Vincerx Shares Positive Early Results from VIP943 Phase 1 Study and Provides Updates

Vincerx Pharma, Inc., a biopharmaceutical company dedicated to innovative cancer treatments, has announced promising results for its antibody-drug conjugate (ADC), VIP943. In an ongoing Phase 1 dose-escalation study, VIP943 has demonstrated significant efficacy in patients with relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and B-cell acute lymphoblastic leukemia (B-ALL). The study, which aims to evaluate the safety and effectiveness of VIP943, has shown two complete responses among the participating hard-to-treat patients.

To date, the Phase 1 study has enrolled 22 patients across various dose levels ranging from 0.2 to 1.3 mg/kg once weekly. The patient cohort is particularly challenging to treat, with nine individuals having received at least three doses of the drug at efficacious levels (≥1.0 mg/kg). Of these nine patients, four remain in the study, with one experiencing complete remission with incomplete hematologic improvement (CRi) and another achieving complete remission with limited count recovery (CRL). These results highlight the potential of VIP943 as a promising treatment option for CD123+ hematologic malignancies.

Vincerx CEO Dr. Ahmed Hamdy expressed enthusiasm about the emerging data, emphasizing that the clinical responses validate the company's VersAptx platform, designed to create safe and effective bioconjugates. As of August 2024, no dose-limiting toxicities have been reported among the 22 patients. The most common serious adverse events (SAEs) included pneumonia (14%) and cellulitis and febrile neutropenia (9% each), with only one patient experiencing a drug-related SAE.

Pharmacodynamic data has demonstrated that VIP943 effectively binds to CD123+ peripheral blood blasts from AML patients, achieving maximal receptor occupancy of 84% at the highest dose cohort. The pharmacokinetic profile of VIP943 shows a half-life of less than 96 hours, with minimal payload release and no accumulation on repeat dosing. These findings have led to the ongoing evaluation of a twice-weekly dosing regimen for potential induction therapy.

In addition to VIP943, Vincerx has provided updates on other assets in its pipeline. VIP236, a small molecule-drug conjugate, is being evaluated in a Phase 1 study for advanced solid tumors. As of September 2024, 29 patients have been enrolled, with a disease control rate of 45% among the 20 evaluable patients. VIP236 has shown a favorable safety profile, with no dose-limiting toxicities commonly associated with camptothecins, demonstrating its potential as a combination agent for advanced cancer treatments.

The company is also progressing with enitociclib, a highly selective CDK9 inhibitor, in a Phase 1 study in combination with venetoclax and prednisone for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL) in collaboration with the National Institutes of Health (NIH). The study has reported four partial responses among seven patients, indicating a 57% overall response rate, including responses from patients with double-hit lymphoma and those previously treated with CAR-T therapy.

Vincerx plans to streamline its operations by transitioning VIP236 to a partnering asset, allowing the company to concentrate on the continued development of VIP943. This strategic focus aims to maximize the potential of VIP943 and the VersAptx platform, which offers a versatile approach to developing bioconjugates tailored to address different cancer biologies.

Vincerx Pharma remains committed to advancing its diverse pipeline, which includes the next-generation ADC VIP943, the small molecule-drug conjugate VIP236, the preclinical ADC VIP924, and the CDK9 inhibitor enitociclib. With a seasoned management team and a robust clinical-stage portfolio, Vincerx is poised to make significant contributions to cancer therapeutics.