Advanced Non-Small Cell Lung Cancer (“NSCLC”)
HS-110 utilizes ImPACT-modified lung cancer cells to stimulate a patient’s immune system to activate a cytotoxic T cell response against a range of antigens that are known to be expressed by a high proportion of patients with NSCLC. The backbone cell line for HS-110 was selected based on antigenic overlap with patient tumor specimens, including known antigens as well as many additional known and unknown antigens. This approach provides a significant advantage over single antigen approaches by reducing the risk of antigen-loss variants emerging post-treatment and by addressing the underlying genetic and antigenic heterogeneity within tumors.
Heat Biologics is conducting two clinical trials evaluating HS-110 for the treatment of NSCLC:
- A multi-arm Phase 1b trial using HS-110 in combination with a PD-1 checkpoint inhibitor. For more information reference study protocol NCT02439450 on clinicaltrials.gov.
- A Phase 2 randomized, controlled trial using HS-110 in combination with cyclophosphamide. For more information reference study protocol NCT02117024 on clinicaltrials.gov.
Phase 1b HS-110 + PD-1 Checkpoint Inhibitor Combination Trial Design
Phase 2 HS-110 + Cyclophosphamide (CY) Combination Trial Design
- Low-dose cyclophosphamide (CY) 50 mg daily for 7 days every 2 weeks for 12 weeks or until progression
- HS-110 107 cells weekly for 12 weeks then every 9 weeks until irPD or 12 months, whichever comes first
About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer-related deaths in the U.S. According to the National Cancer Institute, each year over 220,000 people will be diagnosed with lung cancer in the United States alone and over 70% of these people will die from their disease. The treatment plan for patients diagnosed with lung cancer depends upon the stage of the disease.
There have been some advances in late stage lung cancer treatment options in the last several years but NSCLC remains the most common of all lethal cancers. Heat's allogeneic, off-the-shelf HS-110 vaccine therapy has the potential to improve the lung cancer treatment landscape and address an unmet need by offering patients access to investigational agents in the 3rd-line setting where there are currently very few approved options.