HCWB HCW Biologics Inc

HCW Biologics Inc. (“HCW Biologics” or the “Company”) (NASDAQ: HCWB), 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, was granted U.S. Patent No. 11,672,826 on June 13, 2023, which contains methods of use claims directed to administering the Company’s clinical-stage bifunctional immunotherapeutic, HCW9218, to treat cancer, including colorectal cancer, breast cancer, ovarian cancer, hepatocellular carcinoma, gastric cancer, urothelial carcinoma, and melanoma. The patent also includes methods of use claims for killing or reducing the number of senescent cells by administering HCW9218 in subjects with cancer. Senescence is considered a physiologic process that is important in promoting wound healing, regeneration, and many other vital functions. However, stressors cause accumulation of senescent cells which modifies the microenvironment in tissues and organs and creates chronic, sterile inflammation, which drives aging and age-related diseases. This patent further strengthens the Company’s position as a leader in the emerging field of inflammaging.

Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “This patent supports our commitment to treat diseases driven by chronic inflammation typical of aging and age-related diseases, including cancer. These diseases are promoted by cellular senescence and the proinflammatory factors they secrete, known as SASP factors.” He continued, “We believe that HCW9218 has the potential to redefine the approach for treating aging conditions and age-related diseases by alleviating senescence with an immunotherapeutic therapy that rejuvenates the immune system. Aged immune systems can often breakdown and stop operating the way they were intended, and this opens the door to many age-related pathologies.”

In addition to U.S. Patent No. 11,672,826, on March 26, 2023, the Company published a pivotal scientific paper in Aging Cell entitled, “Immunotherapeutic approach to reduce senescent cells and alleviate senescence-associated secretary phenotype in mice.” Dr. Wong explained, “The publication of our scientific paper in Aging Cell followed by the issuance of this patent for methods of treating age-related disorders is noteworthy. These events acknowledge that we may have found a novel method for the treatment of cancer and other age-related disorders.”

HCW9218 is currently being evaluated in two initial-stage clinical trials with the primary objectives to determine safety, maximum tolerated dose, and the recommended Phase 2 dose. The ongoing studies are an investigator-sponsored Phase 1 clinical trial to evaluate HCW9218 in the treatment of advanced solid tumors at the Masonic Cancer Center, University of Minnesota, and a Company-sponsored multicenter Phase 1b clinical trial to evaluate HCW9218 in advanced pancreatic cancer. There have been no dose-limiting toxicities reported in either trial to date. The Company believes the Phase 1/1b studies will be completed in 2023.

HCW Biologics is represented by a leading global intellectual property law firm, Fish & Richardson P.C. Tiffany A. Reiter, PhD., Principal in the Boston office of Fish & Richardson, stated, “We are pleased that our client, HCW Biologics, has met another milestone in its intellectual property development. The U.S. Patent and Trademark Office recognized the methods of treating cancer using the novel immunotherapeutic, HCW9218. This method of use patent will support a previously issued patent, U.S. Patent No. 11,518,792, which specifically provides intellectual property protection for the Company’s lead drug candidate, HCW9218.”

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, autoimmune diseases, as well as other conditions such as long-haul COVID-19. The Company has combined a 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 TOBITM 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 potential of HCW9218 to redefine the approach to treating aging conditions and age-related diseases; that HCW9218 may be used to treat cancer and is able to kill or reduce the number of senescent cells; and the completion of Phase 1/1b clinical studies in 2023. 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 (“SEC”) on May 9, 2023, and the annual report on Form 10-K filed with the SEC on March 28, 2023, 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. 

Company Contact:Rebecca ByamCFOHCW Biologics Inc.rebeccabyam@hcwbiologics.com