Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 16

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 16
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 the paper.  

For information about the bi-specific TOBI fusion, HCW9302, and its effects on Treg responses in an inflammatory disease, see Frontiers in Immunology, “A Novel Interleukin-2-Based Fusion Molecule, HCW9302, Differentially Promotes Regulatory T Cell Expansion to Treat Atherosclerosis in Mice,” Zhu, X., et al., January 2023.  The reference to our paper does not constitute incorporation by reference of the information contained in the paper.

Autoimmune and Proinflammatory Diseases

HCW9302

HCW9302 is our leading clinical-stage drug candidate designed to address chronic inflammatory responses and associated tissue destruction typical of autoimmune disease. Thus, we selected an autoimmune disease as the gateway indication for the clinical development of HCW9302.  HCW9302 is designed to activate and expand Treg cells, suppressing the persistently activated immune cells, inflammasome-bearing cells and their inflammatory factors. Preclinical studies show it has a 1,000-fold higher affinity for IL2Rα than IL-2, with a longer serum half-life. It is well tolerated, effectively expanding Treg cells without activating CD4+ effector T cells (“Teff” cells).  

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In a dose toxicity study in non-human primates, we established that HCW9302 induced Treg cell proliferation and accumulation at a dose level with no observed adverse events.  For this study, HCW9302 was administered monthly via subcutaneous injection for six months. Findings from this IND-enabling study contributed to the development of the clinical strategies for HCW9302 in autoimmune disease indications.

Alopecia Areata

On January 28, 2025, the Company obtained clearance from the FDA to evaluate HCW9302 in a Phase 1 clinical trial in patients with alopecia areata (“alopecia”).  In preclinical studies using an alopecia murine model, treatment with HCW9302 protected mice from disease, reducing pathogenic immune cell populations in the skin and skin-draining lymph nodes. HCW9302 treatment also led to a protective shift in Treg : Teff  balance, with Treg cells dominating in the skin leading to suppression of unwanted autoimmune activity. These findings suggest HCW9302-induced Treg expansion can alter the course of alopecia areata and promote tolerance, warranting further studies in human patients.

Alopecia is characterized by hair loss in localized areas, the entire scalp