ValenzaBio, Inc., a biopharmaceutical company developing monoclonal antibody therapeutics for autoimmune and inflammatory indications, announced the completion of a $70 million Series A financing from premier investors Fidelity Management & Research Company, LLC, and Surveyor Capital (a Citadel company), with additional participation by founding investors Ikarian Capital, LLC, Janus Henderson Investors and Opaleye Management, Inc. Pierre Fabre Medicament will also take an equity stake in the company as part of a recently executed license and commercialization agreement. The fundraise will support the advancement and expansion of ValenzaBio’s pipeline toward clinical development, including:

• VB119, an anti-CD19 monoclonal antibody being developed for the treatment of membranous nephropathy (MN), and other autoantibody-mediated diseases, where the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application; and

• VB421, a potential best-in-class anti-IGF-1R antibody, which ValenzaBio has licensed from Pierre Fabre and plans to evaluate for the treatment of thyroid eye disease (TED) and other inflammatory disorders.

“Since our founding, we have been focused on building a pipeline of differentiated monoclonal antibodies targeting clinically-validated mechanisms of action, and for which biomarker-driven approaches can enable rapid development strategies,” said Patrick Crutcher, president and chief executive officer of ValenzaBio. “We have attracted an exceptional team of drug discoverers and developers, that when combined with our pipeline and the capital raised from this leading group of investors, positions us well to ultimately bring new and improved therapies to patients with limited or no treatment options.”

“The IND acceptance of VB119 is an important milestone for ValenzaBio, and we look forward to dosing our first MN patient in the second quarter of 2021. MN can lead to disabling and, in some cases, life-threatening complications for patients; and given the lack of any FDA-approved therapies today, VB119 has an opportunity to impact the lives of patients with this rare disease,” said Stephen Thomas, Ph.D., chief scientific officer of ValenzaBio. “Further, the addition of VB421 to our pipeline may enable us to provide a new therapeutic option for patients with TED, a debilitating and painful autoimmune disease that causes eye bulging and risk of vision loss. With a formidable preclinical package in hand through our agreement with Pierre Fabre, we are prepared to move quickly into an IND-enabling program.”

VB119 for MN

VB119 is an IgG1 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity 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 MN. Proof-of-mechanism for VB119 was previously established in a Phase 1 clinical trial completed by Cancer Research UK, where peripheral B-cell depletion was observed in 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. Following the recent IND acceptance, ValenzaBio is initiating an open-label Phase 1b/2a trial to assess the safety and tolerability of multiple doses of VB119 in patients with MN. The Company also plans to file a Clinical Trial Application in the UK in the second quarter of 2021.

VB421 for TED

ValenzaBio has entered into a license and commercialization agreement with Pierre Fabre for a monoclonal antibody directed to insulin-like growth factor 1 receptor (IGF-1R), which ValenzaBio plans to progress into the clinic in the first half of 2022. Designated VB421, the antibody is designed to potently bind IGF-1R, which when overexpressed or activated within orbital fibroblasts, is believed to play a central role in the pathogenesis of TED. VB421 binds IGF-1R with sub-50 pM potency and could potentially provide a differentiated product profile relative to other anti-IGF-1R antibodies.

Under the terms of the agreement, ValenzaBio receives exclusive worldwide development rights outside of oncology, as well as associated preclinical data. Pierre Fabre retains opt-in rights to develop VB421 outside North America following proof-of-concept data in patients. If Pierre Fabre exercises this option, the companies will proceed as partners in global development. Financial details of the agreement are undisclosed.

“Pierre Fabre's expertise in monoclonal antibody and on the IGF-1 biology led us to develop a compound with picomolar binding affinity and unique internalization properties. Based on these properties, this monoclonal antibody has the potential to be the best-in-class product for the treatment of TED. ValenzaBio has demonstrated an ability to apply thoughtful clinical and regulatory strategies to take oncology drugs into autoimmune and inflammatory settings. We are now delighted to work with the highly motivated team at ValenzaBio to bring this antibody to autoimmune patients with medical needs,” said Nathalie Corva?a, Head of Immuno-Oncology Research at Pierre Fabre.