For Patients with Autoimmune & Inflammatory Diseases

Program Overview

VB119 is an IgG1 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and potent binding to CD19, a B-cell surface receptor found on autoantibody-secreting cells (ASCs). ASCs are closely linked to several autoimmune diseases, including membranous nephropathy (MN). Pathogenic ASCs often lack expression of CD20 and are not targeted by anti-CD20 antibodies, such as rituximab. Proof-of-mechanism for VB119 was established in a completed Phase 1 clinical trial, where peripheral B-cell depletion was observed in most patients after a single dose of VB119. VB119’s ability to bind and eliminate disease-causing ASCs that are not directly targeted by conventional therapies has the potential to provide clinical benefit for patients with MN, as well as other autoantibody-mediated diseases.

ValenzaBio is initiating an open-label Phase 1b/2a clinical trial of VB119 in primary MN patients with nephrotic-range proteinuria. This trial is a multi-center, open-label study to evaluate the safety, PK and efficacy of VB119. Key assessments include serum anti-PLA2R antibodies and proteinuria. If you are an MN patient or clinical investigator in the US or UK and are interested in learning more about our study, please click here for more information.

Program Overview

Lonigutamab binds IGF-1R with sub-50 pM potency and no measurable effector function. IGF-1R signaling is implicated in several inflammatory and fibrotic diseases. In addition to high binding affinity, lonigutamab induces rapid and efficient receptor internalization that could potentially provide a differentiated mechanism-of-action relative to other anti-IGF-1R antibodies. IGF-1R overexpression and activation within orbital fibroblasts is thought to play a central role in the pathogenesis of Thyroid Eye Disease (TED). ValenzaBio believes lonigutamab has the potential to be a best-in-class therapeutic for TED. Lonigutamab is currently in an IND-enabling program to support first-in-human studies for the treatment of TED and other autoimmune and fibrotic diseases.

Program Overview

VB517 is a fully human mAb with low-picomolar affinity for c-KIT, a receptor tyrosine kinase critical to the survival and activation of mast cells (MCs). Blocking c-KIT has been shown to reduce mast cell degranulation and induce mast cell depletion in clinical studies. VB517 has demonstrated potent suppression of human mast cell activation in preclinical models. Given its unique binding and pharmacological properties, ValenzaBio believes VB517 has the potential to be a best-in-class treatment for mast cell-driven diseases, including chronic urticaria. ValenzaBio plans to initiate clinical studies of VB517 in 2023.