HB2198 / Hinge Bio, Kyorin - LARVOL DELTA

HB2198: A Tetravalent Bispecific anti-CD19/CD20 Antibody with Dual Fc Domains for Enhanced Immune Effector Functions and Deep B Cell Depletion in SLE (ACR Convergence 2026) - No abstract available

Bispecific • Inflammatory Arthritis

Hinge Bio…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 (GlobeNewswire) - "First-in-human clinical trial underway to evaluate safety, tolerability and pharmacodynamic activity of HB2198 in normal healthy volunteers. A separate Phase 1 trial evaluating HB2198 in patients with Systemic Lupus Erythematosus (SLE) is open to screening."

Trial status • Systemic Lupus Erythematosus

Single Ascending Dose Study of HB2198 in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Hinge Bio | Not yet recruiting ➔ Recruiting

Enrollment open

A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Hinge Bio

New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Single Ascending Dose Study of HB2198 in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Hinge Bio

New P1 trial

Topologically Engineered, Superdimeric α-CD19 x α-CD20 Bispecific Antibodies with Dual Enhanced Fc Domains: New Class of Natural Killer (NK)/Monocyte Engagers for Deep B Cell Depletion in Lupus Nephritis (KIDNEY WEEK 2025) - "These include NK/monocyte engagers (i.e., CD16a engagers) comprising two α-CD19 (huFMC63) and two α-CD20 (rituximab) targeting domains, and two Fc domains incorporating S239D/I332E mutations that enhance Fcγ receptor binding. First-in-human trials are anticipated in 2025. GEM-DIMER TM technology used to create clinical candidate HB2198"

IO biomarker • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus • CD20 • FCGR3A

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 (GlobeNewswire) - "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."

IND • New P1 trial • Lupus Nephritis • Systemic Lupus Erythematosus

Hinge Bio…announced it has entered into a collaboration and license agreement with Kyorin Pharmaceutical Co., Ltd ('Kyorin') for development of Hinge Bio’s multispecific antibody-based therapeutic HB2198 in Japan for multiple autoimmune indications, starting with Systemic Lupus Erythematosus ('SLE') (GlobeNewswire) - "Hinge Bio to receive $10 million upfront and is eligible to receive $95 million for the SLE indication and additional payments for other indications; includes contingent R&D investment, tiered sales royalties, and a portion of investment to global development....Hinge Bio’s lead candidate from its GEM-DIMER platform, HB2198, is expected to enter clinical development during 2H 2025."

Licensing / partnership • New trial • Systemic Lupus Erythematosus

Hinge Bio, Inc…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. (The Manila Times)

Preclinical • Systemic Lupus Erythematosus

Anti-CD19/CD20 bispecific antibody with dual Fc domains mediates enhanced effector functions and durable depletion of memory B cells in vivo. (PubMed, Sci Rep) - "HB2198 incorporates Fab domains from rituximab and humanized FMC63 (huFMC63) for bivalent binding of both CD19 and CD20 and comprises two enhanced Fc domains to enable powerful effector functions via bivalent binding of Fcγ receptors (FcγR). In cynomolgus monkeys, HB2198 administration resulted in > 99% depletion of circulating B cells within 1-3 days and mediated a durable shift in proportions of naïve and memory B cells in vivo. These data support the conclusion that HB2198 may provide an improved treatment option when potent and broad depletion of both CD19+ and CD20+ cells is required."

Journal • Preclinical • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Oncology

Hinge Bio Raises $30 Million Series A’ Financing to Develop Next-Generation Therapies via its Proprietary GEM-DIMER Platform (GlobeNewswire) - "Hinge Bio, Inc...today announced the close of a Series A’ financing led by Point72...The proceeds will support entry of the Company’s lead product candidate, HB2198, into a Phase 1 clinical trial in patients living with Systemic Lupus Erythematosus ('Lupus') as well as development of additional therapeutics from Hinge Bio’s proprietary GEM-DIMER platform to treat diseases with high unmet need...Hinge Bio’s lead candidate from its GEM-DIMER platform, HB2198, is expected to enter clinical development during 2025."

Financing • New P1 trial • Systemic Lupus Erythematosus