Genprex Initiates Site Recruitment for Acclaim-1 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer

 

Source: Genprex, Inc. 11/30/2020

Acclaim-1 trial combines REQORSA™ immunogene therapy drug with AstraZeneca’s Tagrisso®

Company expects to recruit approximately 10 sites across the United States

Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, is pleased to announce it has commenced clinical trial site recruitment for its upcoming Acclaim-1 clinical trial for the treatment of non-small cell lung cancer (NSCLC). As planned, the timing of the patient recruitment and enrollment puts the Company on track for its Acclaim-1 clinical trial to commence in the first-half of 2021.  

Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines Genprex’s lead drug candidate, REQORSA™ immunogene therapy with AstraZeneca PLC’s Tagrisso in patients with late stage NSCLC with mutated epidermal growth factor receptors (EGFRs), whose disease progressed after treatment with Tagrisso. Genprex received U.S. Food and Drug Administration (FDA) Fast Track Designation for its Acclaim-1 patient population in January of 2020.

“Our clinical team is engaging with prestigious cancer centers and research institutions across the U.S. to ensure we select optimal study sites, which play an important role in the success of a clinical trial,” said Rodney Varner, President and Chief Executive Officer of Genprex. “We look forward to working with leading clinical investigators who will help drive our mission to bring forth a treatment for advanced lung cancer patients.”

The Company plans to conduct the Acclaim-1 clinical trial in approximately 10 U.S. sites with about 100 patients (9-18 patients in the Phase 1 component and 82 patients in the Phase 2 component). An interim analysis will be performed after 53 events (i.e., progression of disease or death).

Additional information on the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone.

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.