Vincerx Pharma Doses First Patient in the Phase 1 Clinical Trial Evaluating VIP943

Phase 1 trial enrolling patients with relapsed/refractory AML, MDS and B-cell ALL

PALO ALTO, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC)(“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported that the first patient has been dosed in the Phase 1 trial evaluating VIP943 in patients with relapsed/refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-cell ALL), NCT06034275.

"Dosing of the first patient is a major achievement for the VIP943 development program and our next-generation bioconjugation platform. This achievement occurred 17 business days from receiving our safe to proceed letter, underscoring the enthusiasm from our investigators and the strong execution capabilities of the Vincerx team," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "VIP943 is the first ADC candidate from our pioneering bioconjugation platform, designed to address the challenges of current ADCs, by increasing the therapeutic index (ie, increasing efficacy and reducing toxicity). We are the first company to bring to the clinic a legumain-cleavable linker and the first to utilize a kinesin spindle protein inhibitor (KSPi) as an ADC payload. This innovative and proprietary combination has generated strong preclinical evidence of activity and safety and has the potential to shift the treatment paradigm for patients with CD123+ hematologic malignancies. We look forward to evaluating the potential of VIP943 and expect to report preliminary safety and pharmacology data from our Phase 1 study in 2024."

Stephen A. Strickland, Jr., M.D., MSCI, Director of Leukemia Research for the Sarah Cannon Research Institute (SCRI) and Principal Investigator on the Phase 1 trial for VIP943, said, “Despite there being new medicines for hematologic malignancies such as AML, MDS and B-cell ALL, outcomes for many patients have not improved and relapse rates remain high. The urgent need for more effective treatment options persists. Several factors influence the outlook for these cancers including increased frequency in older patients and poor response rates, especially in patients who relapse after initial therapy. Vincerx’s preclinical data provides a strong rationale to support the evaluation of VIP943 in the setting of hematologic malignancies, with hopes of providing more effective and less toxic therapeutic options for patients.”