By Robb M. Stewart

Genprex Inc.'s shares climbed early Monday after it received a second fast track designation from the Food and Drug Administration for its lead drug candidate.

In premarket trading, the stock was 8.4% higher after closing last week at $1.31, down 68% over the last 12 months.

Genprex said the FDA granted fast track designation to its Reqorsa immunogene therapy, in combination with Merck & Co.'s Keytruda, in patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer whose disease progressed after treatment with Keytruda.

The company said it expects to begin its Acclaim-2 clinical trial in the first quarter of 2022. The trial is an open-label, multi-center Phase 1/2 clinical trial evaluating Reqorsa in combination with Keytruda.

Genprex received its first fast track designation for Reqorsa in combination with AstraZeneca PLC's Tagrisso in patients with histologically confirmed unresectable stage III or IV NSCLC, with EGFR mutations that progressed after treatment with Tagrisso.

The FDA may give fast track designation to drug candidates it determines that via non-clinical or clinical data demonstrate the potential to address unmet medical need for a serious or life-threatening disease or condition. Companies that receive fast track designation may be for accelerated approval or rolling review of a biologics license application, if other qualifying criteria are met. Fast track product candidates also could be eligible for priority review if supported by clinical data at the time of biologics license application submission.

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

(END) Dow Jones Newswires

01-03-22 0844ET