Genprex (GNPX) Shares Decline After FDA Board Approves Clinical Trial

What’s going on with GNPX?

Genprex (GNPX) stock was down 3.8% after the gene therapy company received approval from the U.S. Food and Drug Administration’s centralized Institutional Review Board for its upcoming Acclaim-1 clinical trial to investigate its top drug candidate’s efficacy to treat non-small cell lung cancer. Shares of GNPX were trading at $3.54 per share on Wednesday afternoon.

In the Phase 1/2 clinical trial, Genprex’ REQORSA will be tested in combination with AstraZeneca’s Tagrisso to treat patients with late-stage lung cancer. 

The approval from the Institutional Review Board, which consists of a group of medical professionals who review and monitor biomedical research involving human participants, paves the way for the trial. It will commence at 15 U.S. clinical sites with approximately 92 patients.

What does this mean for Genprex?

Genprex received FDA Fast Track Designation for the Acclaim-1 in January 2020 and recently completed manufacturing the REQORSA supply needed for the trials. 

“The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of individuals participating as subjects in clinical research,” said Rodney Varner, president and CEO of Genprex. “With this centralized IRB approval, we have achieved another significant clinical milestone. We remain focused on completing our preparations for the Acclaim-1 clinical trial, and look forward to its commencement.”

Genprex Inc is a clinical stage gene therapy company. It is engaged in developing a new approach to treating cancer based on its novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy. Oncoprex, which has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis in cancer cells and modulates the immune response against cancer cells.