Vincerx Pharma announces FDA clearance of IND for VIP943

Vincerx Pharma reported that it has received clearance for its Investigational New Drug, IND, application from the U.S. Food and Drug Administration, FDA, to initiate a Phase 1 clinical trial for VIP943. Vincerx expects to enroll the first patient in the study early in the fourth quarter of 2023. “The IND clearance by the FDA is a significant step forward for the VIP943 development program, our first candidate from our antibody-drug conjugate platform to enter clinical trials,” said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. “Our next-generation platform is designed to improve efficacy and address safety challenges associated with many ADCs. It combines an internalizing antibody binding to CD123, a novel KSPi payload, a selective and stable linker, and exclusive CellTrapper technology. We believe VIP943 has the potential to become a much needed treatment option for patients with acute myeloid leukemia. We’re eager to start the clinical program and unlock the potential therapeutic benefits of this compound.”