Miramar, Fla. – August 25, 2026
HCW Biologics announced new findings supporting its TGF-β trap and IL-15 fusion moiety as a potential component of next-generation immunotherapeutics targeting cancer and other diseases. The company, together with research collaborators, reported that human studies of the fusion used alone showed expansion of progenitor CD8+ T cells and natural killer (NK) cells, while also demonstrating clinical benefit and tolerability in cancer patients. HCW Biologics has incorporated the TGF-β/IL-15 fusion into its second-generation fusion immunotherapeutic programs, using its proprietary TRBC drug development platform. The company is developing these programs to strengthen immune activity against diseased cells and address immunosuppressive mechanisms associated with solid tumors.
HCW Biologics Targets Tumor Immunosuppression
The company’s approach combines immune stimulation with suppression of tumor-driven immunosuppression. TGF-β can contribute to an immunosuppressive tumor microenvironment and limit effective immune-cell activity, while IL-15 can stimulate expansion and activity of immune cells. HCW Biologics has combined these functions into a single TGF-β trap/IL-15 fusion moiety, with the goal of enhancing immune responses against diseased cells. Human and preclinical studies cited by the company provide the scientific basis for incorporating the moiety into its next-generation therapeutic constructs. The company also reported activity in animal models involving HIV-1 and bronchopulmonary dysplasia, broadening the potential application of the technology beyond oncology.
HCW Biologics Builds Second-Generation Fusion Programs
The TGF-β/IL-15 technology has now been incorporated into HCW Biologics’ second-generation T-cell engager (TCE) and immune checkpoint inhibitor (ICI) programs. The lead TCE candidate, HCW11-018b, combines the TGF-β trap/IL-15 fusion with a tissue-factor-targeting BiTE designed to direct immune-cell activity toward target cells. According to the company, the construct is intended to provide IL-15-mediated immune stimulation while simultaneously countering TGF-β-associated immunosuppression and limited T-cell infiltration in solid tumors. The company is also advancing HCW11-040, its lead second-generation ICI candidate, which combines pembrolizumab with the additional TGF-β/IL-15 moiety. In preclinical testing, HCW Biologics reported greater immune-cell activation, expansion, tumor infiltration and cytotoxicity compared with pembrolizumab alone.
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HCW11-018b and HCW11-040 Move Toward Clinical Development
Both HCW11-018b and HCW11-040 remain at the IND-enabling stage, making preparation for human clinical development the company’s immediate development focus. HCW Biologics said it plans to initiate clinical studies in 2027. The company’s strategy centers on using its TRBC platform to create multi-valent fusion immunotherapeutics without the conventional antibody Fc domain. The newly highlighted TGF-β/IL-15 moiety is therefore being positioned as a key component of the company’s second-generation pipeline rather than as a standalone development program. The reported findings provide the scientific rationale for advancing these constructs toward IND submission and subsequent clinical evaluation in oncology.
Source:HCW Biologics press relese
