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HCW Biologics Receives FDA Clearance to Proceed with Phase 1b Clinical Trial for Immunotherapeutic HCW9218 for Pancreatic Cancer
Company cleared to proceed with first-in-human clinical trial to evaluate HCW9218, Company’s lead product candidate, in refractory, advanced/metastatic
About this update from Hcw Biologics Inc.
[{"type":"text","content":"Company cleared to proceed with first-in-human clinical trial to evaluate HCW9218, Company’s lead product candidate, in refractory, advanced/metastatic pancreatic cancer MIRAMAR, Fla., Oct. 28, 2021 (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 it has been cleared by the U.S. Food and Drug Administration (FDA) to proceed to evaluate its lead drug candidate, HCW9218, in a first-in-human Phase 1b clinical trial in patients with advanced pancreatic cancer. HCW9218 is an injectable, fusion protein complex designed to drive bifunctional, anti-tumor activity by activating desired immune responses to attack cancer cells while simultaneously blocking unwanted immunosuppressive activities. Hing C. Wong, Ph.D., Founder and CEO of HCW Biologics, stated, \"The FDA’s clearance to proceed with our first-in-human trial for HCW9218 in pancreatic cancer is an important milestone for HCW Biologics and our efforts to advance the development of potentially groundbreaking immunotherapy candidates for cancer and other age-related diseases. Advances in immuno-stimulatory and anti-immunosuppressive therapeutics have revolutionized cancer treatment. We have created a bifunctional heterodimeric molecule, HCW9218, that can both stimulate the immune system and block the immunosuppressive activity of transforming growth factor-β. In preclinical studies, we showed that HCW9218 enhanced the anti-tumor efficacy of chemotherapy docetaxel and gemcitabine plus nab-paclitaxel against melanoma and pancreatic cancer, respectively, and simultaneously alleviated the off-target, unwanted effects of chemotherapies on normal tissues. In experimental animal models, HCW9218 was also shown to augment anti-tumor activities of therapeutic and checkpoint antibodies, which are currently standard-of-care anti-cancer treatment for certain solid tumors.” About Pancreatic Cancer:Pancreatic cancer develops when anomalous cells in the pancreas grow and divide out of control to form a tumor. The American Cancer Society estimates that this year in the U.S. alone, there will be 60,430 new pancreatic cancer cases diagnosed, and 48,220 people will die from the dise...