About Us

Activating and Stimulating T-cells

Heat Biologics is a biopharmaceutical company that is developing immunotherapies to activate a patient's immune system against cancer. Our drugs are designed to take advantage of a natural biological process to robustly activate and stimulate T-cells to turn COLD Tumors HOT.

Breakthrough Therapies via a T-cell Activation Platform

Heat Biologics is an immuno-oncology company developing breakthrough therapies based on our T-cell Activation Platform (TCAP) designed to activate “killer” T-cells, to destroy a patient’s cancer. By turning " COLD tumors HOT," Heat’s drug candidates are designed to become an essential ingredient of the immuno-oncology cocktail to enhance the effectiveness of checkpoint inhibitors and other cancer therapies.

The "secret sauce" of our approach is its capability to unleash a broad swath of tumor antigens to the immune system and prime T-cell recognition of these antigens. Our approach enables broad antigen targeting of known and unknown tumor associated antigens complexed with gp96, the most powerful, naturally occurring immune adjuvant. Our drug candidates prime immune recognition and triggers the immune system to seek and destroy the cancer cells. Our therapies are designed to enhance the efficacy of checkpoint inhibitors and other immunotherapies and improve outcomes for those patients least likely to respond to checkpoint inhibitors alone.

“Off-the-Shelf” Drugs that are Fully Scalable

Our "off-the-shelf" drugs are produced to scale and require no patient-specific manufacturing. They are produced from allogeneic cancer cell lines that are genetically engineered to secrete common tumor antigens to prime T-cell recognition and activation.

Clinical Trials

We are currently enrolling patients in our Phase 2 clinical trial for non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo®) and plan on launching additional clinical trials utilizing our novel ComPACT and co-stimulatory antibodies within the coming months.

For additional information on our lung cancer trial, please visit clinicaltrials.gov

Harnessing the Immune System to Turn Cold Tumors Hot

We seek to enhance the response rate to checkpoint inhibitors through a combination treatment that activates the immune defense mechanisms to seek out and kill cancer cells.

Enhancing Immune Response Through T-cell Activation

Enhancing Immune Response Through T-cell Activation

Our T-cell Activation Platform (“TCAP”) produces therapies that are administered with checkpoint inhibitors and other immuno-modulators to enhance immune response through T-cell activation.

Genetically engineered allogenic cells are injected into the patient to elicit an immune response against a targeted tumor. The treatment primes immune recognition and triggers the body to stimulate the immune system to seek and destroy the cancer cells.

Turning Immunologically “Cold” Tumors “Hot”

Turning Immunologically “Cold” Tumors “Hot”

Our TCAP produces allogeneic, off-the-shelf therapies designed to activate the immune system to turn immunologically "cold" tumors "hot".

Our ImPACT therapies are designed to be administered alongside checkpoint inhibitors and other immuno-modulators to increase effectiveness.

Our ComPACT therapy combines T-cell activators and co-stimulators within a single treatment, simplifying combination immunotherapy while offering the potential for superior immune activation and reduced treatment costs.

Heat’s Therapeutic Advantages versus Autologous Personalized Therapies

Heat’s “one-size-fits-all” TCAP approach offers many advantages to autologous or personalized therapies

Heat Biologics TCAP Therapies
Autologous “Personalized” Approaches
Type of Therapy
Allogeneic “Off-the-Shelf”

Custom manufacturing is not necessary, resulting in a much lower cost of good sold than autologous therapies.

Autologous “personalized”

Harvest cancer or cells through leukopheresis, reprogramming and reinfusing them back into patient

Personalized, autologous treatment approaches often require surgery to remove a tumor sample in order to isolate a patient’s T-cells, genetically modify them and inject them back into the patient. In the case of CAR-T therapy, the method requires harvesting a patient’s white blood cells to be reprogrammed and then reinfused back into the patient.

Treatment Delay
Begin Patient Treatment Immediately

Our products are off-the-shelf and ready to use. Patients may begin treatment immediately without having to wait many weeks or months for personalized processing.

Long Procedure Times

These methods can take a month or longer to complete before the drug product can be injected into the patient.

Patient Convenience
Very Convenient

Absolutely nothing extracted from patient. Simple intradermal injection takes about 2 minutes.

Inconvenient

Patient cells must be harvested through apheresis. Infusion of finished product into patient. Often requires post-treatment monitoring in ICU for up to two weeks.

Costs
Low Cost of Goods

Fully scalable production enables us to price our TCAP products competitively.

High Cost of Goods

Our TCAP therapies have been shown to stimulate an immune response against the full antigenic repertoire of cancer cells, not just one or a handful of antigens. They are designed to combine broad antigen targeting of known and unknown tumor-associated antigens complexed with a potent immune adjuvant. The activated immune response generated by our TCAP therapies may be useful in treating a wide range of cancers and infectious diseases.

Our approach is designed to deliver effective immune activation at a much lower cost of goods sold than autologous or personalized therapies. The high cost of these personalized treatments is highlighted in the Wall Street Journal graphic below.

"The Million Dollar Cancer Treatment, Who Will Pay" The Wall Street Journal August 14, 2018