Patient enrolment is expected to be initiated shortly in this trial, which allows the company to combine its HS-110 with multiple immune modulating strategies.
HS-110 is the company’s first product candidate in a series of proprietary ImPACT drugs designed to direct killer T cells to attack cancer.
Washington University Siteman Cancer Center associate professor of Medicine Daniel Morgensztern is the lead investigator of this new Phase Ib trial.
Dr Morgensztern noted: "Non-small cell lung cancer (NSCLC) is now recognized as a disease that appears susceptible to an immune therapy approach, based on the significant benefit reported with various checkpoint inhibitors."
Patients with NSCLC who have failed one or more prior lines of therapy will be enrolled in this multicenter Phase Ib trial, which is designed to evaluate the safety and efficacy of HS-110 in combination with multiple tumor anti-immunosuppressive agents.
The company said that immunosuppression may develop in NSCLC patients in a variety of ways, and this new trial is designed to explore use of combination approaches against multiple immunosuppression pathways.
Heat CEO Jeff Wolf said: "This Phase 1b design framework will allow us to efficiently test HS-110 with multiple combination agents enabling us to continue to deliver combinations at the forefront of immunotherapy.
"This single clinical protocol should enable us to efficiently evaluate many immunotherapy combinations to determine which combinations offer greatest benefit to patients with NSCLC."
Viagenpumatucel-L ImPACT-modified cell lines are designed 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 NSCLC patients.