Vincerx Reports Positive Initial Clinical Data from Ongoing VIP943 Phase 1 Dose-Escalation Study and Provides Pipeline and Corporate Updates

Core Insights - Vincerx Pharma announced promising results from the Phase 1 dose-escalation study of VIP943, showing two complete responses in patients with relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and B-cell acute lymphoblastic leukemia (B-ALL) [1][2] - The company is focusing resources on the continued development of VIP943, with an expected cash runway into early 2025 [1][3] VIP943 Data Highlights - The ongoing Phase 1 study has enrolled 22 patients, with 9 patients receiving at least three doses of VIP943 at an efficacious dose of ≥1.0 mg/kg, resulting in a 44% retention rate [2] - Two patients achieved complete remission based on international consensus response criteria, underscoring the significance of these early results [2] - VIP943 demonstrated favorable safety and tolerability, with no dose-limiting toxicities reported and serious adverse events consistent with expectations for this patient population [3] Pharmacodynamics and Pharmacokinetics - Target engagement was confirmed with a maximal receptor occupancy of 84% in the highest dose cohort (1.3 mg/kg), and concurrent decreases in CD123+ peripheral blood blasts were observed [4] - Preliminary pharmacokinetic data shows low release of the payload (≤1% in plasma) and a half-life of less than 96 hours, prompting evaluation of twice weekly dosing [4][5] VIP236 Update - VIP236, a first-in-class small molecule drug conjugate, has enrolled 29 patients in its Phase 1 study, with a disease control rate of 45% among evaluable patients [7] - The drug continues to show a favorable safety profile, with no instances of common dose-limiting side effects associated with camptothecins [7] Enitociclib Update - Enitociclib, a selective CDK9 inhibitor, is being evaluated in a Phase 1 study in combination with venetoclax and prednisone, reporting a 57% overall response rate in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL) [10][11] Corporate Webcast - Vincerx will host a corporate webcast to provide updates on its pipeline, including initial clinical data from the Phase 1 study of VIP943, followed by commentary from key opinion leader Dr. M. Yair Levy [12]