Biotechnology company Heat Biologics believes the kinds of cancer drugs it is developing are part of a rising wave of immunotherapies now making headway in clinical studies.

Immunotherapy is “on the cusp of great industry breakthroughs” and several approval applications are expected to be filed whit the Food and Drug Administration in coming years, the company said in a corporate presentation filed with securities regulators. Heat identifies Biovest International, GlaxoSmithKline and Bavarian Nordic among those expected to file for regulatory approval for new immunotherapies.

Heat Bio hopes its investigative cancer treatments will join them. Heat plans to do more clinical work this year on its cancer immunotherapies but first it must make its case to prospective investors; the company is counting on funds from an initial public stock offering to finance additional clinical trials.

Chapel Hill-based Heat disclosed its IPO plans in May. The company has set a range of $10-$12 per share. At the midpoint the company would raise $18.2 million, which would be used to finance clinical studies on its two most advanced pipeline candidates: HS-110 for lung cancer and HS-410 for bladder cancer. The company also notes that it is researching treatments in breast and ovarian cancers. Clinical studies for those additional cancer treatments might not be funded from the IPO but Heat Bio is making a case as much for its technology as a platform for addressing multiple cancers while it also touts the potential of  individual therapeutic candidates. 

Heat’s “ImPACT”

Heat has developed a way to prompt a patient’s own immune system to fight cancer. Its proprietary technology is dubbed “ImPACT,” which stands for Immune Pan-Antigen Cytotoxic Therapy. ImPACT works by genetically modifying cancer cells so they release a protein called gp96. This protein triggers the body to fight cancer cells by mobilizing the patient’s own T cells, the cells that play a key role in an immune response. Called to action, the killer T cells then go out and destroy the tumor cells. Heat licensed the ImPACT technology from the University of Miami, where it was invented by Dr. Eckhard Podack, a professor of microbiology and immunology and medicine and chairman of the Department of Microbiology at the university’s medical school.

The key part of ImPACT is its action on the gp96 protein. This so-called heat shock protein is part of all human cells but it is only released from the cell when it dies. The ImPACT technology “severs the leash” that links that protein to the cell, Heat explains in its presentation. As a result, the tumor cell continually releases the gp96 protein that triggers the immune response. These modified tumor cells are then mass produced. But they are also irradiated so that when they are injected into the patient, they don’t replicate.

Heat refers to gp96 as the immune system’s “Swiss army knife” because of its versatility. Vaccines typically target just one antigen. But Heat’s technology will trigger a response to an array of antigens and could work on a variety of cancers, hence the “pan antigen” part of the technology’s name. Heat believes that the technology has applications not only in cancer, but also infectious diseases such as hepatitis C, malaria and HIV. Clinical work on applications of the technology in HIV are already underway, that work funded by the National Institutes of Health.

Fewer side effects

Heat says ImPACT offers the potential of treating cancer with fewer side effects than chemotherapy. Personalized medicine treatments, which also aim to reduce side effects, are emerging to treat cancer. But Heat believes its technology will have advantages over these therapies. Personsalized therapeutic vaccines require a sample of blood or cancer tissue from each individual patient. Heat’s ImPACT doesn’t require anything to be extracted from the patient. That’s an important differentiator. While personalized medicine offers the promise of a treatment tailored to work specifically to the individual, it’s the “personal” part of personalized medicine that takes a lot of time and costs a lot of money. Instead, Heat uses a master cell line to mass-produce a vaccine that could be used for all patients with a particular cancer type. This “off the shelf” technology cuts down on the costs of Heat’s immunotherapy.

HS-110, Heat’s immunotherapy candidate for non-small cell lung cancer, showed no serious adverse events in a phase I clinical trial of 18 patients. The data also suggest that the therapy increased patient survival. IPO proceeds would be used to take HS-110 through phase II clinical trials. The proceeds would also finance a combined phase I and II trial of HS-410 in bladder cancer.

Heat says it expects to hit multiple milestones in the next 12 to 24 months. Those milestones would be key to getting the financial support to take the experimental therapy into phase III studies or even a partnership with a large pharmaceutical company.

Big pharma has already demonstrated an appetite for acquiring immunotherapies. GlaxoSmithKline in May shelled out $325 million to acquire privately-held Okairos, a Swiss company. Okairos’ own vaccine platform technology works by delivering genetic material into cells to stimulate immune responses. Okairos has done work in hepatitis C and malaria so far but the company also aims to develop therapeutic cancer vaccines. That poses potential competition for Heat as the field of immunotherapy candidates grows.