Genprex to Focus Its Clinical Efforts on Oncoprex in Combination Therapy with Osimertinib for Non-Small Cell Lung Cancer (NSCLC) - Seite 2

Genprex plans to file an amendment to its Investigational New Drug (IND) application with the FDA for the Oncoprex and osimertinib combination therapy trial within the first quarter of 2020. Upon FDA acceptance of the amendment, the Company expects to be in a position to enroll patients shortly thereafter. The Company believes that enrollment in the new clinical trial may be rapid, as the tumors of almost all patients who are treated with osimertinib progress after treatment, and these patients may be candidates for its clinical trial combining Oncoprex with osimertinib, for which the Company received Fast Track Designation.

Thus, given the changing landscape in NSCLC and the recent Fast Track Designation, the Company believes prioritizing the combination therapy of Oncoprex with osimertinib represents the most efficient way to advance its lead drug candidate through the clinical process for FDA approval, to have the best commercial success in the $17.9 billion global lung cancer market and to make its treatment available to patients as soon as possible.

While prioritizing the combination therapy of Oncoprex with osimertinib, the Company will also proceed with its plan to file an IND for the additional combination therapy of Oncoprex combined with the immunotherapy drug pembrolizumab (marketed as Keytruda by Merck in the U.S.) for NSCLC.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for cancer patients based upon a unique proprietary technology platform. Genprex’s platform technologies are designed to administer cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells, where they express proteins that are missing or found in low quantities. The company’s lead product candidate, Oncoprex immunogene therapy for non-small cell lung cancer (NSCLC), has a multimodal mechanism of action whereby it 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. Oncoprex has also been shown to block mechanisms that create drug resistance. In January 2020, the FDA granted Fast Track Designation for Oncoprex immunogene therapy for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso). For more information, please visit the company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.