Vincerx Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has provided a safe to proceed letter and cleared the IND application for VIP236, the Company's front-runner SMDC for the treatment of advanced solid tumors. VIP236 is a first-in-class SMDC with a tailored design to efficiently treat patients with cancer with aggressive and metastatic disease. VIP236 binds to activated (V) (3) integrin efficiently cleaved by neutrophil elastase (NE).

Both proteins are present in the tumor microenvironment (TME), are highly expressed in advanced metastatic tumors, and are associated with poor prognosis in patients with cancer. Anticancer activity occurs after a specific and targeted release of an optimized camptothecin (CPT) payload by NE in the TME. The CPT payload of VIP236 is optimized for high permeability with low active efflux potential to overcome transporter-mediated resistance observed with SN38, the active metabolite of irinotecan.

Preclinical results provide validation of targeting mechanism and demonstrate how VIP236 can deliver up to 40 times more drug to the cancer than the surrounding tissues or normal organs. This is evident in the durable tumor regressions and significant reduction of metastases in patient-derived xenograft (PDX) cancer models, including PDX models of triple negative breast cancer, renal cell carcinoma and colorectal cancer.