HCWB stock exploded more than 80% higher in early trading on October 28, 2021, after announcing FDA clearance to proceed with its pancreatic cancer study trial.

HCW Biologics Receives FDA Clearance to Proceed with Phase 1b Clinical Trial for Immunotherapeutic HCW9218 for Pancreatic Cancer

October 28, 2021, HCW Biologics Inc. (the “Company”) (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan 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 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 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.”

Pancreatic cancer develops when anomalous cells 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 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. Pancreatic cancer also has no early symptoms. There are currently no effective screening tests, so the disease is often discovered after the disease has spread to other areas of the body.

HCW Biologics Announces Appointment of Two New Members to Board of Directors

On October 27, 2021, HCW Biologics Inc. announced the appointment of two new independent directors, Lisa M. Giles and Gary M. Winer, to its Board of Directors, effective immediately. The appointments expand the Company’s Board to five members, four of whom are independent directors.

“Adding individuals with Lisa’s and Gary’s extensive talents and corporate experience in the life sciences industry is an important achievement for our Company and stockholders that we believe will contribute greatly to our long-term success,” said Hing C. Wong, Ph.D., founder, and CEO of HCW Biologics. “Gary and Lisa have long, successful careers building life sciences businesses and serving in senior management roles. On behalf of the Board, I am pleased to welcome them to HCW Biologics and look forward to benefitting from their knowledge and expertise.”

Ms. Giles and Mr. Winer will serve on the Board’s audit committee, chaired by Rick S. Greene, and the Board’s compensation committee, chaired by Scott T. Garrett. Dr. Wong will step down from the audit committee but remain a member of the Board of Directors. Mr. Garrett will continue as Chairman of the Board of Directors.

Ms. Giles commented, “Under Dr. Wong’s leadership, HCW stands at the vanguard in the development of a new generation of immunotherapeutics that address the age-related disorders associated with chronic inflammation. The Company’s recent initial public offering and the expected advancement of its lead drug candidate, HCW9218, into clinical trials, are exciting opportunities for patients and HCW’s growth, one that could deliver significant stockholder value. I look forward to working with Dr. Wong, the leadership team, and the other Board members as HCW advances its clinical development portfolio.”

Mr. Winer commented, “I am eager to work with Dr. Wong and the other Board members to help HCW Biologics achieve its full potential. As the Company continues to advance the development of its lead drug candidates, HCW9218 and HCW9302, I expect stockholders and patients to have the opportunity to benefit from important therapeutic advancements that could change the treatment of age-related disorders. I look forward to providing guidance to the Company based on my experience working with multinational pharmaceutical companies if and when the Company is ready to strike strategic collaborations and co-development deals.”

HCWB Stock Technical Analysis

Large players’ volume has exploded higher, but the technical rating of HCWB is bad, and it also does not present a quality setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation. Click here to sign up for email alerts when HCWB stock is a good entry.

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