By Chris Wack

Genprex Inc. shares were up 8% to $3.57 after the company said the U.S. Food and Drug Administration has reviewed and confirmed all comments have been addressed regarding the clinical trial protocol for the Phase 1/2 clinical trial evaluating Reqorsa Immunogene Therapy.

The company said the trial was done in combination with AstraZeneca PLC's Tagrisso in patients with late-stage non-small cell lung cancer whose disease progressed after treatment with Tagrisso.

In January 2020, Genprex received FDA Fast Track Designation for the trial's patient population.

Genprex has engaged its first clinical site for the trial, and is continuing to work with a number of other cancer research centers and academic institutions to select optimal study sites.

The company expects the Phase 1 portion of the trial to enroll up to 18 patients at three clinical sites and for the Phase 2 portion to enroll 74 patients at up to 15 clinical sites. The first part of the Phase 1/2 clinical trial will be a dose escalation study.

The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization after first progression on Tagrisso, to first event or death. An interim analysis will be performed at 51 events.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

June 23, 2021 10:57 ET (14:57 GMT)

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