CLYM116 / Climb Bio, Beijing Mabworks Biotech - LARVOL DELTA

CLYM116, a Novel 'Sweeper' Anti-APRIL mAb: Extrapolation of PK and Ig Suppression from NHPs to Healthy Volunteers and Initial Phase 1 Data (ERA 2026) - P1 | "CLYM116 was safe and well tolerated in healthy adult volunteers in the initial cohorts of the Phase 1 study. These emerging data support continued clinical evaluation of CLYM116 as a potential best-in-class, disease-modifying treatment for IgAN."

Clinical • P1 data • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

Climb Bio to Present on CLYM116 and Budoprutug Programs at European Renal Association (ERA) Congress 2026 (GlobeNewswire) - "Climb Bio will present pharmacokinetic/pharmacodynamic modeling from nonhuman primates to humans for CLYM116, a novel ‘sweeper’ anti-APRIL monoclonal antibody, which is being developed to treat IgA nephropathy (IgAN). Initial safety data from the ongoing CLYM116 Phase 1 study in healthy volunteers will also be presented....The Company will also present a trial-in-progress poster for PrisMN, its ongoing Phase 2 study of budoprutug, a novel anti-CD19 monoclonal antibody, in primary membranous nephropathy (pMN)."

P1 data • Trial status • IgA Nephropathy • Nephrology

A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy. (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • IgA Nephropathy • Renal Disease

Negative-Linear-Compressibility-Driven Structural Rigidification Enables High-Efficiency Blue Emission in MIL-116(Al). (PubMed, Nano Lett) - "Consequently, pressure-treated MIL-116(Al) displays bright-blue emission, with its photoluminescence quantum yield increasing from 4.5% to 60.7%. These results establish a new paradigm for optimizing the performance of photofunctional MOFs with broad implications for optoelectronic applications."

Journal

A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy. (clinicaltrials.gov) - P1/2 | N=130 | Not yet recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd.

New P1/2 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Phase 1 Study of CLYM116 in Normal Healthy Volunteers (clinicaltrials.gov) - P1 | N=58 | Recruiting | Sponsor: Climb Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human

A Phase 1 Study of CLYM116 in Normal Healthy Volunteers (clinicaltrials.gov) - P1 | N=58 | Not yet recruiting | Sponsor: Climb Bio, Inc.

New P1 trial

Development and Characterization of CLYM116, a Novel Fc-Engineered Anti-APRIL Monoclonal Antibody (mAb) with pH-Dependent Binding for IgAN (KIDNEY WEEK 2025) - "IND-enabling NHP studies are currently underway. CLYM116’s unique profile may provide robust inhibition of APRIL signaling with potential impact on IgAN pathophysiology."

Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

CLYM116: anti-APRIL monoclonal antibody for IgAN and other B-cell mediated diseases. (GlobeNewswire) - "IND-enabling studies for CLYM116 are ongoing and the Company expects to share initial preclinical data from this program in the second half of 2025."

Preclinical • IgA Nephropathy

Climb Bio Expands Pipeline Through an Exclusive License to Develop and Commercialize an Antibody Targeting the APRIL Pathway for IgA Nephropathy (GlobeNewswire) - "Climb Bio, Inc...today announced it has entered into an exclusive license agreement with Beijing Mabworks Biotech Co., Ltd...for rights to develop and commercialize MIL116 (now CLYM116), an anti-APRIL (A PRoliferation-Inducing Ligand) monoclonal antibody, in the territory outside of Greater China. Climb Bio believes CLYM116 is a potential best-in-class approach to address significant unmet need in patients with IgA nephropathy and other B-cell mediated diseases... CLYM116 is currently in IND-enabling studies, and Climb Bio plans to share data from the ongoing preclinical studies later in 2025...Under the terms of the agreement, Climb Bio will make an upfront cash payment of $9 million to Mabworks, and will be required to make certain additional payments upon the achievement of specified development, regulatory and commercial milestones, and pay low- to mid-single digit tiered royalties on net sales outside of Greater China."

Licensing / partnership • Preclinical • IgA Nephropathy