Preclinical Data Show HCW Biologics’ TCEs Effective Against Pancreatic Cancer And Glioblastoma

HCW Biologics Inc., a U.S.-based clinical-stage biopharmaceutical company focused on developing novel immunotherapies for age-related diseases and cancer, announced the successful development of second-generation, tissue factor-targeting T-cell engagers (TCEs) for solid tumours, with a particular focus on pancreatic cancer and glioblastoma. These candidates were created using the company’s proprietary TRBC product discovery and development platform technology.

Dr. Hing C. Wong, the Company’s Founder and CEO, stated, “We are pleased to report that our proprietary TRBC platform was used to create second-generation T-cell engagers that we believe are effective, well-tolerated, and cost-effective that target difficult-to-treat solid tumors while managing tumor mediated immunosuppression. We have constructed a strong immunotherapeutic portfolio consisting of T-cell engagers with other antigen specificities using our proprietary TRBC technology.”

He continued, “Our preclinical studies show that our lead second-generation TCE could remarkably shrink the well-established tumors in mice models, and there was 100% survival among tumor-bearing mice treated with our TRBC-based TCE product candidate, whereas none of the untreated mice survived. We believe our approach could expand the number of indications that can be treated with our second-generation TCEs, such as autoimmune diseases and quality-of-life conditions, in addition to enhancing the healthspan for patients suffering with a wide spectrum of solid tumors, especially pancreatic cancer and glioblastoma.”

Dr. Wong concluded, “Since the development of a TCE is complex and requires a substantial amount of capital, our strategy is to develop our lead product candidate in partnership with a financially strong corporate partner. I am very excited that we have achieved major milestones for evaluating this anti-tissue factor T-cell engager’s preclinical safety profile and its ability to target solid tumors while managing tumor mediated immunosuppression. These findings provide the necessary data to initiate discussions with major players who may be interested in building their T-cell engager portfolio with our lead TCE and other second-generation TCE product candidates in our portfolio.”

While T-cell engagers (TCEs) have revolutionized cancer treatment since the 2014 FDA approval of Amgen’s BLINCYTO®, first-generation TCEs face key challenges, including antigen selection, poor efficacy in solid tumors, tolerability, safety concerns, and complex manufacturing. HCW Biologics’ second-generation approach aims to overcome these limitations. Preclinical studies demonstrated that its TCEs not only target tumor antigens and activate effector T cells via CD3, but also reduce immunosuppression within the tumor microenvironment, a critical barrier to effective therapy. Lead candidates targeting tissue factor and mesothelin have shown potent anti-pancreatic cancer activity in vitro and in humanized mouse models.

Importantly, in non-human primate safety studies, HCW Biologics’ subcutaneously administered anti-tissue factor TCE was well tolerated, even at higher-than-efficacious doses. No signs of overt toxicity or cytokine release syndrome (CRS)—a common and serious side effect of first-generation TCEs—were observed. Given that tissue factor is a validated cancer target (as seen with Pfizer’s TIVDAK® in cervical cancer) and is overexpressed in several aggressive cancers including glioblastoma, pancreatic, breast, and ovarian cancers, HCW Biologics sees broad potential for its TCE as a monotherapy or in combination with standard-of-care therapies. Furthermore, the company has developed a streamlined, cost-effective manufacturing process for its second-generation TRBC-based TCEs, supporting scalability for future development.