Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 3

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 3
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 models of dermatological conditions, graft rejection, atherosclerosis, diabetes, and neurodegenerative diseases as well as IND-enabling studies conducted in non-human primates support the clinical development of HCW9302 as a potential therapeutic agent for treatment of autoimmune and proinflammatory diseases. 

HCW9201 + HCW9206:  Novel Immunotherapeutic for Memory-Like Natural Killer Cell

On December 24, 2020, the Company entered into an exclusive worldwide license with Wugen, Inc. (“Wugen”) for ex vivo rights for two of its proprietary molecules.  Wugen is evaluating natural killer (“NK”) cell therapy generated using HCW9206 in combination with HCW9201 in clinical trials in cancer indications.  HCW9206 has a unique design consisting of a multi-functional compound constructed with three powerful cytokines:  IL-7, IL-15, and IL-21.  It is designed to stimulate T cell proliferation and activation, enhance NK cell cytotoxicity, and improve overall immune surveillance against pathogens or tumors.  

HCW9201 + HCW9206, known as WU-NK-101, is Wugen’s lead memory NK cell therapy product and is comprised of cells optimized for anti-cancer function. WU-NK-101 cells possess a unique cytokine-induced memory-like phenotype that supports enhanced anti-tumor activity, robust trafficking, superior proliferation capacity, and metabolic flexibility, all of which contribute to treatment resilience in the adverse tumor microenvironment.  Wugen is currently evaluating WU-NK-101 in a Phase 1 open-label study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of WU-NK-101 in combination with cetuximab in patients with advanced and/or metastatic colorectal cancer (Cohort 1), and in patients with advanced and/or metastatic squamous cell carcinoma of head and neck (Cohort 2). The overall study will be comprised of two phases, a Dose Escalation Phase, and a Cohort Expansion Phase.

The Company retained the in vivo rights to HCW9201 and HCW9206, as well as the manufacturing rights.  Wugen obtains clinical supply from the Company under the provisions of a development supply agreement.  

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Clinical-Stage Compound Awaiting Completion of Supply Agreement with ImmunityBio

HCW9218:  Novel Bifunctional Immunotherapeutic with TGF-β Trap

HCW9218 is