Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 5

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 5
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 who participated in the study showed evidence of stable disease. 

The Company had the non-exclusive rights to develop HCW9218 treatment for ovarian cancer in a neoadjuvant setting, based on a Phase 2 clinical study sponsored by the University of Pittsburgh Medical Center (“UPMC”).  Under the terms of the Settlement Agreement, UPMC had until year end of 2024 to launch this study, but failed to do so. Thus, the Company terminated this study. 

Under the Settlement Agreement, the Company agreed to transfer the HCW9218 master cell line to ImmunityBio.  In turn, ImmunityBio agreed to enter into a supply agreement with the Company by the end of January 2025 to ensure the Company had adequate clinical supply of HCW9218 available to carry on clinical studies.  As of the reporting date, a draft of the supply agreement has not been provided by ImmunityBio.  Until the supply agreement is in place, any plans for our further development of HCW9218 must be delayed. 

Preclinical Compounds

HCW11-006:  Multi-Functional Immune Cell Stimulator

This product candidate is the subject of the exclusive worldwide license agreement the Company entered with WY Biotech Co., Ltd. (“WY Biotech”), a China-based company specializing in the early-stage development of recombinant protein drugs and gene/cell therapies, on November 17, 2024 (the “WY Biotech License”).  Under the WY Biotech License, WY Biotech has rights to in vivo applications for HCW11-006.  The Company retains ex vivo rights.  Under the terms of the WY Biotech license agreement, the Company has an “opt-in right” for United States, Canada, Central America, and South America markets for no cost, that may be exercised after the completion of a Phase 1 trial in China.  WY Biotech is responsible for all of the costs for the Phase 1 clinical study. 

HCW11-006 was constructed using the TRBC drug development platform.  It combines several different immune functional domains on our new protein scaffold platform as part of our Class I portfolio. Our preclinical studies demonstrated that this multi-functional product candidate is highly effective at inducing CD8+ T cell and NK cell responses without triggering unwanted side effects in human immune cell and animal models. HCW11-006 also exhibited anti-tumor efficacy in relevant solid tumor animal models. We believe it has the potential to be