Vincerx Pharma, Inc. 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, first candidate from the antibody-drug conjugate (ADC) platform to enter clinical trials.

VIP943 is a novel ADC developed using Vincerx's next-generation ADC technology designed to enhance intracellular accumulation of the KSPi payload (kinesin spindle protein inhibitor), potentially leading to higher efficacy, while limiting unwanted side effects. VIP943 binds to CD123, a validated target in myeloid malignancies. VIP943 has demonstrated increased survival and reduced tumor burden in AML (acute myelogenous leukemia) cell lines and patient-derived tumor models.

In addition, Vincerx presented preclinical data on VIP943 at ASH 2022 demonstrating superiority against Mylotarg??, an approved ADC, with significantly improved safety in monkeys and better efficacy in a mouse model of acute leukemia. Preclinical data suggest that VIP943 does not induce significant cytokine release and demonstrated favorable safety in monkeys with an optimal drug, metabolism and pharmacokinetics profile. The Phase 1 trial of VIP943 is intended to assess safety, pharmacokinetics/phamacodynamics, and preliminary efficacy of VIP943 in patients with advanced AML and myelodysplastic syndrome (MDS).