Agreement includes pre-payment commitments for product sales and distribution of the second-generation multi-cytokine-based HCW11-006 for use as a reagent

Akron is a leading supplier of critical ancillary materials and accessory molecules for clinical and commercial scale-up of cell, gene and regenerative therapy products

HCW Biologics supplies research and cGMP-grade HCW11-006 and Akron markets and distributes the reagent to its established network of research institutions and commercial companies

Company showed in studies that CAR-T cells manufactured using HCW11-006 as a reagent exhibited strong anti-tumor activity and enhanced antiviral potency as well as potential for lowering the cost of production of CAR-T therapies

HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on developing novel fusion immunotherapeutics to treat autoimmune diseases, cancer, and senescence-associated dysplasia, announced  that the Company has entered into an Exclusive Distribution Agreement with Akron Biotech (“Akron”), a leading manufacturer of ancillary materials and a contract development and manufacturing organization for the cell, gene therapy, and regenerative medicine industries, for the commercialization of HCW11-006 for use as a reagent to support a new method of producing highly functional human CAR-T cells for treating cancer, autoimmune disease, and infectious diseases. Akron operates within a highly specialized global network of biomedical institutions, primarily catering to a customer base of advanced therapy developers, biopharmaceutical companies, and research organizations. Akron manufactures and markets cGMP-compliant ancillary materials (such as cytokines, media supplements, and plasmid DNA) necessary for bringing regenerative medicine from preclinical stages to commercialization.

HCW11-006, a first-in-class multi-cytokine fusion molecule built with our proprietary TRBC platform, enables production of more potent CAR-T-based immunotherapies by generating a CAR-T population that is highly functional and markedly enriched for long-lived T-memory stem cells (T_scm). Utilizing HCW11-006 as part of a manufacturing strategy may be broadly applicable to increase persistence and functionality of CAR-Ts. Functional persistence of CAR-Ts is limited by conventional and costly manufacturing methods utilizing anti-CD3/CD28 (αCD3/28)/IL-2 stimulation, which generates terminally differentiated and shorter-lived CAR-Ts.

Utilizing HCW11-006 as a reagent in the manufacture of CAR-Ts synergizes the effects of IL-7, IL-15 and IL-21 to promote the generation of a CAR-T cell product with a diverse mix of T cell subsets that exhibit a combination of T_scm self-renewal capacity and enhanced T cell effector function. In addition, as a reagent, HCW11-006 stimulates proliferation of CD8⁺ T cells, particularly those within the T_scm subset. As a result, HCW11-006 was shown to generate CAR-Ts without requiring αCD3/28/IL-2 activation that are highly enriched in long-lived T_scm and display potent activity across distinct disease experimental models, namely, HIV-1 and B-cell leukemia.

In preclinical studies, CAR-Ts manufactured using HCW11-006 were significantly superior compared to CAR-Ts manufactured using standard methods employing αCD3/28/IL-2 reagents for CAR lentiviral transduction and subsequent expansion and persistence of highly active human CAR-Ts. Clinical studies are planned to further confirm these findings. This research suggests that CAR-T cells produced with HCW11-006 may be a more effective and longer-lasting CAR-T cell immunotherapy than conventional CAR-T cells produced using αCD3/28/IL-2.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “We are thrilled that our first product, created using our proprietary TRBC platform, has reached the commercialization stage. HCW11-006 is a novel compound that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. It is versatile and can be used as a novel reagent to potentially replace the current industry-standard method that relies on αCD3/28/IL-2-based approaches. An approach that employs HCW11-006 as a reagent is highly streamlined and may lower the cost of CAR-T manufacturing compared to existing approaches. Equally important, based on experimental models, HCW11-006 has shown improvement in functional activities and persistence of CAR-Ts following adoptive transfer, a goal the industry has been trying to achieve for the last decade.”

Dr. Wong continued, “We are pleased to be entering into a partnership with Akron Biotech and their extensive network of customers who include leading research institutions all over the world that will include the use of CAR-T treatments produced using HCW11-006 as a reagent in clinical research and scale-up of commercialization. Recently, research laboratories and companies approached us directly seeking supply of HCW11-006 to support their cell-based research and development for their novel therapies. We decided to seek a partnership with a leading supplier to commercialize HCW11-006 for use as a reagent. We are excited to enter into this Distribution Agreement to commercialize this application of HCW11-006 as a reagent with an established firm that specializes in manufacturing and distribution of cell-based, gene and regenerative therapies.”