He’s not a track coach, but Jeff Wolf is leading a hard-running team on a sprint that could bring more than Olympic gold.

Wolf, the CEO of Durham cancer chaser Heat Biologics, has been traversing the country telling investors, analysts and regulators why his company’s oncology platform deserves their attention.

And he’s getting some traction. Only two months ago, the U.S. Food and Drug Administration issued a coveted fast track designation for the company’s immune therapy, code named HS-410 (Vesigenurtacel L), targeting bladder cancer.

The designation means that the FDA will take a range of actions to work more closely with Heat to speed the review process, in the belief that Heat might be developing a platform technology that can save lives and reduce suffering, initially in people with so-called non-muscle invasive bladder cancer.

Now the company is starting a new phase one-b trial of its other lead product, Viagenpumatucel-L (HS-110) to treat non-small cell lung cancer. Heat expects to enroll the first patient shortly in this new trial combining HS-110 with multiple immune modulating strategies.

Making an ImPACT

The therapies are based on the company’s Immune Pan Antigen Cytotoxic Therapy (ImPACT) platform. The company believes it’s a platform technology because early testing indicates it can coax the body’s own immune defense weapons, called killer T cells, to attack numerous forms of cancer.

HS-110 is Heat’s first product candidate in its series of ImPACT drugs. And HS-410 is already in phase two clinical trials, which evaluate its effectiveness as a vaccination in extending the time of disease recurrence compared to placebo.

Heat was founded in 2008 to commercialize the cancer-fighting approach discovered at the University of Miami. Wolf soon decided Miami wasn’t the right environment to build the company, explored several major biotech hubs, and picked the Research Triangle area after meeting with specialists at the North Carolina Biotechnology Center.

Wolf said NCBiotech convinced him he could get the talent and support he needed in North Carolina to build Heat into a successful biopharmaceutical company, so he moved his company, consisting of himself and one employee, into a temporary rental office at NCBiotech in 2011.

NCBiotech helped propel company’s growth

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.

NCBiotech provided Heat its first outside funding, a $225,000 Strategic Growth Loan. That opened doors to more investment opportunity for Wolf. 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.

Heat’s 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.