Genprex Inc. (NASDAQ:GNPX) said positive data from the Phase 1 portion of its Acclaim-1 clinical trial evaluating REQORSA Immunogene Therapy in combination with Tagrisso in late-stage non-small cell lung cancer (NSCLC) will be published in an abstract at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023 in Chicago, Illinois.
"We are thrilled to have our abstract, which reports positive results from the Phase 1 portion of our Acclaim-1 clinical trial, published at the ASCO Annual meeting," said Dr Mark Berger, chief medical officer at Genprex in a statement. "We are encouraged by the favorable safety profile of REQORSA, as well as the preliminary efficacy data we have observed, and we believe this data will support our advancement to the Phase 2 portion of the clinical trial."
The abstract reports preliminary results from eight patients in Genprex's Phase 1 portion of its Acclaim-1 clinical trial evaluating REQORSA Immunogene Therapy (quaratusugene ozeplasmid) with Tagrisso (osimertinib) in patients with advanced, EGFR mutant NSCLC whose disease progressed after Tagrisso. REQORSA was generally well tolerated, as there were no dose-limiting toxicities. Full safety and efficacy data on the Phase 1 portion of the study will be presented at an upcoming medical meeting.
While the Phase 1 portion of the clinical trial is designed primarily to assess safety, promising efficacy results were also observed. The extended and ongoing progression-free survival (PFS) of each of these patients is significantly greater than the median PFS observed from treatment with osimertinib alone in this treatment setting in several prior clinical trials and is consistent with long-term PFS seen in prior clinical trials of REQORSA. PFS is the primary endpoint of both the Phase 2 expansion portion and the Phase 2 randomized portion of the Acclaim-1 trial.
"Demonstrating a favorable safety profile substantially de-risks the REQORSA development program and is a major accomplishment for Genprex," said Rodney Varner, chairman, president, and chief executive officer of Genprex.
"It is encouraging that several patients who were progressing on their previous therapy are now having long periods of response and stable disease in the Phase 1 portion of the study. We wish to thank the patients and investigators participating in our clinical trials and our investors who make it possible to move our drug candidates forward toward availability for patients in need," Varner added.
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. The company'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 to provide novel treatment approaches.
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