On August 25, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on developing novel fusion immunotherapeutics to treat autoimmune diseases, cancer, and senescence-associated dysplasia, together with collaborators at leading research institutions, reported to have identified a TGF-β trap and IL-15 fusion as a novel moiety with potential applications against diseased cells and viral infections. Human studies showed that the TGF-β trap and IL-15 fusion promoted expansion of progenitor CD8+ T cells and Natural Killer ("NK") cells, provided clinical benefit, and was well tolerated in cancer patients. In addition, the fusion demonstrated activity against HIV-1 and bronchopulmonary dysplasia in highly stringent, relevant animal models. Several publications in leading scientific journals include extensive human and animal study data regarding the TGF-β trap and IL-15 fusion (see References below).
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The Company has incorporated these ground-breaking discoveries into its second-generation T Cell Engager ("TCE") and Immune Checkpoint Inhibitor ("ICI") programs, created with its TRBC drug development platform, to strengthen anti-tumor activity and help address the effects of senescent cell accumulation. Its lead product candidate in the TCE Program, HCW11-018b, combines a TGF-β trap and IL-15 fusion with a tissue-factor-targeting BiTE (Bispecific T-cell Engager). This design provides IL-15-driven immune stimulation while using the TGF-β trap to counter immunosuppression and poor T-cell infiltration in solid tumors. HCW11-040, lead candidate of the Company’s second-generation ICI program, is a unique combination of pembrolizumab, a generic form of Keytruda, and the added-on TGF-β/IL-15 moiety, which has demonstrated superior immune-cell activation, expansion, tumor infiltration, and cytotoxicity against cancer cells and tumors compared with pembrolizumab in in-vitro and in-vivo preclinical studies. Both molecules are at IND-enabling stage, and the Company plans to initiate clinical studies in 2027.
Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, "HCW Biologics is the leader in creation of multi-valent immunotherapeutics with a unique protein-based scaffold, without the antibody Fc domain. By leveraging our ground-breaking discovery of the novel properties of the TGF-β/IL-15 fusion moiety and incorporating it into our second-generation fusion molecules, we have demonstrated enhanced therapeutic activity over traditional immune checkpoint inhibitor- and BiTE-based approaches. We believe our novel multi-valent immunotherapeutics could revolutionize the immunotherapy field, especially against cancers and senescence-associated dysplasia."
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. and the company is not affiliated with HCWB.
(Press release, HCW Biologics, AUG 25, 2026, View Source [SID1234670335])