VTX-0811 / 3SBio, Verseau Therap - LARVOL DELTA

Preclinical Efficacy of VTX-0811: A Humanized First-in-Class PSGL-1 mAb Targeting TAMs to Suppress Tumor Growth. (PubMed, Cancers (Basel)) - "A chimeric version of VTX-0811, consisting of the parental murine antibody in a human IgG4 backbone, inhibits tumor growth in a humanized mouse model of cancer. VTX-0811 is exceptionally well tolerated in NHP toxicology assessment and is heading into clinical evaluation after successful IND clearance."

Journal • Preclinical • Oncology

VTX-0811, a first-in-class PSGL-1 blocking monoclonal antibody, repolarizes tumor associated macrophages and induces inflammation in the tumor microenvironment, leading to suppression of tumor growth in pre-clinical studies (AACR 2022) - "VTX-0811 does not induce activation of unstimulated PBMC or unstimulated blood-derived neutrophil or T cell cultures. These data provide biological and mechanistic support for advancing this program into the clinic with a first in human trial planned for early 2022."

Preclinical • Tumor microenvironment • Melanoma • Oncology • Solid Tumor • CD8 • TNFA

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