$Vincerx Pharma (VINC.US)$ VNC-943-101 study is an open-labe...

BAY-943 (VIP943) is the first ADC developed by Vincerx using the company's platform, consisting of an anti-CD123 antibody, a leguminous protein-based unique linker for intracellular cleavage, and a novel kinesin spindle protein inhibitor (KSPi) payload. Currently conducting a phase 1 dose escalation trial to evaluate the treatment of relapsed/refractory CD123 AML, B-ALL, or MDS patients who cannot achieve treatment requirements with standard treatment regimens.
VIP943 Data Highlights

The ongoing phase 1 dose-escalation study of VIP943 has enrolled 22 patients in several escalating dose cohorts (once weekly, 0.2 to 1.3mg/kg) to date. These 22 patients represent a salvage population considered "hard-to-treat" and have shown minimal response to monotherapy. Nine patients (6 AML; 3 HR-MDS) received at least 3 doses of effective VIP943 (i.e., ≥1.0mg/kg). Among these 9 patients, 4 (44%) are still under investigation. As of now, one relapsed AML patient achieved complete remission, incomplete hematologic recovery (CRi), and one HR-MDS patient achieved complete remission with incomplete count recovery (CRL) according to international consensus remission criteria. These remission criteria are widely considered benchmarks for approval in AML and MDS research, further underscoring the importance of these early results.
As of August 2024, VIP943 has demonstrated good safety and tolerability, with no dose-limiting toxicities reported in 22 patients. Severe adverse events (SAE) were consistent with the expected patient population. The most common SAEs included pneumonia (3 patients, 14%) and cellulitis and febrile neutropenia (each 2 patients, 9%). Only one patient (5%) experienced a drug-related SAE (Grade 3 diarrhea).