Pharma Focus Asia

Verseau Therapeutics Announces FDA Clearance of Investigational New Drug Application for VTX-0811, a PSGL-1 Monoclonal Antibody

Wednesday, January 05, 2022

Verseau Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for its lead investigational product candidate, VTX-0811, a monoclonal antibody that binds to P-selectin glycoprotein ligand-1 (PSGL-1). VTX-0811 repolarizes macrophages, leading to coordinated anti-tumor immune responses. The FDA has completed its 30-day safety review and granted approval for the company to proceed with the proposed first-in-human clinical trial of VTX-0811.

“The clearance of our first IND is a major milestone for Verseau that brings us closer to our goal of providing a potent and broadly applicable approach for the treatment of solid tumors,” said John Edwards, Chief Executive Officer of Verseau Therapeutics. “We are incredibly excited to begin testing VTX-0811 safety and activity in patients and plan to continue this momentum with the filing of an additional IND for VTX-1218, our second macrophage repolarizer program, within the next year.”

The VTX-0811 two-part Phase 1 clinical trial will begin with an open label, dose-escalation study (Phase 1a) initially evaluating the safety profile of the drug administered intravenously (IV) to individuals with select solid tumor types that are predicted to have the highest probability of responding to treatment. This will be followed by a Phase 1b expansion portion of the trial, which will further evaluate VTX-0811 as a monotherapy and in combination with PD-1 therapy in select tumor types. The Phase 1b portion of the trial will focus on assessing anti-tumor activity of VTX-0811 in addition to safety.

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