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Masonic Cancer Center at the University of Minnesota Receives FDA Clearance to Proceed with Phase 1 Clinical Trial in Solid Tumors for HCW9218, HCW Biologics’ Novel Bifunctional Fusion Protein
UM cleared to proceed with clinical trial to evaluate HCW9218 in various advanced solid tumors, such as breast, ovarian, prostate, and colorectal cancers
About this update from Hcw Biologics Inc.
[{"type":"text","content":"UM cleared to proceed with clinical trial to evaluate HCW9218 in various advanced solid tumors, such as breast, ovarian, prostate, and colorectal cancers\nMIRAMAR, Fla., Jan. 24, 2022 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company”) (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today announced that the Masonic Cancer Center, University of Minnesota was cleared by the U.S. Food and Drug Administration (FDA) to proceed to evaluate the Company’s lead drug candidate, HCW9218, in a Phase 1 clinical trial in patients with advanced solid tumors with progressive disease after prior chemotherapies. HCW9218 is an injectable, bifunctional fusion protein complex designed to drive anti-tumor activity by activating desired immune responses to attack cancer cells while simultaneously blocking unwanted immunosuppressive activities. The Principal Investigator of the clinical trial is Melissa A. Geller, M.D., M.S., Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota. Dr. Geller stated, “Because the immunosuppressive tumor microenvironment limits the success of current therapies, there is a critical need for novel immune based therapies for advanced solid tumors. The estimated percentages of patients who are eligible for and who respond to cancer treatments such as checkpoint inhibitor drugs remain modest. We are excited to be able to sponsor a clinical study for treatment-resistant solid tumors using HCW9218. This immunotherapeutic might be the answer we need to augment anti-tumor activities of existing standards of care chemotherapies.” “HCW9218 is a unique combination of a TGF-β receptor that neutralizes a highly immunosuppressive cytokine secreted by tumors, and IL-15, a potent cytokine that stimulates the natural killer and CD8+-T cell cytotoxicity. As a result, this bifunctional immunotherapeutic has the potential to drive significant anti-tumor activity,” noted Jeffrey A. Miller, M.D., Deputy Director of the Masonic Cancer Center, and Co-Principal Investigator for the study. “HCW9218 also may define a new category of cancer treatment through modifying factors related to drug resistance and...