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MIRAMAR, Fla. - HCW Biologics Inc. (NASDAQ:HCWB) announced Tuesday that the first patient has been dosed in its Phase 1 clinical trial evaluating HCW9302 for alopecia areata at The Ohio State University Wexner Medical Center.
HCW9302 is a subcutaneously injectable interleukin-2 fusion molecule designed to activate and expand regulatory T cells (Treg cells), which control excessive inflammation caused by other immune cells. The company developed the drug using its TOBI platform technology.
The multi-center dose-escalation study aims to treat up to 30 patients with alopecia areata, an autoimmune condition that causes sudden hair loss. Primary objectives include evaluating safety and determining the recommended dose for future clinical studies.
"While not life-threatening, alopecia areata has no cure. For those who suffer from the burden of this disease, it can severely impact a person's quality of life and self-esteem," said Dr. Hing C. Wong, the company's Founder and CEO, in the press release.
Alopecia areata affects approximately 160 million people worldwide, including about 7 million in the United States, according to the National Alopecia Areata Foundation. The condition impacts roughly 2% of the global population at some point in their lifetime.
The company stated that following this initial trial, it hopes to expand clinical development of HCW9302 to Phase 2 studies in alopecia areata and other autoimmune diseases, including vitiligo and atopic dermatitis. HCW Biologics also plans to explore the drug's potential in inflammatory conditions such as graft versus host disease and neurodegenerative diseases like Alzheimer's.
The announcement comes after the 2025 Nobel Prize in Physiology or Medicine recognized the discovery of Treg cells' critical function in preventing immune cells from attacking the body.
In other recent news, HCW Biologics Inc. has been granted an extension by the Nasdaq Hearings Panel to regain compliance with the exchange's listing requirements. This follows a hearing where the company presented its plan to address non-compliance with the Nasdaq Equity Rule. Additionally, HCW Biologics and WY Biotech Co. are in discussions to amend their license agreement, as WY Biotech has yet to fulfill a $7 million upfront license fee. In a significant development, HCW Biologics announced the successful creation of a second-generation pembrolizumab-based immunotherapy, demonstrating improved effectiveness against solid tumors in preclinical studies.
Meanwhile, Wugen, Inc. raised $115 million in equity financing, led by Fidelity Management & Research Company. The funding round saw participation from several investment firms, including RiverVest Venture Partners and Lightchain Capital. This infusion of capital is expected to support Wugen's development of off-the-shelf cell therapies. These recent developments highlight key financial and strategic movements within both companies.
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