HS-110 for the Treatment of Non-small Cell Lung Cancer

HS-110 (viagenpumatucel-L)

HS-110 is our first biologic product candidate in a series of proprietary ImPACT® based immunotherapies designed to stimulate a patient’s own T-cells to attack cancer.

Using our ImPACT platform technology, Heat developed HS-110 as a potential treatment for patients with non-small cell lung cancer. HS-110 is made of a cancer cell line that has been genetically modified using our ImPACT technology platform. It is designed to secrete a wide range of lung cancer-associated antigens bound to gp96 proteins, while activating a broad, T-cell mediated immune response against the patient’s cancer.

About Non-small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer-related deaths in the U.S. According to the National Cancer Institute, more than 220,000 people each year are diagnosed with lung cancer in the U.S. and over 70% of these patients will die from their disease. The treatment plan for patients diagnosed with lung cancer depends upon the stage of the disease.

There have been recent advances in late-stage lung cancer treatment, but NSCLC remains the most common of all lethal cancers. Heat’s allogeneic, off-the-shelf HS-110 therapy has the potential to improve the lung cancer treatment landscape, and address an unmet need by offering patients access to investigational medicines in the third-line setting in which there are currently very few approved options.

HS-110 Phase 2 Clinical Trial (DURGA)

Our HS-110 Phase 2, multicenter clinical trial is evaluating the safety and efficacy of HS-110 in combination with Bristol-Myers Squibb’s checkpoint inhibitor, nivolumab (Opdivo®), in patients with NSCLC whose cancers have progressed after first-line therapy. Positive interim results for the first 15 patients enrolled suggest HS-110 plays an integral role in tumor reduction and may enhance efficacy of checkpoint inhibitors in lung cancer patients.

Visit www.clinicaltrials.gov for more details.

Phase 2 HS-110 + an anti-PD-1 Checkpoint Inhibitor Combination Trial Design

HS-110 Product Manufacturing

The HS-110 product used in our clinical trials is manufactured under cGMP (current good manufacturing practices). The cell line is grown in large quantities, dispensed into individual doses, frozen in liquid nitrogen, irradiated to render cell replication incompetent and quality tested in compliance with FDA guidelines.