The US Food and Drug Administration (FDA) has approved Vincerx Pharma’s investigational new drug (IND) application, enabling initiation of a Phase I clinical trial of VIP943 for the treatment of acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS).
The study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy of VIP943.
Vincerx anticipates enrolling the first patient in the fourth quarter of this year.
Vincerx Pharma CEO Dr Ahmed Hamdy said: “The IND clearance by the FDA is a significant step forward for the VIP943 development programme, our first candidate from our antibody-drug conjugate (ADC) platform to enter clinical trials.
“Our next-generation platform is designed to improve efficacy and address safety challenges associated with many ADCs.
“It combines an internalising antibody binding to CD123, a novel kinesin spindle protein inhibitor (KSPi) payload, a selective and stable linker, and exclusive CellTrapper technology.”
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Earlier studies of VIP943 have been shown to increase survival and reduce the tumour burden in AML cell lines and patient-derived tumour models.
Hamdy added: “Within the last eight months, we successfully filed two INDs (VIP236 and VIP943) and swiftly garnered clearance from the FDA within 30 days.
“Looking ahead, in addition to beginning our Phase I trial for VIP943, we also expect to provide preliminary results for VIP236 by late 2023 or early 2024.”