HCW Biologics Inc. is a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation, and age-related diseases. The firm considers age-related low-grade chronic inflammation as a contributing factor to several chronic diseases and conditions, such as cancer, cardiovascular disease, diabetes, neurodegenerative diseases, and autoimmune diseases. The company was founded by Hing C. Wong on April 2, 2018 and is headquartered in Miramar, FL.
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2018
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- HCW Biologics entered an exclusive distribution agreement with Akron Biotech to commercialize HCW11-006, a multi-cytokine fusion molecule used as a reagent in CAR-T cell manufacturing. - HCW11-006 combines IL-7, IL-15, and IL-21 signals in a single molecule, and preclinical studies showed CAR-T cells made with it had stronger anti-tumor activity and enhanced antiviral potency. - The agreement includes pre-payment commitments for product sales and gives HCW Biologics a commercial route through Akron's network of research institutions and commercial customers. - HCW Biologics believes HCW11-006 could replace the αCD3/28/IL-2 industry-standard method and potentially lower CAR-T manufacturing costs, with clinical studies planned to confirm findings.
- HCW Biologics announced a positive preliminary human data readout from the first two dose cohorts of its Phase 1 trial of HCW9302, an IL-2-based fusion immunotherapeutic, in patients with alopecia areata. - All three participants in the second dose cohort (3 micrograms/kg) showed a ≥25% reduction in SALT scores at four and/or nine weeks after a single subcutaneous dose. - HCW9302 was well tolerated, with no dose-limiting toxicities, capillary leak, cytokine release syndrome, or increased blood eosinophil counts. - The Company projects establishing the recommended Phase 2 dose by year-end 2026, with a full Phase 1 readout expected in the fourth quarter of 2026.
- HCW Biologics presented preclinical data for HCW11-018b, a tetra-valent T-cell engager that demonstrated significant tumor shrinkage and metastasis prevention in xenograft animal models. - The therapy utilizes a novel cis-binding mechanism that activates only within the tumor microenvironment, potentially improving both efficacy and tolerability compared to existing approaches. - The company plans to file an IND application in the first half of 2027, with initial clinical focus on pancreatic and ovarian cancers. - HCW11-018b is part of the company's "Big BiTE" program based on TRBC platform technology, designed to treat a wide spectrum of solid tumors.
- Researchers at Albert Einstein College of Medicine have developed a new CAR-T cell manufacturing approach using a multi-cytokine fusion protein scaffold that dramatically extends the cells' therapeutic lifespan and effectiveness. - The innovative method generates CAR-T cells with over 50% T memory stem cells compared to less than 5% with conventional manufacturing, providing enhanced self-renewal capacity and sustained disease-fighting ability. - In mouse models, the new approach demonstrated superior performance against both blood cancers and HIV infection, with enhanced recall responses preventing tumor recurrence and more effective viral suppression. - The breakthrough could significantly reduce cancer relapse rates and advance HIV treatment toward a functional cure by maintaining long-term viral control after stopping antiretroviral therapy.
- HCW Biologics and WY Biotech have formed Beijing Trimmune Biotech, securing initial funding from CITIC Medical Fund and TigerMed to develop the cancer immunotherapy HCW11-006. - The joint venture involves a $7 million deal structure, with Trimmune holding exclusive worldwide licensing rights for HCW11-006 and planning Phase 1 trials in China for solid tumors by first half 2027. - HCW Biologics retains a royalty-free option to reclaim development rights for the Americas territory after Phase 1 completion, while receiving milestone payments and double-digit royalties on future sales.
- HCW Biologics has dosed the first patient in a Phase 1 clinical trial evaluating HCW9302, a novel interleukin-2 fusion molecule, for treating alopecia areata at The Ohio State University Wexner Medical Center. - The therapy targets regulatory T cells to control excessive inflammation that causes autoimmune hair loss, representing a first-in-kind approach for the 160 million people worldwide affected by alopecia areata. - The multi-center dose-escalation study will treat up to 30 patients to establish safety and determine the recommended Phase 2 dose, with potential expansion to other autoimmune conditions like vitiligo and atopic dermatitis. - HCW9302 demonstrated good tolerability in non-human primate studies and aims to address the lack of curative FDA-approved treatments for this condition that significantly impacts patients' quality of life.
- HCW Biologics has developed second-generation, multi-specific T-cell engagers using its proprietary TRBC platform technology that achieved 100% survival in tumor-bearing mice while untreated mice showed no survival. - The tetra-functional T-cell engagers target tissue factor and mesothelin antigens while simultaneously reducing immunosuppression in the tumor microenvironment, addressing a key challenge in solid tumor treatment. - The company's TRBC platform enables construction of immunotherapeutics that activate immune responses and target cancerous cells, with over 50 molecules constructed including lead candidates HCW11-002, HCW11-006, HCW11-018 and HCW11-027. - These T-cell engagers demonstrated potent and antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models at well-tolerated dose levels.
- HCW Biologics has successfully raised $5 million in a follow-on offering to fund clinical development of its novel immunotherapies targeting inflammation-related diseases, particularly its Phase 1 trial of HCW9302 for autoimmune disorders. - The company is advancing over 50 proprietary compounds developed through its TOBI and TRBC platforms, with plans to commercialize HCW9206, a promising reagent that could revolutionize CAR-T manufacturing by improving cell persistence and reducing costs. - Despite financial challenges, HCW Biologics is implementing a multi-step financing strategy while pursuing business development opportunities, including a potential $7 million licensing deal with WY Biotech for its HCW11-006 compound.
• HCW Biologics' proprietary fusion protein HCW9206 demonstrates superior efficacy in generating CAR-T cells with enhanced function and persistence compared to standard methods. • Studies presented at the 2025 American Association of Immunologists meeting show HCW9206 effectively expands stem cell-like memory T cells (Tscm), which exhibit greater persistence and targeted cell killing in experimental models. • The company has established GMP manufacturing processes and filed a drug master file with the FDA, positioning HCW9206 to potentially reduce costs and improve clinical outcomes for CAR-T therapies.
- HCW Biologics received FDA clearance for its IND application to begin a Phase 1 trial of HCW9302 in moderate-to-severe alopecia areata patients. - HCW9302 is a first-in-kind injectable IL-2 fusion protein complex designed to activate and expand regulatory T cells for autoimmune disease treatment. - The Phase 1 trial will focus on dose escalation to establish a safe and effective dose that increases Treg cell activity in alopecia areata patients. - HCW Biologics plans to expand clinical development of HCW9302 into Phase 2 studies for other autoimmune and inflammatory conditions after Phase 1.
