HCW Biologics Receive FDA Clearance For Alopecia Areata Trial

HCW Biologics has received FDA clearance to start a first-in-human safety trial for their potential alopecia areata treatment, HCW9302. 

Who Are HCW Biologics?

HCW Biologics Inc. is a clinical-stage biopharmaceutical company based in Miramar, Florida. The company focuses on developing immunotherapies targeting chronic inflammation in age-related diseases like cancer, autoimmune disorders, and neurodegenerative conditions. The company employs two proprietary drug discovery platforms: the TOBI (Tissue factOr-Based fusIon) platform and the newer TRBC platform, enabling multi-functional immunotherapeutic molecules.

What Is HCW9302?

HCW9302 is the company’s lead candidate for alopecia areata, developed using the TOBI platform. This injectable interleukin-2 (IL-2) fusion protein selectively activates regulatory T cells (Treg) to suppress the autoimmune response that leads to hair loss. 

Treg cells play a dual role in hair loss (particularly in alopecia areata), maintaining immune tolerance and directly activating hair follicle stem cells for regeneration. However, their dysfunction can lead to immune dysregulation, loss of stem cell activation, and deficits in skin-specific Tregs, which lead to localized inflammation and hair loss.

The first-in-human study will determine a safe dose of HCW9302 that effectively increases Treg cells in patients with moderate-to-severe alopecia areata.

Reflections

Studies show that restoring Treg function or numbers has halted hair loss in preclinical models, highlighting their therapeutic potential, so it will be interesting to see how these first-in-human trials go.

We previously highlighted other research (OG6) that induced Treg migration in mice. However, we have not heard any further news about that since.

Let us know what you think about this news in the comments.