HCW Biologics hands Phase I development of tri-specific fusion immunotherapeutic to China’s Trimmune

HCW Biologics Inc. (NASDAQ: HCWB), a Florida-based biopharma, has closed an exclusive worldwide license for HCW11-006, a preclinical fusion immunotherapeutic, signed with Beijing Trimmune Biotech Co., Ltd. Trimmune is a newly formed entity established by WY Biotech Co., Ltd., a China-based recombinant protein and gene/cell therapy developer, and HCW Biologics. The license deal grants Trimmune rights to develop and commercialize HCW11-006 globally, with a Phase I clinical study in China expected in the first half of 2027. Trimmune will bear all costs associated with that trial, as per the deal announcement.

The deal terms include an upfront payment of USD 7.0 million, comprised of USD 3.5 million in cash and USD 3.5 million of equity in Trimmune. HCW Biologics is also eligible for development milestone payments along with double-digit royalties on future product sales. The company is further entitled to a portion of proceeds from any future transactions involving the licensed molecule. Financial terms beyond these categories were not disclosed. Trimmune’s investors include CITIC Medical Fund and TigerYeah Capital Fund of TigerMed.

A structural element of this immunotherapy licensing deal is a payment-free, milestone-free, and royalty-free option retained by HCW Biologics to recapture all rights for in vivo applications of HCW11-006 in the United States, Canada, Central America, and South America. That option becomes exercisable after the conclusion of the Phase I clinical trial in China. This provision means HCW Biologics could regain the Americas territory without additional cost, using Trimmune-funded Phase I data to inform its decision. The deal also provides Trimmune with an option to license exclusive regional China rights to HCW9302, a separate clinical-stage molecule from HCW Biologics currently in a Phase I study in alopecia areata (NCT07049328).

Deal context

HCW11-006 is a multi-functional fusion protein biologic generated from HCW Biologics’ proprietary TRBC drug discovery and development platform. The company has stated it has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-018, and HCW11-040, though clinical details on those assets have not been disclosed. HCW Biologics HCW11-006 is designed to integrate functional domains of interleukin-12, interleukin-15, and a PD-L1 blocking component into a single engineered construct. The molecule is intended to simultaneously activate natural killer cells and T cells through cytokine receptor signaling while blocking the PD-1/PD-L1 immune checkpoint axis. No clinical trials for HCW11-006 are currently registered on clinicaltrials.gov. The asset remains in preclinical development.

The HCW Biologics exclusive license agreement fits within the company’s stated strategy of using business development to finance clinical programs. HCW Biologics operates a second platform, TOBI, which generated HCW9302 and HCW9218, a fusion protein that has been in a Phase 1b study in advanced pancreatic cancer. The TRBC platform, from which HCW11-006 originates, is focused on multi-specific immunotherapeutic molecules, including second-generation T-cell engagers designed for solid tumors.

Several companies are developing engineered cytokine therapies and immunocytokines targeting similar immune activation pathways. These include bifunctional cytokine constructs such as Sonnet BioTherapeutics’ IL-12/IL-15 fusion, IL-15–based agonists such as ImmunityBio’s approved Anktiva, and conditionally activated cytokine platforms from Werewolf Therapeutics.

HCW11-006 differs in that it is designed as a multi-functional fusion protein incorporating cytokine signaling domains alongside checkpoint blockade within a single molecule. This “all-in-one” approach aims to replicate combination immunotherapy effects in a single construct.