HCW Biologics Launches First-in-Human Trial for HW9302
Clinical Trial Initiation: HCW Biologics has commenced a first-in-human clinical trial for HCW9302 at The Ohio State University Wexner Medical Center, targeting alopecia areata, a condition affecting millions globally.
Mechanism of Action: HCW9302 is an interleukin-2 fusion molecule designed to activate and expand regulatory T cells (Treg cells), potentially reducing inflammation without broad immunosuppression.
Significance of Treg Cells: The critical role of Treg cells in controlling immune responses was recently recognized with the 2025 Nobel Prize in Physiology or Medicine, highlighting their importance in preventing autoimmune diseases.
Study Objectives: The Phase 1 study aims to assess the safety and optimal dosing of HCW9302 in up to 30 patients, with secondary goals including evaluating immune cell responses and potential future studies in other inflammatory conditions.
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Company Overview: HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to combat age-related diseases and chronic inflammation, utilizing their TRBC drug discovery platform.
Product Candidate: The company's lead product, HCW11-040, is a second-generation immune checkpoint inhibitor that combines pembrolizumab with interleukin-7, interleukin-15, and TGF-β receptor components, showing promise in expanding exhausted T cells without side effects.
Upcoming Presentation: HCW Biologics will present data on HCW11-040 at the 40th annual meeting of the Society for Immunotherapy of Cancer (SITC) on November 8, 2025, highlighting its potential as a novel tetra-specific immunotherapeutic.
Forward-Looking Statements: The company has issued forward-looking statements regarding the efficacy of its pembrolizumab-based TRBC fusion molecules, acknowledging the inherent risks and uncertainties in achieving anticipated results.

Company Overview: HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases, with a proprietary TRBC platform for creating various immunotherapeutic compounds.
Upcoming Presentations: The company will present three posters at the 40th Annual Meeting of the Society for Immunotherapy of Cancer from November 5 to 9, 2025, showcasing their lead drug candidates and their potential applications in cancer therapy.

Healthcare Spending Trends: Americans over 65 spend significantly more on healthcare annually compared to children, prompting increased investment in longevity solutions as the global population aged 60+ is expected to double by 2050.
Avant Technologies' Joint Venture: Avant Technologies has partnered with Austrianova to form Klothonova, focusing on cell-based therapies that utilize Klotho protein to target age-related diseases, positioning itself in the rapidly growing longevity biotech market.
Adobe's Strong Performance: Adobe Inc. shares rose 4.4% in pre-market trading after reporting better-than-expected Q3 earnings of $5.31 per share and revenue of $5.99 billion, along with an improved fiscal 2025 outlook.
Notable Gainers: Several stocks saw significant pre-market gains, including HCW Biologics (up 94.3%), Huize Holding (up 61.5%), and Millennium Group (up 46.2%), following positive announcements and financial results.
Major Losers: Next Technology Holding experienced a sharp decline of 50.6% due to a reverse stock split, while Rent the Runway fell 27.1% after disappointing Q2 earnings.
Market Overview: The pre-market trading session showed a mix of gains and losses across various stocks, with notable movements in both directions following recent earnings reports and company announcements.
Stock Surge: HCW Biologics Inc. (HCWB) shares rose 102.72% to $6.73 in after-hours trading after announcing the successful development of second-generation T-cell engagers for solid tumors, specifically targeting pancreatic cancer and glioblastoma.
Promising Preclinical Results: The company's lead candidate showed 100% survival rates in tumor-bearing mice, and non-human primate studies indicated it was well-tolerated without serious side effects, driving investor interest in the stock.
Partnership Strategy: HCW Biologics plans to collaborate with financially strong corporations to enhance development and market entry, aiming to tap into a lucrative market for T-cell engagers, which currently generates billions in annual sales.
Stock Performance Overview: Despite a recent surge, HCWB has experienced significant volatility, with a dramatic decline of approximately 93.4% from its peak price of $49.60 last November, and a current market capitalization of $7.14 million.

Breakthrough in Immunotherapy: HCW Biologics Inc. announced advancements in second-generation pembrolizumab-based immunotherapies, showing strong preclinical results against solid tumors like pancreatic and ovarian cancers.
Enhanced Efficacy: The company's fusion molecules demonstrated superior anti-tumor activity compared to traditional pembrolizumab monotherapy, effectively activating immune responses while neutralizing immunosuppressive factors in the tumor microenvironment.
Market Potential: CEO Dr. Hing C. Wong highlighted the multi-billion-dollar market for checkpoint inhibitors, indicating that their new therapy could significantly expand treatment efficacy and applications.
Future Developments: Dr. Wong will present findings on the IND-enabling studies at an upcoming seminar, as HCW Biologics explores potential uses of its therapy in treating age-related diseases by targeting senescent cells.






