REDWOOD CITY, Calif. — Hinge Bio, Inc., a privately-held clinical-stage biotechnology company focused on the discovery and development of innovative antibody therapeutics, referred to as “GEM-DIMERs™”, announced the successful dosing of the first participants in one of its Phase 1 clinical trials of HB2198, the Company’s lead multispecific product candidate targeting both CD19 and CD20, with enhanced dual Fc domains. Hinge Bio has initiated two Phase 1 clinical trials of HB2198, one study in SLE patients, and another in normal healthy volunteers.
This Phase 1 dose-escalation trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamic activity of HB2198 treatment in healthy volunteers. Preclinical studies demonstrated robust and deep B cell depletion in blood and tissues, which supported the clinical evaluation of HB2198 at the planned dose levels and regimens.
“With HB2198, our therapeutic goal is to achieve immunological remission through rapid and deep B cell depletion without T cell activation and associated cytokine release, thereby providing clinical efficacy with a better safety profile versus CAR-T or T cell engager approaches,” said Paul Brunetta, M.D., Chief Medical Officer at Hinge Bio. Dr. Brunetta added, “The Phase 1 healthy volunteer population allows us to dose escalate efficiently, and importantly, evaluates the potential safety advantages of HB2198 and supports expansion into additional B cell-mediated autoimmune diseases beyond SLE.”
“This first-in-human dosing 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 clinically with the belief that a safe, off-the-shelf B cell depleting therapy administered in an outpatient setting will provide meaningful benefits to patients.”
About HB2198 in B cell-Mediated Autoimmune Diseases
Emerging clinical evidence supports the concept that deeper tissue B cell depletion associates with greater efficacy for patients living with a variety of autoimmune disorders. HB2198 seeks to treat B cell-mediated autoimmune disorders by targeting both CD19 and CD20 with enhanced engagement of immune effector cells without activating the T cells that limit the safety and utility of other current approaches. Preclinical studies have demonstrated potent depletion of both peripheral and tissue resident B cells in vivo. The therapeutic goal of HB2198 is to achieve an immunological remission through rapid and deep B cell depletion, with the safety, convenience, accessibility, and cost 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 preclinical in vivo proof of concept to deeply deplete peripheral blood and tissue B cells with a promising safety profile. The therapeutic goal of HB2198 is to achieve an immunological remission 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 has initiated two Phase 1 clinical trials of HB2198, one study in SLE patients and one study in normal healthy volunteers.
About Hinge Bio
Hinge Bio, Inc. is a privately held clinical-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 diseases. The GEM-DIMER™ platform enables the creation of multivalent, multi-specific antibody-based therapeutics that are designed for enhanced biological activity and unique functionality. Hinge Bio is advancing a pipeline of programs with an initial focus on autoimmune disease. Learn more at www.hingebio.com.
Contact
Meru Advisors on Behalf of Hinge Bio
Patrick Till
[email protected] or [email protected]