HCW Biologics Presents Preclinical Data for TRBC-Based T-Cell Engager Program at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting

Rhea-AI Summary

HCW Biologics (NASDAQ: HCWB) presented preclinical data for its tetra-valent, TRBC-based T‑Cell Engager (TCE) program at the SITC 40th Annual Meeting (Nov 5–9, 2025) in National Harbor, MD.

Key points: the lead candidate HCW11-018b showed tumor shrinkage in xenograft and PDX models, 100% survival in treated tumor-bearing mice versus 0% in untreated controls, activation of exhausted tumor‑infiltrating T cells, favorable tolerability and long serum half-life in non‑human primates, subcutaneous dosing, and a streamlined GMP manufacturing process without Fc fusion.

Insights

Translational Immunology Analyst

Preclinical data show promising TCE properties and NHP tolerability, but findings remain early and hypothesis‑generating.

HCW Biologics reports a tetra‑valent TRBC‑based T‑cell engager, HCW11‑018b, that produced tumor shrinkage in xenograft and PDX models and 100% survival in treated mice versus none in untreated controls; the program also showed favorable non‑human primate tolerability and extended serum half‑life without Fc fusion. These facts indicate the construct achieves core preclinical goals: target engagement, in vivo efficacy signals, manageable safety in NHPs, and manufacturability compatible with monoclonal antibody processes.

Key dependencies and limitations include that all efficacy data cited are preclinical, drawn from xenograft/PDX and NHP studies, and thus do not establish human safety or efficacy. The tolerability and pharmacokinetic findings in NHPs are supportive but not predictive of clinical outcomes; subcutaneous dosing and streamlined GMP are operational advantages only if reproduced at clinical scale.

Concrete items to watch: publication or peer review of the ePoster and underlying datasets after November 7, 2025, formal toxicology and GLP safety packages that enable an IND filing, and any announcement of a first‑in‑human study start date or clinical trial design. Expect near‑term informational updates (weeks–months) on poster materials and pre‑IND activities, with clinical milestones likely on a multi‑quarter to multi‑year horizon.

Tetra-valent T-cell engager designed to address shortfalls of bi-specific T-cell engagers (BiTE) related to manufacturability, safety profile, and ability to treat a wide spectrum of solid tumors 

MIRAMAR, Fla., Nov. 07, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and diseases, announced today the data presented for their tetra-valent, second-generation T-Cell Engager (“TCE”) Program based on their novel TRBC platform technology, at the SITC 40^th Annual Meeting, taking place from November 5 to 9, 2025 in National Harbor, Maryland.   

HCW Biologics debuted the results from its preclinical study of HCW11-018b, the Company’s lead T-cell engager product candidate, that highlights the uniqueness and advantages of its second-generation TCE program compared with the first-generation TCE products. Its unique features include:  

• Broad coverage for human solid tumor indications by targeting tissue factor, with high potency and precision, shown in xenograft models including the Patient-Derived Xenograft (PDX) tumor model.
• Tetra-valent construct to address immunosuppressive tumor microenvironment.
• Activates tumor-infiltrated exhausted T cells.
• Favorable tolerability profile in non-human primates at dosing levels significantly higher than the efficacious level.
• Long serum half-life and favorable pharmacokinetics shown in non-human primate studies, without using the Fc fusion technology commonly found in bi-specific or tri-specific fusion molecules.
• Streamlined GMP manufacturing process similar to the process used for therapeutic monoclonal antibodies.
• Subcutaneous administration to improve safety and quality-of-life for patients.
  

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “Remarkably, our preclinical studies showed that HCW11-018b, our lead second-generation TCE product candidate, could shrink the well-established tumors in xenograft animal models including the PDX model. There was 100% survival among tumor-bearing mice treated with HCW11-018b, whereas none of the untreated mice survived. In addition to enhancing the healthspan for patients suffering from a wide spectrum of solid tumors, especially pancreatic cancer and glioblastoma, we believe our approach could expand the number of indications that could possibly be treated with our tetra-valent, second-generation TCEs, such as autoimmune diseases and quality-of-life conditions.”

A poster, titled, “A novel multi-functional bispecific T-cell engager molecule for cancer therapy,” will be presented by Dr. Xiaoyun Zhu, the Company’s Senior Scientist, and Dr. Wong today at 12:15-1:45 pm, 5:35–7:00 pm ET, at Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center.

The ePoster will be available on the Company’s website in the Events and Presentations section after 9:00 am ET on November 7, 2025.

About HCW Biologics:

HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drugs that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and potentially extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as many indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is a versatile scaffold that enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics are being developed for treatment of a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform. Further preclinical evaluation studies are currently being conducted for these molecules the Company has selected based on promising preclinical data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules.

Forward Looking Statements:

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, the actual success and potency of the Company’s TCE-based TRBC fusion molecules; the ability of the Company’s TCE’s to target cancer antigens, activate effector T cells, and reduce immunosuppression in the tumor microenvironment; the ability of the Company’s TCEs to exhibit potent and antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models; effectiveness of the Company’s TCEs in treatment of solid tumors and pancreatic cancers. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2025, the latest Form 10-Q filed with the SEC on August 18, 2025 and in other filings filed from time to time with the SEC.  

Company Contact:

Dr. Peter Rhode
Chief Scientific Officer and Vice President of Clinical Operations
HCW Biologics Inc.
PeterRhode@HCWBiologics.com 

FAQ

What preclinical results did HCW Biologics (HCWB) report for HCW11-018b on November 7, 2025?

HCW11-018b produced tumor shrinkage in xenograft and PDX models and achieved 100% survival in treated tumor-bearing mice versus 0% in untreated mice.

When and where did HCW Biologics present the TRBC TCE data at SITC 2025?

HCW Biologics presented at the SITC 40th Annual Meeting in National Harbor, Maryland (Nov 5–9, 2025); the poster was presented on Nov 7, 2025 at Prince George ABC Exhibit Halls with sessions at 12:15–1:45 pm and 5:35–7:00 pm ET.

What tolerability and pharmacokinetic findings did HCWB disclose for HCW11-018b?

HCWB reported a favorable tolerability profile and long serum half-life in non‑human primates at dosing levels higher than the efficacious level.

How is HCW11-018b designed to improve on first‑generation T‑cell engagers?

HCW11-018b is a tetra‑valent, TRBC‑based TCE claimed to offer broad solid tumor coverage, improved manufacturability, activation of exhausted T cells, and subcutaneous dosing without Fc fusion.

Will HCW Biologics make the SITC ePoster for HCW11-018b available online and when?

Yes; the ePoster will be available on the company's website in the Events and Presentations section after 9:00 am ET on November 7, 2025.

Does HCW Biologics suggest clinical indications for the TRBC TCE program (HCWB)?

The company highlighted potential application across a wide spectrum of solid tumors, specifically mentioning pancreatic cancer and glioblastoma, and noted possible expansion to autoimmune and quality‑of‑life conditions.