Developing differentiated treatment options

For Patients with Autoimmune & Inflammatory Diseases

About Us

ValenzaBio is a privately-held biopharmaceutical company developing therapies for autoimmune and inflammatory diseases. With a pipeline of differentiated monoclonal antibodies targeting clinically-validated mechanisms of action, we seek to provide improved therapies for patients with limited treatment options. Based in Bethesda, Maryland, in the heart of the capital biotech community, we strive to work collaboratively with all stakeholders while keeping our research and development efforts focused on the needs of patients.

ValenzaBio implements biomarker-driven approaches to guide research and clinical development

Our pipeline includes monoclonal antibodies that target cell surface receptors. Upon binding, our medicines can reduce the activation of pathogenic responses in autoimmune and inflammatory conditions.

Pipeline

VB119

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.

Learn more about Membranous Nephropathy Learn more about our clinical trial in Membranous Nephropathy ClinicalTrials.gov ID: NCT04652570

VB421

Program Overview

VB421 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, VB421 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 VB421 has the potential to be a best-in-class therapeutic for TED. VB421 is currently in an IND-enabling program to support first-in-human studies for the treatment of TED and other autoimmune and fibrotic diseases.

Learn more about Thyroid Eye Disease

Management Team

Patrick J. Crutcher, MSc

President Executive Chairman Co-Founder

Stephen Thomas, PhD

Chief Scientific Officer

Gregory Keenan, MD

Chief Medical Officer

Tatyana Touzova, MSc

Chief Operating Officer

William Bonificio, PhD

Chief Strategy Officer

Jay Mitchell, MBA

Vice President Clinical Operations

David Maizenberg, JD

General Counsel Board Member Co-Founder

Board of Directors

Patrick J. Crutcher, MSc

David Maizenberg, JD

Mike Solomon, PhD

John Doux, MD

Scientific Advisory Board

Raymond Douglas, MD, PhD

Jamie Dwyer, MD

Stephen Thomas, PhD

Greg Keenan, MD

Contact

6701 Democracy Blvd Suite 300
Bethesda, Maryland 20817

Contact

6701 Democracy Blvd Suite 300
Bethesda, Maryland 20817