Hinge Bio Announces FDA Clearance of Investigational New Drug Application for HB2198, a Novel B cell-Depleting Agent, for Patients with Systemic Lupus Erythematosus and Lupus Nephritis
Phase 1 trial to investigate novel multi-specific HB2198 to treat B cell-mediated autoimmune disorders by targeting both CD19 and CD20 plus enhanced immune cell engagement via dual Fc domains
BURLINGAME, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Hinge Bio, Inc., a privately-held biotechnology company engaged in the discovery and development of innovative multi-specific medicines, announced the U.S. Food and Drug Administration (“FDA”) has cleared the company’s Investigational New Drug (“IND”) application to initiate a study of HB2198 in patients with the B cell-mediated autoimmune diseases Systemic Lupus Erythematosus (“SLE”) and Lupus Nephritis (“LN”).
“This IND clearance marks a significant milestone for Hinge Bio and our mission to develop innovative therapies to improve the lives of patients suffering from Lupus and other B cell-mediated diseases with high unmet medical need.” said Chief Executive Officer Barry Selick, Ph.D. “We are excited to advance HB2198 into the clinic with the belief that a safe, off-the-shelf B cell-depleting therapy will provide meaningful benefits to patients.”
Juha Punnonen, M.D., Ph.D., Hinge Bio’s Chief Development Officer, added: “The IND for HB2198 was supported by a robust preclinical package which demonstrated a differentiated preclinical efficacy and safety profile with durable depletion of memory B cells, evidence of a key mechanism of action underlying “immune reset” for potentially treating a variety of autoimmune indications.”
About HB2198 in B cell-Mediated Autoimmune Diseases
Emerging data in the field support the concept that deeper tissue B cell depletion can be associated with greater efficacy and an acceptable safety profile. HB2198 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. 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-DIMER™ 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 4Q 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, multi-specific 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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