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Vincerx Pharma Granted FDA IND Clearance for VIP943

Wednesday, August 23, 2023

Vincerx Pharma, Inc. (Nasdaq: VINC), a company dedicated to pioneering advancements in cancer therapeutics, has announced that it has secured clearance from the U.S. Food and Drug Administration (FDA) to proceed with its Investigational New Drug (IND) application for VIP943. This milestone allows the company to initiate a Phase 1 clinical trial for VIP943, with the enrollment of the first patient anticipated in the early fourth quarter of 2023.

Dr. Ahmed Hamdy, CEO of Vincerx, emphasized the significance of this accomplishment, stating, "The FDA's IND clearance represents a pivotal stride for the VIP943 development initiative, marking our first candidate from our antibody-drug conjugate (ADC) platform to advance into clinical trials." Dr. Hamdy continued, "VIP943, built upon our innovative platform, aims to amplify efficacy and tackle safety concerns often associated with ADCs. This pioneering platform integrates an internalizing antibody binding to CD123, a novel KSPi payload, a discerning and stable linker, and our exclusive CellTrapper™ technology. We possess a strong belief in VIP943's potential to offer a crucial treatment avenue for patients grappling with acute myeloid leukemia (AML). Our enthusiasm to kickstart the clinical program underscores our commitment to realizing the therapeutic possibilities of this compound."

Dr. Hamdy also highlighted Vincerx's accomplishments, sharing, "The ongoing year, 2023, is shaping up to be exceptionally positive for Vincerx. Over the past eight months, we have successfully submitted two INDs (VIP236 and VIP943) and promptly obtained FDA clearance for both within a span of just 30 days. These achievements underscore the robustness of our development, drug manufacturing, and regulatory expertise. Looking ahead, along with commencing the Phase 1 trial for VIP943, we anticipate delivering preliminary outcomes for VIP236, expected in late 2023 or early 2024. These collective milestones underscore the potential of our strategy in advancing small molecule and antibody-based conjugate therapies, thereby enhancing care for cancer patients."

VIP943 is an innovative ADC developed using Vincerx's advanced ADC technology, designed to heighten intracellular accumulation of the KSPi payload (kinesin spindle protein inhibitor), potentially leading to increased efficacy while mitigating undesired side effects. The compound binds to CD123, a validated target in myeloid malignancies, and upon entering the cell, releases its KSPi payload. Vincerx's CellTrapper™ technology ensures targeted accumulation of the KSPi payload within the designated cells, limiting uptake by non-dividing, non-targeted cells.

Preclinical studies have demonstrated VIP943's prolonged survival and decreased tumor burden in AML (acute myelogenous leukemia) cell lines and patient-derived tumor models. Moreover, Vincerx presented preclinical data on VIP943 at ASH 2022, highlighting its superiority over Mylotarg™, an approved ADC. VIP943 exhibited significantly improved safety in monkeys and superior efficacy in a mouse model of acute leukemia. Notably, preclinical data suggests that VIP943 induces minimal cytokine release, showcasing favorable safety in monkeys, alongside an optimal drug metabolism and pharmacokinetics profile.The Phase 1 trial of VIP943 aims to evaluate the compound's safety, pharmacokinetics/pharmacodynamics, and preliminary efficacy in patients with advanced AML and myelodysplastic syndrome (MDS).

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