Phase I of first-in-human clinical trial of bifunctional immunotherapeutic for advanced solid tumor cancers

Physicians and scientists at the University of Minnesota have opened a new solid tumor cancer clinical trial and have treated their first patient with HCW9218, an injectable, bifunctional immunotherapeutic, developed by HCW Biologics Inc (NASDAQ: HCWB). This Phase I, first-in-human clinical trial is enrolling patients that have advanced solid tumors with progressive disease after prior chemotherapies.

The trial is led by U of M oncologist Melissa Geller, MD, MS, a professor and division director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women's Health (OBGYN) in the Medical School and the Masonic Cancer Center's associate director for Clinical Research, with collaboration from Jeffrey Miller, MD, a professor of medicine in the Medical School's Division of Hematology, Oncology and Transplantation and deputy director of the Masonic Cancer Center, and Manish Patel, DO, an associate professor of medicine in the Division of Hematology, Oncology and Transplantation and director of the Developmental Therapeutics Clinic.

"Our team is very excited to bring this clinical trial to patients who have recurrent cancer," noted Geller. "With the ease of a subcutaneous injection, this innovative compound can stimulate the immune system while at the same time inhibiting proteins that cause immunosuppression. This unique combination will provide patients with cancer a novel immune-based therapy when previous treatments have failed."

The treatment, HCW9218, has an IL-15 component that activates the immune system (NK cells and T cells) and a second component that neutralizes TGF-beta, a common protein induced by tumors to suppress the immune system. As a result, this bifunctional fusion protein complex is designed to drive anti-tumor immune activity to attack cancer cells while simultaneously blocking unwanted immunosuppressive activities.