budoprutug (TNT119) / Cancer Research UK, Climb Bio - LARVOL DELTA

A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Climb Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

First patient dosed in China Phase 1b/2a trial of budoprutug in systemic lupus erythematosus (SLE); Global Phase 1b SLE trial enrollment ongoing (GlobeNewswire) - "The parallel China Phase 1b/2a trial in SLE is anticipated to provide complementary data and will also seek to enroll SLE patients with lupus nephritis. Data from these trials are expected to provide insights into budoprutug activity and will also help to inform future development efforts for the program broadly. Anticipate data, including safety and biomarker data from the Global study in the fourth quarter of 2026."

P1 data • P1/2 data • Immunology • Systemic Lupus Erythematosus

Budoprutug Program Updates and Anticipated Milestones (GlobeNewswire) - "PrisMN Phase 2 primary membranous nephropathy (pMN) trial, enrollment ongoing...Enrollment is now ongoing in the second cohort (600 mg) and anticipate initial data, including preliminary B cell and anti-PLA2R data from low dose cohort (200mg at 12-24 weeks), at a medical meeting in the fourth quarter of 2026...Anticipate additional data from the 500 mg and 1000 mg cohorts in the fourth quarter of 2026....Plan to initiate a multiple-dose study of the SC formulation in autoimmune patients; anticipate initial data in 2027."

New trial • P1/2 data • P2 data • Trial status • Glomerulonephritis • Immune Thrombocytopenic Purpura • Immunology • Nephrology

A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Climb Bio, Inc. | Active, not recruiting ➔ Completed

Trial completion

BUDOPRUTUG, A LOW-FUCOSYLATED ANTI-CD19 MONOCLONAL ANTIBODY, IN ADULTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA: INITIAL PHASE 1B STUDY RESULTS (EHA 2026) - P1/2 | "All pts had 2-4 prior therapies within the last 2 years; 4 pts had prior rituximab and a separate pt had a splenectomy. The study is continuing with dosing in higher dose cohorts (DL2 and DL3). Additional safety and efficacy data from the study will be presented at the conference."

Clinical • P1 data • Glomerulonephritis • Hematological Disorders • Immune Thrombocytopenic Purpura • Renal Disease • Thrombocytopenia • Thrombocytopenic Purpura • CD19

PHASE 1 STUDY TO EVALUATE SUBCUTANEOUS BUDOPRUTUG, A LOW-FUCOSYLATED ANTI-CD19 MAB, IN HEALTHY VOLUNTEERS, AS A POTENTIAL TREATMENT FOR IMMUNE‑MEDIATED DISEASES WITH ADMINISTRATION OPTIONALITY (EHA 2026) - P1, P1/2 | "Acetaminophen/paracetamol and diphenhydramine were given as pre-medications. SC budoprutug showed robust effects on B-cell depletion with similar tolerability to matched-dose IV budoprutug, despite being studied at doses predicted to produce modest impact on B cells. The comparable PD between routes supports the feasibility of SC administration and provides flexibility for continued development in immune-mediated diseases."

Clinical • P1 data • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Hypotension • Immune Thrombocytopenic Purpura • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Thrombocytopenia • Thrombocytopenic Purpura • CD19 • CD20

PrisMN: Phase 2 Study to Evaluate the Safety and Efficacy of Budoprutug, a Low-Fucosylated Anti-CD19 mAb, in Primary Membranous Nephropathy (ERA 2026) - No abstract available

Clinical • P2 data • Glomerulonephritis • Renal Disease

Climb Bio Announces Initial Phase 1b Data Demonstrating On-Target Clinical Activity for Budoprutug in Immune Thrombocytopenia at EHA Congress 2026 (GlobeNewswire) - "Enrollment ongoing in the high dose cohort, with additional data anticipated by year-end 2026...As of June 1, 2026, 15 patients had been enrolled across the 250 mg (n=6) and 500 mg (n=9) dose cohorts, median follow-up was 38 weeks and 12 weeks for the 250 mg and 500 mg cohorts respectively...In the 250 mg dose cohort, B-cell levels were depleted by an average of over 90% by Week 4 and mean platelet count increased by 111,000 platelets/µL at Week 24; Durable platelet responses were achieved in four out of six patients in the 250 mg dose cohort, with two out of six patients experiencing platelet levels >100 x 103/µL for over 24 weeks; Of the four patients who had previously been treated with rituximab, three responded to treatment with budoprutug, two with durable and complete responses; Results to date support continued clinical evaluation of budoprutug in ITP; enrollment in the 1000 mg cohort is ongoing."

P1 data • Immune Thrombocytopenic Purpura

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

Climb Bio to Present New Budoprutug Clinical Data at European Hematology Association (EHA) 2026 Congress (GlobeNewswire) - "Climb Bio will present data, including safety, B-cell depletion and initial platelet data from the low dose cohort (250mg at 24 weeks), from the ongoing Phase 1b/2a trial of budoprutug, a novel anti-CD19 monoclonal antibody, in previously treated patients with primary immune thrombocytopenia (ITP)."

P1/2 data • Immune Thrombocytopenic Purpura

Climb Bio Hosts Budoprutug R&D Spotlight Event Highlighting Topline Subcutaneous Formulation Data, Broad B-Cell Mediated Disease Opportunity, and Upcoming Data Readouts (GlobeNewswire) - "ITP Phase 1b/2a study – Initial B-cell and platelet data from low dose cohort (250 mg at 24 weeks) expected in June; additional data from higher dose cohorts by year-end; pMN Phase 2 study – Initial B-cell and anti-PLA2R data from the low dose cohort (200 mg at 12-24 weeks) expected in Q4; SLE Phase 1b global study – Initial B-cell data expected in Q4."

