Vincerx Pharma Announces FDA Clearance of IND for VIP943
Phase 1 trial expected to begin in early Q4 2023
VIP943 is Vincerx’ first candidate from next-generation ADC platform and its second IND clearance within 8 months, highlighting Vincerx’s development and regulatory expertise
"The IND clearance by the FDA is a significant step forward for the VIP943 development program, our first candidate from our antibody-drug conjugate (ADC) platform to enter clinical trials," said
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. Once inside of the cell, it releases its KSPi payload. Vincerx’s CellTrapper™ technology ensures that the KSPi payload accumulates in the target cells, limiting uptake into non-target, non-dividing cells.
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).
Vincerx is based in
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Source: Vincerx Pharma, Inc.