Vincerx Pharma Presents Positive Preliminary Phase 1 Data for VIP236 and Updates on Pipeline Progress at the American Association for Cancer Research (AACR) Annual Meeting 2024 - Seite 2

Vivek Subbiah, M.D., Chief of Early-Phase Drug Development at Sarah Cannon Research Institute commented, "In the oncology landscape, ADCs have emerged as a new and encouraging treatment option for people facing cancer. With a decade of invaluable insights in ADC drug development, we are transitioning from first to second to third generations, and the imperative now is for novel mechanisms of action. Innovations like VIP236's optimized camptothecin, which can potentially circumvent some of the known camptothecin liabilities and issues with drug resistance, deliver a potent payload from a clinically validated drug class. The goal is to deliver best-in-class therapies to meet the urgent needs of patients battling advanced cancers.”

VIP236 Updates

• Study VNC-236-101 is an open-label, multicenter, Phase 1 dose-escalation study with monotherapy VIP236 for the treatment of patients with metastatic tumors who have exhausted all standard therapy options. The study's main objective is to determine a safe dose and schedule for VIP236 for further clinical development.
• Fifteen patients have been dosed to date on the once every three weeks (Q3W) schedule. Sequential dose-escalation cohorts with the Q3W schedule were 0.2 mg/kg (n=2), 0.4 mg/kg (n=5), 0.6 mg/kg (n=5), and 0.8 mg/kg (n=3). Results of the Q3W schedule (n=15) show:
  • The patient population is typical of a Phase 1 study with heavily pretreated patients and a wide range of tumor types.
  • The Q3W schedule is well tolerated with no dose-limiting toxicity (DLT) in any patients, and no patients have discontinued VIP236 due to an adverse event. Importantly, no severe or life-threatening diarrhea has been observed, validating the purposeful design of VIP236’s optimized camptothecin payload.
  • First efficacy assessment was at the end of cycle 2 (i.e. after only two doses on the Q3W schedule). Seven patients have achieved objective stable disease, including tumor reduction. Four patients remain on study with the longest treated patient on study for 168 days.
• Dose escalation continues on the Q3W schedule. Vincerx anticipates presenting additional Phase 1 data for VIP236 later this summer.

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