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.
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.
LONIGUTAMAB (VB421)
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.
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
News
June 18, 2021
Contact
6701 Democracy Blvd Suite 300
Bethesda, Maryland 20817
Contact
6701 Democracy Blvd Suite 300
Bethesda, Maryland 20817