By Robb M. StewartGenprex 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. 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. 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.

Source: Wall Street Journal January 03, 2022 17:12 UTC