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Genprex Enters Agreement with the University of Texas MD Anderson Cancer Center to Study Oncoprex in Combination with Immunotherapies

July 26, 2018

New study will evaluate synergistic effect of Oncoprex gene therapy on checkpoint inhibition

Study may identify biomarkers that can predict the response to therapy across different cancers

AUSTIN, Texas & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul. 26, 2018-- Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, has entered a Sponsored Research Agreement (“Agreement”) with The University of Texas MD Anderson Cancer Center under which Genprex will sponsor a pre-clinical study, entitled “A Novel Therapeutic Approach for the Treatment of Cancer Using a Combination of the Multifactorial Tumor Suppressor Gene TUSC2 and Immunotherapy,” to be conducted under the direction of Jack A. Roth, MD, FACS. TUSC2 is the active agent in Genprex’s investigational drug candidate Oncoprex™.

The study, which is built upon strong data from pre-clinical research conducted at MD Anderson, is intended to develop a novel therapeutic approach for the treatment of cancer using a combination of the multifactorial tumor suppressor gene TUSC2 and immunotherapy, including the immune checkpoint inhibitors anti-PD1 and/or anti CTLA-4. The study will include the identification of biomarkers to predict the response to TUSC2-immunotherapy combinations.

Under the Agreement, MD Anderson will provide all necessary personnel, equipment, supplies, facilities and resources to perform the study; and Genprex will pay MD Anderson an amount equal to its expenditures and reasonable overhead in conducting the study in an amount of $2.0 million.

"This research program will evaluate the ability of TUSC2 gene therapy to synergistically enhance the effect and clinical utility of anti-PD1 and/or anti-CTLA-4 therapies,” said Rodney Varner, Chairman and Chief Executive Officer of Genprex. “Identifying biomarkers that can predict response rates for Oncoprex-immunotherapy combinations may allow us to explore the utility of this treatment regimen in a broader array of cancers.”

Varner added, “While immunotherapies represent an important advance in treating cancer, even in highly immunogenic tumors, the majority of patients do not respond to checkpoint inhibition. Combination therapies targeting multiple anti-cancer pathways represent a promising approach to achieving greater response rates, and may also allow the expanded use of immunotherapies in a larger population of cancer patients who are not currently candidates for these treatments.”

Researchers at MD Anderson reported data from preclinical research at the 2017 meeting of the American Association for Cancer Research demonstrating that TUSC2 alone or in combination with checkpoint blockade (anti-PD-1 and/or anti-CTLA4) significantly prolonged mouse survival in a non-small cell lung cancer metastasis model compared to checkpoint blockade alone. The greatest increase in survival was seen with TUSC2 combined with checkpoint blockade. The treatment response was associated with high infiltration of natural killer (NK) cells and CD8 T cells, and low infiltration of myeloid-derived suppressor cells (MDSC) in the tumor microenvironment.

About Genprex, Inc.

Genprex, Inc. is a clinical stage gene therapy company developing a new approach to treating cancer, based upon a novel 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.

For more information, please visit www.genprex.com or www.facebook.com/genprexinc.

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 effect of TUSC2 on cancer, the services we expect to receive from MD Anderson and the effect of those services on the development of Oncoprex. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of TUSC2’s effect on cancer, MD Anderson’s ability to provide services to us and our ability to utilize MD Anderson’s services, the ability of MD Anderson’s services to influence the development of Oncoprex, as well as the timing and success of our clinical trials and planned clinical trials of TUSC2 and Oncoprex and our other potential product candidates and the timing and success of obtaining FDA approval of Oncoprex and our other potential product candidates. These and other risks and uncertainties 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.

 

Source: Genprex, Inc.

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