HCW Biologics in Strong Momentum After FDA Clearance to Proceed with Phase 1b Clinical Trial for Potential Pancreatic Cancer Treatment

Oct 28, 2021 By MarketDepth

Biotechnology Headlines Healthcare What's Hot

Cancer Research

HCW Biologics Inc. (NASDAQ: HCWB) shares jumped more than 65% on Thursday after the biopharmaceutical Company announced that it has received clearance from the 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. 

Phase II Trials

HCW Biologics focuses on discovering and developing novel immunotherapies for chronic, low-grade inflammation, and age-related diseases. The company’s lead product include HCW9218, which is an injectable immunotherapeutic for patients with pancreatic, ovarian, breast, prostate, and colorectal cancers, as well as pulmonary fibrosis; and HCW9302 for auto-immune diseases, such as alopecia areata and metabolic diseases. It also develops HCW9201, a cell-based therapy that is in Phase II clinical trials for the treatment of patients with relapsed/refractory acute myeloid leukemia; and HCW9206 for the treatment of acute myeloid leukemia. 

“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.”

Hing C. Wong, Ph.D., Founder and CEO of HCW Biologics

According to the American Cancer Society, it is estimated 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 disease, making it the third leading cause of cancer-related death behind lung and colon cancers. Most pancreatic cancer patients are diagnosed at stage IV. Because the pancreas lies deep in the abdomen, a physical examination would not detect the presence of a pancreatic tumor.