HCW Biologics Maintains Momentum Toward Completion of IND Application for Clinical Study to Evaluate Lead T-Cell Engager in Solid Tumors
Globe Newswire•09/10/2026•09:00 ET
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Key Highlights
- ➤FDA Type B meeting provided guidance for HCW11-018b IND preparation
- ➤IND application remains on track for filing in 1H 2027
- ➤cGMP manufacturing of clinical-trial material is underway
- ➤HCW11-018b is HCW Biologics’ lead second-generation T-Cell Engager candidate
Expert Statements
Hing C. Wong, Founder and Chief Executive Officer of HCW Biologics
“Tissue factor has been shown to be highly expressed by various solid tumors. Cancers that hijack the body’s TF are very difficult-to-treat cancers. They use TF to avoid immune-cells that would attack them, use extracellular matrix interactions to promote the growth of cancer, increase chances for metastasis, and build resistance to standard-of-care therapies.”
Hing C. Wong, Founder and Chief Executive Officer of HCW Biologics
“With our non-Fc based T-Cell Engager program derived from the TRBC platform technology, we have created a second-generation T-Cell Engager, HCW11-018b. HCW11-018b has demonstrated that the addition of TGFβ-trap and IL-15 components onto a BiTE domain can overcome the deficiencies of BiTE alone for solid tumor therapy. We are pleased with the clear regulatory guidance provided by the FDA at our recent Type B meeting regarding the preparation of an IND application for a first-in-human clinical study of HCW11-018b in cancer. This guidance enables us to maintain our momentum toward achieving our target to file the IND application in the 1H 2027.”
Communication with FDA at recent Type B meeting provided clear guidance for next steps to prepare IND application to support first-in-human clinical study in cancer
HCW11-018b is Company’s lead candidate in its second-generation T-Cell Engager Program constructed using proprietary non-FC based TRBC platform technology
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