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Genprex Provides Update on Development of its Oncoprex Immunogene Therapy in Combination with Immunotherapy for Non-Small Cell Lung Cancer

(NASDAQ: ), a clinical stage gene therapy company, today provided an update on development of its lead drug candidate, Oncoprex™ immunogene therapy, in combination with immunotherapy for the treatment of non-small cell lung cancer (NSCLC).

In July 2018, the company entered a Sponsored Research Agreement with The University of Texas MD Anderson Cancer Center (“MD Anderson”) to fund a research study entitled, “A Novel Therapeutic Approach for the Treatment of Cancer Using a Combination of the Multifactorial Tumor Suppressor Gene TUSC2 and Immunotherapy.” The TUSC2 gene is the active agent in Genprex’s Oncoprex immunogene therapy. The study was budgeted to cost $2.03 million.

The study aimed to develop a novel therapeutic approach for the treatment of cancer using a combination of the tumor suppressor gene TUSC2 and immunotherapy, including immune checkpoint inhibitors and anti-PD1 and/or anti-CTLA-4 antibodies. A specific objective of the study was to validate therapeutic efficacy of the TUSC2 and immune checkpoint blockade combination in humanized cancer mouse models. This milestone was completed with positive results presented in a poster by Genprex’s collaborators from MD Anderson at the American Association of Cancer Research Meeting in April 2019, which is available on the .

Research under the Sponsored Research Agreement is continuing. Further aims of the research include evaluating TUSC2 in combination with immunostimulatory adjuvants and targeted small molecule drugs. Additional goals of the study also include identification of biomarkers that predict response to TUSC2-immunotherapy combinations

Based on data from this study and data from prior clinical and pre-clinical studies, Genprex is working with its Scientific Advisory Board and outside consultants to design a clinical trial for the study of Oncoprex in combination with a checkpoint inhibitor for treatment of non-small cell lung cancer, with the goal of being in a position to enroll patients in the first quarter of 2020.

“Recent that less than half of cancer patients qualify for approved immunotherapies based on the patient’s PD-1 or PD-L1 protein expression level,” said Julien Pham, President and Chief Operating Officer of Genprex. “Current immunotherapy treatment is only benefitting a small number of cancer patients. We are working to fill this gap by combining our lead drug candidate with approved immunotherapies to give patients more treatment options. The preclinical studies have shown encouraging data that this combination could be a viable treatment option for late-stage non-small cell lung cancer.”

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, including Genprex’s initial product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC). 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. Oncoprex 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, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance. Visit the company’s web site at or follow Genprex on , and .

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effects of Oncoprex, and of Oncoprex combined with immunotherapies, on cancer and the design and timing of our proposed clinical trials. Risks that contribute to the uncertain nature of the forward-looking statements include risks relating to the effects of Oncoprex, alone and in combination with immunotherapies, and risks relating to our ability to design, conduct and enroll patients in our proposed clinical trials. Other risks and uncertainties associated with Genprex and its lead product candidate Oncoprex are described more fully under the caption “Risk Factors” and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

EN
01/07/2019

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