MIRAMAR, Fla. — October 9, 2026
HCW Biologics Inc. announced continued progress toward an Investigational New Drug (IND) application for HCW11-018b, its lead candidate in a second-generation T-cell engager program targeting solid tumors. Following a recent FDA Type B meeting, the company reported receiving regulatory guidance on the next steps for preparing the application. Manufacturing of current Good Manufacturing Practice (cGMP) material for clinical trials is underway, and HCW Biologics continues to target an IND filing in the first half of 2027 to support a planned first-in-human clinical study.
Second-Generation T-Cell Engager Targets Solid Tumors
HCW11-018b is being developed using HCW Biologics’ proprietary TRBC platform technology, which employs a protein-based scaffold to construct tetravalent molecules without an antibody Fc domain. The candidate combines features of a bispecific T-cell engager (BiTE) with additional components designed to address the immunosuppressive tumor microenvironment. Its BiTE component includes an anti-CD3 single-chain antibody and a domain targeting tissue factor (TF), a protein expressed at elevated levels in a range of solid tumors. The approach is intended to direct T cells toward TF-positive tumor cells while incorporating additional immune-modulating mechanisms.
IL-15 and TGF-β Trap Designed to Support Immune Activity
The candidate incorporates soluble interleukin-15 (IL-15), an IL-15 receptor alpha (IL-15Rα) domain, and a transforming growth factor beta receptor II (TGFβRII) domain trap. According to the company, the IL-15/IL-15Rα components are designed to support the survival, proliferation, and cytotoxic activity of CD8-positive T cells and natural killer (NK) cells. The TGFβRII domain is intended to bind TGF-β, a signaling pathway associated with immune suppression and reduced infiltration of cancer-fighting cells into tumors. HCW Biologics stated that HCW11-018b has demonstrated potential benefits from combining these components with a BiTE domain; further clinical evaluation will be needed to establish its safety and efficacy in humans.
Advertisement
FDA Guidance Supports Planned Clinical Development
HCW Biologics said discussions at its recent FDA Type B meeting provided guidance for preparing the IND application and advancing the program toward its planned first-in-human study. The company is continuing manufacturing activities for clinical-grade material as it works toward the first-half 2027 filing target. HCW11-018b remains an investigational candidate and has not been established as a safe or effective treatment for solid tumors. The program represents part of HCW Biologics’ broader strategy to develop multivalent fusion immunotherapeutics for diseases associated with chronic inflammation, including cancer, autoimmune diseases, and senescence-associated dysplasia.
Source:: HCW Biologics press release
