Vincerx Pharma Doses First Patient in the Phase 1 Clinical Trial Evaluating VIP943 - Seite 2

Howard A. “Skip” Burris, III, M.D., President of SCRI and Scientific Advisory Board member for Vincerx, said, “There is growing hope for delivering targeted therapies through the use of ADCs. Targeting hematologic malignancies with an ADC that combines selective binding to CD123 and a potentially improved safety profile, compared to other ADCs and CD123-targeting therapies, could provide a much needed treatment option for patients. Our team is excited to collaborate with Vincerx and begin enrolling patients in this Phase 1 dose escalation study.”

About VIP943

VIP943 is the lead program from our next-generation ADC platform. VIP943 binds to CD123, a validated target in myeloid malignancies. Once inside the cell, it is only cleaved by an intracellular protein called legumain, allowing specific release and activation of the KSPi payload within the cancer cell. KSPi provides a novel way to deliver a cell cycle arrest agent, leading to cell death, which is a clinically validated ADC payload class mechanism. Vincerx’s novel legumain-specific linker substantially reduces non-specific release of the payload, thereby reducing unwanted side effects on healthy cells. In addition, Vincerx’s CellTrapper technology ensures that the KSPi payload accumulates in the target cells, limiting uptake into non-target, non-dividing cells. The innovative and intentional combination of a validated CD123 antibody, an intracellular cleavable legumain linker, and a potent KSPi payload holds the potential to address prevalent challenges of many ADCs by increasing the therapeutic window, thus improving efficacy and reducing common, severe toxicities such as myelosuppression, infections, peripheral neuropathy, and hepatotoxicity.

VIP943 has demonstrated increased survival and reduced tumor burden in AML cell lines and patient-derived tumor models. Additionally, Vincerx presented preclinical data on VIP943 at ASH 2022, demonstrating superiority versus Mylotarg, an approved ADC, with significantly improved safety in monkeys and better efficacy in a mouse model of acute leukemia. Preclinical data suggest that VIP943 does not induce significant cytokine release syndrome, common to other CD123-targeting agents, and demonstrated favorable safety in monkeys, with an optimal drug metabolism and pharmacokinetics profile.