Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 132

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 7
Chunk 132
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2020, granting Wugen Inc. (“Wugen”) limited rights to develop cell-based immunotherapeutic treatments for cancer indications using HCW9206 and HCW9201.  WU-NK-101, the Wugen product developed using the licensed molecules, is now being evaluated in a Phase 2 clinical study in solid tumors.  ImmunityBio controls the supply of HCW9218, and one of the critical components of continuing our development of HCW9218 is successfully obtaining a supply agreement with ImmunityBio.  

In the fourth quarter of 2024, we revealed a new drug discovery and development platform, with a novel scaffolding or “backbone” of proteins called T-cell Receptor β Chain constant region (“TRBC”).  The TRBC platform leverages our in-depth knowledge of T cell and natural killer (“NK”) cell immunology.  We have developed molecules in each of these classes for treatments of hematologic and solid tumors, virally infected cells, and cellular senescence diseases associated with aging.  TRBC Molecules are grouped into three classes, based on their utilities:  Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors and Multi-Specific Targeting Fusions; and Class III: Enhanced Immune Cell Engagers.  The Company is making an efficacy assessment using relevant animal models, by the end of 2025, results of these studies are expected to show the optimal construction for lead product candidates(s).    

With clarity on ownership of intellectual property, the Company reassessed its clinical development pipeline and the future direction of our Company.  Our expertise is in immunotherapeutic treatments and our clinical development pipeline will remain so.  Our focus continues to be to develop protein-based immunotherapies that are administered by subcutaneous injection.  We remain focused on diseases promoted by chronic inflammation driven by senescence, including cancer, especially age-related diseases.  The diseases we will target will have no curative FDA approved treatments.  Finally, we have selected programs that include life-threatening diseases, such as pancreatic and ovarian cancer, as well as “quality-of-life” indications, such as alopecia areata and senile lentigo.  HCW9302 will remain one of our lead product candidates.  Future drug discovery and new drug development will be based on TRBC Molecules.  There are several potential candidates in each class of TRBC Molecules from which the Company will select lead molecules for