VTX-1218 / Verseau Therap, 3SBio - LARVOL DELTA

Verseau Therapeutics Announces FDA Clearance of Investigational New Drug Application for VTX-0811, a PSGL-1 Monoclonal Antibody (Businesswire) - "Verseau Therapeutics, Inc...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...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...'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."

IND • New P1 trial • Oncology • Solid Tumor