P1 data • P1/2 data • P2 data • Immune Thrombocytopenic Purpura • Nephrology • Systemic Lupus Erythematosus

A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Climb Bio, Inc.

New P1/2 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Climb Bio to Host R&D Spotlight Webcast Highlighting Budoprutug and the CD19 Opportunity on May 5, 2026 (GlobeNewswire) - "The event will highlight the Company’s budoprutug program, a clinical-stage, anti-CD19 monoclonal antibody with the potential to address a broad range of B-cell mediated, immune-driven diseases....The budoprutug event will feature: An overview of CD19 as a target for B-cell mediated disease; Scientific rationale and potential commercial opportunity for budoprutug in pMN, ITP, and SLE; Design of ongoing studies and dose selection; Details on the Company’s development strategy for budoprutug."

Clinical • Clinical protocol • Trial status • Immune Thrombocytopenic Purpura • Renal Disease • Systemic Lupus Erythematosus

Climb Bio Announces FDA Fast Track Designation for Budoprutug for the Treatment of Primary Membranous Nephropathy (GlobeNewswire) - "Global Phase 2 open-label clinical trial in pMN (PrisMN) enrolling, with initial data anticipated H2 2026"

Fast track • P2 data • Nephrology

A Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers (clinicaltrials.gov) - P1 | N=38 | Active, not recruiting | Sponsor: Climb Bio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

TNT119-ITP-201: A study to find how well budoprutug (TNT119) works and how safe it is in participants with immune thrombocytopenia (clinicaltrialsregister.eu) - P1/2 | N=13 | Recruiting | Sponsor: Climb Bio Inc.

New P1/2 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

TNT119-SLE-101: A study to find how well budoprutug (TNT119) works and how safe it is in participants with Systemic Lupus Erythematosus (clinicaltrialsregister.eu) - P1 | N=11 | Recruiting | Sponsor: Climb Bio Inc.

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy (clinicaltrials.gov) - P1/2 | N=6 | Terminated | Sponsor: Tenet Medicines | Active, not recruiting ➔ Terminated; Sponsor change

Trial termination • Glomerulonephritis • Renal Disease

Initiated Phase 1b/2a Trial in Immune Thrombocytopenia (ITP) (GlobeNewswire) - "Dosing is ongoing in the open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in relapsed/refractory ITP designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion and platelet counts."

Trial status • Immune Thrombocytopenic Purpura

Budoprutug anti-CD19 monoclonal antibody (GlobeNewswire) - "Dosing is ongoing in the global, open-label, dose-escalation Phase 1b trial of a single dose of budoprutug in moderate to severe SLE to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B-cell depletion, autoantibody levels, and clinical activity. In December 2025, the Company received clearance of its investigational new drug application (IND) in China to initiate a separate, parallel China Phase 1b trial in SLE, which will complement our ongoing study and also seek to enroll SLE patients who have lupus nephritis...China SLE Phase 1b: first patient dosed (H1 2026)....SLE Phase 1b: initial data, including preliminary efficacy (H2 2026)."

New P1 trial • P1 data • Trial status • Lupus Nephritis • Systemic Lupus Erythematosus

2026 Anticipated Milestones (GlobeNewswire) - "PrisMN (pMN) Phase 2: initial data (H2 2026); ITP Phase 1b/2a: initial data, including preliminary efficacy (H2 2026)."

P1/2 data • P2 data • Immune Thrombocytopenic Purpura • Immunology

A Phase 1b/ 2a study of budoprutug in patients with immune thrombocytopenia (ITP) (ASH 2025) - P1/2 | "Second-line options include either a recombinant humanthrombopoietin receptor agonist (TPO-RA) or B-cell depletion using an anti-CD20 monoclonal antibody(mAb; rituximab). This Phase 1b/2a study will provide initial evidence regarding the safety and efficacy ofCD19-targeted B-cell depletion with multiple doses of budoprutug in patients with ITP."

Clinical • Glomerulonephritis • Hematological Disorders • Immune Thrombocytopenic Purpura • Rare Diseases • Renal Disease • Thrombocytopenia • Thrombocytopenic Purpura • RAS

Long-Term Remission of Proteinuria in Primary Membranous Nephropathy After Four Doses of Budoprutug, a Novel Anti-CD19 Monoclonal Antibody (KIDNEY WEEK 2025) - P1/2 | "Patient 2 achieved serologic remission and PR (UPCR 0.33 g/g) during the study, relapsed ~1 year post-treatment, and received two doses of rituximab 1,000 mg. Conclusion In four patients with PMN we followed long-term at our clinics, prior study treatment with four doses of the novel anti-CD19 mAb budoprutug led to long-term control of proteinuria for up to 3 years, 3/4 received no additional immunosuppressive treatment and no clinically significant treatment-related AEs were observed. These findings support further investigation of budoprutug as a potential disease-modifying therapy for PMN."

Clinical • Glomerulonephritis • Immunology • Renal Disease

Budoprutug Program Updates and Anticipated Milestones (GlobeNewswire) - "Anticipate initial ITP data, including preliminary efficacy, in H2 2026...Anticipate initial SLE data, including preliminary efficacy, in H2 2026."

P1 data • P1/2 data • Immune Thrombocytopenic Purpura • Immunology • Systemic Lupus Erythematosus

PrisMN: A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Climb Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • Renal Disease