ValenzaBio Announces FDA Clearance of Investigational New Drug Application for VB421, an Anti-IGF-1R Monoclonal Antibody for the Treatment of Thyroid Eye Disease

Company plans to initiate single ascending dose, first-in-human study imminently

Early single dose cohorts to include subcutaneous formulation

Topline results from the Phase 1a expected in Q3 2022

BETHESDA, Md.--(BUSINESS WIRE)--ValenzaBio, Inc., a biopharmaceutical company developing monoclonal antibody (mAb) therapeutics for autoimmune and inflammatory indications, today announced that its investigational new drug (IND) application for its lead drug candidate, VB421, for the treatment of thyroid eye disease (TED), has been cleared by the U.S. Food and Drug Administration (FDA) for clinical evaluation. VB421 is a potential best-in-class mAb targeting IGF-1R, which plays a central role in the pathogenesis of TED.

VB421 binds to IGF-1R with sub-50 pM potency and possesses favorable biophysical properties that may provide a differentiated product profile relative to other anti-IGF-1R antibodies. These advantages may enable a patient-friendly, rapid, and small-volume subcutaneous injection that could expand settings of care for TED patients. The Company will begin enrollment in a Phase 1a trial of VB421 in the second quarter of 2022 to evaluate various dose levels administered via subcutaneous injection or intravenous infusion to healthy volunteers. Based on findings from this study, the Company plans to initiate a Phase 1b study to evaluate multiple ascending doses of the low-volume, subcutaneous formulation in patients with TED before year end.

“We are excited to have received FDA clearance of our IND application for VB421, enabling us to move a second program from our pipeline of differentiated mAbs into clinical development,” said Dr. Greg Keenan, M.D., chief medical officer of ValenzaBio. “From our extensive discussions with key-opinion leaders and other stakeholders, we know that an easy to administer, subcutaneous therapy would be a welcome treatment option for this devastating disease that leads to significant morbidity, including proptosis (eye bulging), diplopia (double vision), eye pain and potentially blindness. Our Phase 1a study will provide critical PK, PD and biomarker data that will inform dose selection and development plans for our future trials in TED patients.”

About ValenzaBio, Inc.

ValenzaBio is a privately held biopharmaceutical company developing safe and effective therapies for autoimmune and inflammatory diseases. The company is advancing a pipeline of differentiated monoclonal antibodies with best-in-class properties, targeting clinically validated mechanisms of action, to provide improved treatment options for patients. In addition to VB421, ValenzaBio's first program in clinic, VB119, continues to actively enroll trials in renal autoimmune indications. A third program, VB517 is expected to begin clinical trials in 2023. ValenzaBio is based in Bethesda, MD.

For more information, please visit www.valenzabiotech.com.