy after surgery.

The Phase 1 portion evaluates the safety of two doses of HS-410 in bladder cancer patients. Phase 2 evaluates the effectiveness of a vaccination with HS-410 in extending the time of disease recurrence compared to placebo.

"We are delighted about the early reports of the safety of HS-410," said Wolf. "This early data appears to be consistent with the data from our successful Phase 1 lung cancer trial with our product candidate HS-110 (Viagenpumatucel-L) based on the same ImPACT platform."

ImPACT Therapy is designed to deliver live, genetically modified, irradiated human cells which are reprogrammed to pump out a broad spectrum of substances toxic to cancer cells. ImPACT is a one-two punch that also includes a potent immune-system booster called gp96, a protein found in all human cells. Heat taps gp96 to educate and activate cancer patients’ own immune systems to better recognize and kill cancerous cells.