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Hinge Bio Expands Leadership Team to Drive Clinical Development of GEM-DIMER™ Programs and Announces Publication in Scientific Reports

Paul Brunetta, M.D., joins as Chief Medical Officer; Kristen Quigley joins as Chief Clinical Operations Officer; Alpana Naresh, Ph.D., joins as Vice President and Head, CMC Strategy and Manufacturing

Hinge Bio publishes differentiated in vivo data demonstrating durable depletion of memory B cells with HB2198, a novel anti-CD19/CD20 bispecific antibody with dual Fc domains in Scientific Reports (https://www.nature.com/srep/)

BURLINGAME, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) --  Hinge Bio, Inc., a privately-held biotechnology company engaged in the discovery and development of innovative multi-specific medicines, announced it has expanded its leadership team with experienced biotech executives and has published preclinical proof-of-concept data from its lead program, HB2198, designed to provide deep depletion of B cells to treat autoimmune diseases including Systemic Lupus Erythematosus (“Lupus” or “SLE”) in Scientific Reports.

“Hinge Bio is committed to developing life-changing medicines for patients with intractable diseases,” said Chief Executive Officer Barry Selick, Ph.D. “We are excited to expand our management team with seasoned biotech leaders to drive our novel GEM-DIMERTM programs through clinical development. We also appreciate the recognition by Scientific Reports of the differentiated efficacy data demonstrated with HB2198 to durably deplete memory B cells, which is evidence of a key mechanism of action for multiple autoimmune indications, including SLE.”

In a joint statement, Dr. Brunetta, Ms. Quigley, and Dr. Naresh added: “We are incredibly excited to join Hinge Bio and contribute to its mission by advancing novel multi-specific GEM-DIMERTM programs into and through clinical development. 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.”

Paul Brunetta, M.D., joins Hinge Bio as Chief Medical Officer. Dr. Brunetta was most recently at Sana Biotechnology as Senior Vice President of Clinical and Translational Science and remains Adjunct Associate Professor in the Pulmonary and Critical Care Division at University of California, San Francisco (UCSF). Previously Dr. Brunetta was Senior Vice President of Translational Science at Juno Therapeutics. Prior to Juno, he was at Genentech for 15 years where he was the Global Head of the Anti-CD20 Immunology Program. At Genentech, Dr. Brunetta was responsible for designing, monitoring and implementing clinical trials in autoimmune drug development spanning phase I-IV in neurology, nephrology, rheumatology, immunology, pulmonary medicine and solid organ transplantation. Dr. Brunetta also directed the Genentech Clinical Research Fellowship program for 12 years. Dr. Brunetta is a graduate of Johns Hopkins University in Baltimore and Tufts University School of Medicine in Boston. He came to UCSF at the height of the AIDS epidemic in 1990 and did his internship and medical residency at UCSF. Dr. Brunetta was Chief Medical Resident at San Francisco General Hospital and completed his Pulmonary and Critical Care Fellowship at UCSF before joining the faculty.

Kristen Quigley joins Hinge Bio as Chief Clinical Operations Officer. Ms. Quigley has 29 years of clinical research expertise, including 26 years governing phase I-IV clinical trials and 9 years serving in executive leadership roles. She has a proven track record of building company value via commitment to evolving with organizations, functioning in long-standing senior leadership and executive roles at both biotech companies and CROs. Her disease experience includes autoimmune, renal failure, and myriad oncology indications. Ms. Quigley previously served in COO, SVP, and VP roles at two biotech companies, Molecular Templates, Inc. and Threshold Pharmaceuticals. During her tenure at a large global CRO, ICON plc, she also co-directed the Nordic region and governed large trial portfolios for several clients. Ms. Quigley holds a bachelor’s degree from Washington University in St. Louis.

Alpana Naresh, Ph.D., joins Hinge Bio as Vice President, CMC Strategy and Manufacturing. Dr. Naresh was most recently the Executive Director of CMC Operations at Harpoon Therapeutics, Inc and subsequently Merck, following Merck’s acquisition of Harpoon. At Harpoon, Dr. Naresh worked on the development, transfer, and manufacturing of novel T-cell engager molecules (Tri-specific T cell Activating Construct (TriTAC®) platform and ProTriTAC™ platform).  Previous positions included roles at Boehringer Ingelheim, JSR Life Sciences, Sutro Biopharma, Genitope, and post-doctoral fellowships at Stanford University and University of Virginia. Dr. Naresh is a collaborative, results driven biotechnology professional with more than 25 years of research and development experience with multiple biomolecules including immunoglobulins as personalized vaccines for cancer; monoclonal antibodies; bispecific antibodies; trispecific modalities. Dr. Naresh received her Masters in Biotechnology from CCSHAU and Doctor of Philosophy in Biotechnology from IMTech, Chandigarh and was post-doctoral fellow at Stanford University in Professor Cleary’s lab. 

Regarding the publication in Scientific Reports, Chief Development Officer Juha Punnonen, M.D., Ph.D., said: “We are honored to have data on HB2198 published and reviewed by expert peers of Scientific Reports. The manuscript highlights the unique potential of HB2198 to durably impact the phenotype of B cells in vivo. 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 is a critical surrogate for efficacy in multiple autoimmune disorders, including SLE, and the data suggest HB2198 could be an important therapeutic option for multiple B cell mediated autoimmune disorders.”

Hinge Bio’s lead candidate from its GEM-DIMERTM platform, HB2198, is expected to enter clinical development during 2H 2025. The program seeks to treat B cell-mediated autoimmune disorders by targeting both CD19 and CD20 with enhanced engagement of immune effector cells. Pre-clinical 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 goal of HB2198 is to achieve a reset of the immune system through rapid and deep B cell depletion in both peripheral blood and lymphoid tissues, with the convenience, accessibility, cost and safety benefits of an off-the-shelf antibody-based therapeutic.

About HB2198

Hinge Bio’s lead program HB2198, from its proprietary GEM-DIMERTM platform, is designed to improve efficacy, safety, and convenience for the treatment of B cell-mediated autoimmune disorders, such as Systemic Lupus Erythematosus (SLE). HB2198 has demonstrated in vivo proof of concept to rapidly and deeply (>99%) deplete B cells. The therapeutic goal of HB2198 is to achieve a “reset” of the immune system through rapid and deep B cell depletion in both peripheral blood and lymphoid tissues, without the challenges and toxicities associated with CAR-T or T cell Engagers (TCEs). Hinge Bio anticipates opening a clinical trial in 2H 2025 to first treat SLE.

About Hinge Bio

Hinge Bio, Inc. is a privately held development-stage biotechnology company leveraging its proprietary GEM-DIMER™ platform to design and develop the next generation of therapeutics to address the problems of inadequate efficacy, resistance, and side effects in the fields of autoimmunity, inflammatory disease, cancer, and other disease. The GEM-DIMER™ technology platform enables the creation of multivalent, multispecific antibody-based therapeutics that are designed to bind their targets cooperatively allowing for enhanced biological activity and unique functionality. Hinge Bio is advancing a pipeline of programs with an initial focus on autoimmune disease.

Contact:                                                                            

Meru Advisors on Behalf of Hinge Bio:

Patrick Till

ptill@meruadvisors.com or info@hingebio.com 

Learn more at www.hingebio.com.


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