Hinge Bio Strengthens Leadership Team and Publishes Promising Data for Novel Lupus Treatment HB2198
Key Insights
Hinge Bio (search) has appointed three seasoned biotech executives to key leadership positions to advance its GEM-DIMER platform through clinical development.
The company published preclinical data in Scientific Reports demonstrating that HB2198, a novel anti-CD19 (search)/CD20 (search) bispecific antibody, achieves durable depletion of memory B cells in vivo.
HB2198 is designed to treat B cell-mediated autoimmune disorders including systemic lupus erythematosus and is expected to enter clinical trials in the second half of 2025.
Hinge Bio (search), a privately-held biotechnology company, has significantly strengthened its leadership team with the appointment of three experienced biotech executives while simultaneously publishing promising preclinical data for its lead therapeutic candidate HB2198 in Scientific Reports. The dual announcements position the company to advance its novel GEM-DIMER platform toward clinical development for treating autoimmune diseases, particularly systemic lupus erythematosus (SLE).
Leadership Expansion Drives Clinical Development
The company has appointed Paul Brunetta, M.D., as Chief Medical Officer, bringing extensive experience from his previous roles at Sana Biotechnology, Juno Therapeutics (search), and a 15-year tenure at Genentech where he served as Global Head of the Anti-CD20 (search) Immunology Program. Dr. Brunetta was responsible for designing and implementing clinical trials in autoimmune drug development spanning phase I-IV across multiple therapeutic areas including neurology, nephrology, rheumatology, and immunology.
Kristen Quigley joins as Chief Clinical Operations Officer, contributing 29 years of clinical research expertise with 26 years governing phase I-IV clinical trials. Her experience spans autoimmune, renal failure, and oncology indications, with previous executive roles at Molecular Templates, Inc., Threshold Pharmaceuticals, and ICON plc.
Alpana Naresh, Ph.D., has been appointed Vice President and Head of CMC Strategy and Manufacturing. Dr. Naresh brings over 25 years of research and development experience with multiple biomolecules, including her recent role as Executive Director of CMC Operations at Harpoon Therapeutics and subsequently Merck (search) following the acquisition.
"We are excited to expand our management team with seasoned biotech leaders to drive our novel GEM-DIMER programs through clinical development," said Chief Executive Officer Barry Selick, Ph.D.
Scientific Publication Validates HB2198 Mechanism
The publication in Scientific Reports presents differentiated in vivo data demonstrating durable depletion of memory B cells with HB2198, a novel anti-CD19 (search)/CD20 (search) bispecific antibody featuring dual Fc domains. According to Chief Development Officer Juha Punnonen, M.D., Ph.D., "HB2198 administration resulted in rapid depletion of memory B cells and mediated a durable shift in proportions of naïve and memory B cells."
The depletion of memory B cells represents a critical surrogate for efficacy in multiple autoimmune disorders, including SLE. Dr. Punnonen noted that "the data suggest HB2198 could be an important therapeutic option for multiple B cell mediated autoimmune disorders."
Clinical Development Timeline and Therapeutic Approach
HB2198 is expected to enter clinical development during the second half of 2025, with the first clinical trial planned to treat SLE. The program seeks to treat B cell-mediated autoimmune disorders by targeting both CD19 (search) and CD20 (search) with enhanced engagement of immune effector cells.
Preclinical studies have demonstrated potent depletion of human B cells in vitro and deep depletion of B cells in vivo in non-human primates. The therapeutic candidate has shown the ability to rapidly and deeply deplete more than 99% of B cells, according to company data.
Differentiated Platform Technology
The therapeutic goal of HB2198 is to achieve an "immune system reset" through rapid and deep B cell depletion in both peripheral blood and lymphoid tissues. The company emphasizes that this approach offers the convenience, accessibility, cost and safety benefits of an off-the-shelf antibody-based therapeutic without the challenges and toxicities associated with CAR-T or T cell engagers.
Hinge Bio (search)'s proprietary GEM-DIMER platform enables the creation of multivalent, multispecific antibody-based therapeutics designed to bind their targets cooperatively, allowing for enhanced biological activity and unique functionality. The platform is being developed to address problems of inadequate efficacy, resistance, and side effects in autoimmunity, inflammatory disease, and cancer.
The new leadership team expressed enthusiasm for advancing the company's mission. "We are incredibly excited to join Hinge Bio (search) and contribute to its mission by advancing novel multi-specific GEM-DIMER programs into and through clinical development," the three new executives stated jointly. "Hinge Bio's groundbreaking approach represents a major step forward for differentiated off-the-shelf multi-specifics to address significant unmet medical needs in autoimmunity, inflammatory disease, and cancer."