Vincerx Pharma Shares Jump 8% Premarket After FDA Clearance for Clinical Trial

By Robb M. Stewart

Vincerx Pharma's shares jumped ahead of the opening bell after the biopharmaceutical company received regulatory approval to begin an early-stage clinical trial of its VIP943 technology in patients with advanced acute myelogenous leukemia and myelodysplastic syndrome.

In premarket trading, the shares were 8.3% higher after ending Monday at 86 cents, down 16% so far this year.

Vincerx said it expects to enroll the first patient in the Phase 1 study early in the final quarter of 2023 after receiving clearance for its investigational new drug application from the U.S. Food and Drug Administration.

VIP943 is the company's first candidate from its antibody-drug conjugate platform to enter clinical trials. The antibody-drug conjugate technology is designed to enhance intracellular accumulation of the kinesin spindle protein inhibitor payload, potentially leading to higher efficacy while limiting unwanted side effects, the company said.

The Phase 1 trial of VIP943 is intended to assess safety, pharmacokinetics/phamacodynamics, and preliminary efficacy of VIP943 in patients with advanced AML and myelodysplastic syndrome.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

August 22, 2023 08:06 ET (12:06 GMT)

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