On July 23, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics"), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat diseases promoted by chronic inflammation, focusing on autoimmune disorders and other inflammatory diseases, cancer and senescence-associated dysplasia, reported that it has requested a Type B (pre-IND application) meeting with the U.S. FDA to discuss the development and regulatory strategy for its investigational lead product candidate, HCW11-018b, a tetravalent T-cell engager ("TCE") constructed with the Company’s proprietary TRBC drug development platform.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
HCW11-018b is intended to treat solid tumors and is administered by subcutaneous injection. In preclinical studies, it has shown the ability to target tissue factor-expressing cancer cells and activate CD3-positive effector T cells, while simultaneously reducing immunosuppression in the tumor microenvironment. Immunosuppression in the tumor microenvironment can limit effector T-cell infiltration and antitumor activity in solid tumors, particularly in gynecologic and pancreatic cancers.
TCEs have emerged as a potent therapeutic modality to treat cancer. First-generation TCEs represented a breakthrough in immunotherapy but they continue to face significant challenges, including antigen selection, limited efficacy in solid tumors, tolerability and safety concerns, and require a complex manufacturing process. Extensive preclinical studies of HCW11-018b –including assessments of in vitro and in vivo potency, antigen specificity, pharmacokinetics, toxicity in nonhuman primates, and its therapeutic window — suggest that it may be able to overcome the limitations of earlier-generation TCEs.
Currently, the U.S. FDA and other regulatory agencies have approved eight TCEs to be used to treat 12 indications. Even with a very limited number of approved indications, approved TCEs generate multi-billion-dollar annual sales. The level of interest for this area from major pharmaceutical companies remains strong over many years, as indicated by the large number of high-value partnerships formed with innovative biotechnology companies developing second-generation TCEs. These partnerships have likely been driven by TCE’s potential in both oncology and autoimmune diseases.
Dr. Hing C. Wong, the Company’s Founder and CEO, stated, "We are pleased to have reached this important milestone in the development of HCW11-018b and look forward to discussing our proposed clinical trial designs, nonclinical testing programs, and CMC data with the FDA. HCW11-018b exhibits remarkable anti-tumor activities with high tolerability in animal models. We discovered that it can penetrate into the tumor microenvironment with potent and antigen-specific anti-pancreatic cancer activities."
Dr. Wong continued, "We believe we have established a robust, streamlined, and cost-efficient manufacturing process capable of producing high-quality cGMP material to support HCW11-018b in clinical development and potential future commercialization. Our manufacturing process is based on high-producing recombinant CHO cell lines and a proprietary monoclonal antibody needed for the affinity purification process. The monoclonal antibody is currently being manufactured under GMP standards using a top-tier CDMO."
About HCW11-018b:
HCW11-108b is designed to treat a wide spectrum of solid tumors with enhanced anti-tumor activities and tolerability. HCW Biologics has identified HCW11-018b as the lead candidate in its Tetravalent T-Cell Engager Program, known as the "Big BiTE." The unique structure of the Big BiTE combines a tumor-associated tissue factor-targeting BiTE with IL-15 immune stimulation, in addition to a TGF-β trap to address immunosuppression in the tumor microenvironment. HCW11-018b was created using the Company’s proprietary TRBC drug development platform, without using the Fc fusion technology commonly found in bi-specific or tri-specific fusion molecules. In extensive preclinical studies, HCW11-018b demonstrated that it induces robust, sustained, antigen-specific tumor killing, enhances CD8⁺ T-cell activation, survival, and effector functions and promotes tumor infiltration into solid tumors. Further, HCW11-018b demonstrated in preclinical studies that it does not trigger cytokine release syndrome, a major concern of using BiTEs, when used in its therapeutic dose range.
(Press release, HCW Biologics, JUL 23, 2026, View Source [SID1234669410])