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

Anticipated Milestones (GlobeNewswire) - "Budoprutug (anti-CD19 monoclonal antibody): pMN Phase 2 study – first patient in (H2 2025); Company to provide guidance on the anticipated timing of clinical readouts in SLE and ITP (H2 2025)."

Clinical data • Immune Thrombocytopenic Purpura • Nephrology • Systemic Lupus Erythematosus

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

New P1 trial

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

New P2 trial • Glomerulonephritis • Renal Disease

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

Enrollment open

A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Climb Bio, Inc.

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

A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Climb Bio, Inc.

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

Portfolio Overview and Anticipated Key Milestones (GlobeNewswire) - "A Phase 1b trial of budoprutug in pMN has been completed and the Company has received clearance from the FDA to initiate a Phase 2 clinical trial. The Company anticipates dosing its first patient in this study in the second half of 2025; The Company now has clearance from the FDA to initiate a Phase 1b/2a clinical trial of budoprutug in ITP and anticipates dosing its first patient in the first half of 2025; the Company remains on track to initiate a Phase 1b clinical study of budoprutug for SLE and anticipates dosing its first patient in the first half of 2025; The Company plans to share additional non-clinical data for the subcutaneous program in the first half of 2025 and plans to progress the subcutaneous program into clinical development in the second half of 2025."

New trial • Preclinical • Renal Disease • Systemic Lupus Erythematosus • Thrombocytopenia

A Phase 1b, Single-Arm, Open-Label Study of Budoprutug, an Anti-CD19 Monoclonal Antibody with Enhanced Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC), in Primary Membranous Nephropathy (KIDNEY WEEK 2024) - "Treatment with budoprutug resulted in high rates of serologic and clinical remission, suggesting that CD19-targeted B-cell depletion may be a promising approach to the treatment of primary MN. These findings warrant larger studies to confirm the efficacy of budoprutug in MN."

Clinical • P1 data • Glomerulonephritis • Renal Disease

Phase 1b/2a in SLE With Budoputug (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Tenet Medicines | N=40 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Phase 1b/2a in SLE With Budoputug (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: Tenet Medicines

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

Eliem Therapeutics Announces the Closing of its Acquisition of Tenet Medicines and Concurrent $120 Million Private Placement (GlobeNewswire) - "Eliem Therapeutics...today announced the closing of its acquisition with Tenet Medicines ('Tenet'). The transaction closed on June 27, 2024. Following the closing, Eliem will focus on developing therapeutics for autoimmune-driven inflammatory diseases, including advancing TNT119, an anti-CD19 antibody designed for a broad range of autoimmune diseases, including systemic lupus erythematosus, immune thrombocytopenia and membranous nephropathy....'With the concurrent close of our $120 million private placement, we now have a robust balance sheet with approximately $220 million in cash and cash equivalents and are poised to advance the development of TNT119, our lead anti-CD19 antibody, through multiple milestones and for several autoimmune diseases. We look forward to initiating Phase 2 clinical trials of TNT119 later this year.'"

M&A • New P2 trial • Immunology • Systemic Lupus Erythematosus • Thrombocytopenia

Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Tenet Medicines | Trial completion date: Aug 2024 ➔ Oct 2023 | Active, not recruiting ➔ Terminated; Sponsor change

Trial completion date • Trial termination • CNS Disorders • Focal Segmental Glomerulosclerosis • Glomerulonephritis

Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - P2 | N=1 | Active, not recruiting | Sponsor: Tenet Medicines | N=20 ➔ 1 | Trial completion date: Nov 2023 ➔ Aug 2024

Enrollment change • Trial completion date • CNS Disorders • Focal Segmental Glomerulosclerosis • Glomerulonephritis

Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy (clinicaltrials.gov) - P1/2 | N=6 | Active, not recruiting | Sponsor: Tenet Medicines | Recruiting ➔ Active, not recruiting | Phase classification: P1b/2a ➔ P1/2 | N=30 ➔ 6 | Trial completion date: Oct 2023 ➔ Aug 2024

Enrollment change • Enrollment closed • Phase classification • Trial completion date • Glomerulonephritis • Renal Disease

Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: ValenzaBio, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2024 ➔ Nov 2023 | Trial primary completion date: Nov 2023 ➔ Jun 2023

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Focal Segmental Glomerulosclerosis • Glomerulonephritis

A Phase 1b/2a Single Arm Open-Label Study of VB119, an Anti-CD 19 Monoclonal Antibody (Mab), in Active Primary Membranous Nephropathy (PMN): An Interim Report (KIDNEY WEEK 2022) - "All participants receiving VB119 and having observations ≥6 weeks through September 15, 2022 will be reported. Proteinuria, PLA2R and Total B-cell change over time"

Clinical • P1/2 data • Glomerulonephritis • Immunology • Renal Disease • CD19

Efficacy and Safety of VB119 in Subjects With Minimal Change Disease and Focal Segmental Glomerulosclerosis (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: ValenzaBio, Inc.

New P2 trial • CNS Disorders • Focal Segmental Glomerulosclerosis • Glomerulonephritis