HCW Biologics Enters CRADA with National Cancer Institute

NCI Activated as Clinical Site for Phase 1b/2 Clinical Trial to Evaluate HCW9218 in Advanced Pancreatic Cancer

MIRAMAR, Fla., Dec. 08, 2022 (GLOBE NEWSWIRE) — HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage 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 under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and HCW Biologics Inc. (HCW Biologics) will collaborate to perform a Phase 1b/2 clinical study to evaluate the safety and tolerability of HCW Biologics’ proprietary agent, HCW9218, in patients with advanced/metastatic pancreatic cancer. The CRADA is entitled, “A Phase 1b/2 Study of HCW9218, a Bifunctional TGF- β Antagonist/IL-15 Protein Complex, for Advanced Pancreatic Cancer.” The Principal Investigator at NCI is Christine Alewine, M.D., Ph.D. Dr. Alewine is a Lasker Clinical Research Scholar at the National Institutes of Health in the Laboratory of Molecular Biology. Her research focuses on identifying new treatments for pancreatic cancer including pancreatic adenocarcinoma, adenosquamous carcinoma, and acinar cell carcinoma. Dr. Alewine is board certified in internal medicine and medical oncology.

About the Center for Cancer Research at the National Cancer Institute:
The Center for Cancer Research (CCR), NCI’s specialized internal cancer center, has a robust clinical research program, the largest at the National Institutes of Health. Their physician‐scientists conduct clinical trials that explore unique and understudied questions in cancer research and treatment. CCR collaborates extensively with partners in industry, non‐governmental organizations and academia to conduct clinical trials. As a federally funded entity, a fundamental goal is for CCR to publicize its research activities to the general public.

About the Phase 1b/2 Clinical Trial to Evaluate HCW9218 in Advanced Pancreatic Cancer
See, “HCW9218 for Advanced Pancreatic Cancer,” at Clinicaltrials.gov Identifier: NCT05304936.

About Advanced Pancreatic Cancer:
Pancreatic cancer is the third leading cause of cancer death in the United States. The disease accounts for approximately 3% of all cancers. This disease is most frequently diagnosed among people aged 65–74. In 2022, there will be an estimated 62,210 new cases of pancreatic cancer and 49,830 deaths in the U.S. Incidence rates of pancreatic cancer have gone up by around 1% each year since 2000. Worldwide, an estimated 495,773 people were diagnosed with pancreatic cancer in 2020. Because survival is poor, the population distribution of people who die of pancreatic cancer is similar to that of people who are diagnosed with the disease. In part because it is difficult to detect early, the average survival time from pancreatic cancer is low.

About HCW Biologics:

HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, and autoimmune diseases. The Company has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ (Tissue factOr-Based fusIon) discovery platform. The Company uses its TOBI^TM discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The invention of HCW Biologics’ two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The Masonic Cancer Center, University of Minnesota, has initiated a Phase 1 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant solid tumors that have progressed after prior chemotherapies (Clinicaltrials.gov: NCT05322408). The Company is also enrolling patients in a Company-sponsored Phase 1b/2 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant advanced pancreatic cancer (Clinicaltrials.gov: NCT05304936). The Company’s lead molecule for its regulatory T cell expansion program, HCW9302, is currently undergoing IND-enabling studies for an autoimmune indication.

Forward Looking Statements:
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, without limitation, statements regarding HCW9218 being a new category of cancer treatment capable of modifying factors related to drug resistance and disease recurrence; the ability of HCW9218 to treat cancer; and the ability of HCW9218 to neutralize TGF-β and the Company’s ability to provide an early human data readout. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on November 7, 2022 and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.