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Genprex Amends Options to License Additional Cancer Fighting Technologies from the University of Texas MD Anderson Cancer Center

August 28, 2018

AUSTIN, Texas & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 28, 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, announced today that it has entered into amendments with The University of Texas MD Anderson Cancer Center (MD Anderson) to extend the terms of two option agreements between Genprex and MD Anderson pertaining the use of TUSC2, the active agent in Genprex’s lead product candidate Oncoprex, in combination with immunotherapies and the development and the use of biomarkers to predict patient response to TUSC2 therapy.

“These agreements will provide the opportunity to obtain additional patent protection for our TUSC2 gene therapy platform,” said Rodney Varner, CEO of Genprex. “With these amended agreements in place, we will continue to advance and expand our clinical development program with Oncoprex for the treatment of non-small cell lung cancer and other potential therapeutic targets.”

The first amended agreement provides Genprex with an option to exclusively license patent applications and related intellectual property relating to methods of treating cancer by combining TUSC2 with any of the immune checkpoint inhibitors known to stimulate immune responses, including but not limited to nivolumab (Opdivo®), pembrolizumab (Keytruda®), ipilimumab (Yervoy®), and anti-KIR antibodies such as lirilumab.

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 (NSCLC) 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 NK cells and CD8 T cells, and low infiltration of myeloid-derived suppressor cells (MDSC) in the tumor microenvironment.

The second amended agreement provides Genprex with an option to exclusively license an issued U.S. patent, foreign patent applications, and related intellectual property pertaining to methods for predicting a patient’s response to a TUSC2 therapy and methods for treating a patient previously predicted to have a favorable response to a TUSC2 therapeutic in conjunction with an epidermal growth factor receptor (EGFR) inhibitor and/or a protein kinase inhibitor.

Each amendment extends the term of the related option agreement to March 13, 2019, in consideration of the payment of $25,000.

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, either alone or in combination with other drugs, as well as the effect of methods for predicting patients’ response to therapy. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of TUSC2’s effect on cancer, the effect on cancer of combining TUSC2 with immunotherapies, EGFR inhibitors, or other drugs, whether or not Genprex will be able to negotiate and execute final technology license agreements under the described options, and the nature and scope of protection ultimately provided under any of the licensed patents and patent applications should such technology license agreements be executed, 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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