Genprex Provides Clinical and Corporate Update for Second Quarter 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, today announced a clinical and corporate update, and the filing of quarterly results for the second quarter ended June 30, 2018 on Form 10-Q with the Securities and Exchange Commission.

Rodney Varner, Chairman and CEO, remarked, “We have made significant progress in recent months to advance the development of Oncoprex™ for treatment of non-small cell lung cancer (NSCLC), including engaging collaborators with expertise and other resources necessary for important pre-clinical and clinical services. We also obtained an additional $10 million in capital, which provides additional financial resources to position the Company to achieve its critical milestones in its path toward developing and commercializing Oncoprex. ”

Julien L. Pham, MD, MPH, President and Chief Operating Officer, stated, “We are moving toward resuming enrollment in the Phase I/II clinical evaluating the combination of Oncoprex™ and erlotinib (Tarceva®) for the treatment of Stage IV non-small cell lung cancer (NSCLC), adding an additional preclinical trial to study Oncoprex in combination with immunotherapies, and progressing with manufacturing scale-up.”

Clinical Development Highlights (May 2018 to present)

• Selected Accenture to provide clinical data management services to help accelerate the clinical development of Genprex’s lead drug candidate, Oncoprex™.
• Entered an agreement to use WIRB-Copernicus Group (WCG) to provide site selection and feasibility services, including Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) oversight for new clinical trial sites that Genprex anticipates adding to participate in its Phase I/II clinical trial evaluating the combination of Oncoprex^TM and erlotinib (Tarceva®) in NSCLC.
• Selected 4Clinics as a CRO to provide clinical and regulatory support for the clinical development program in the form of biostatistics, statistical programming and analysis, as well as medical and scientific writing for the Phase I/II clinical trial.
• Entered an agreement with The University of Texas MD Anderson Center under which Genprex is sponsoring a pre-clinical study 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. This study will include the identification of biomarkers to predict the response to TUSC2-immunotherapy combinations.
• Amended its agreement with The University of Texas MD Anderson Cancer Center to resume patient enrollment in its Phase I/II trial evaluating the combination of Oncoprex™ and erlotinib (Tarceva®) for the treatment of Stage IV non-small cell lung cancer (NSCLC).

Corporate Update