On November 20, 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, reported a clinical and corporate update, and the filing of quarterly results for the third quarter ended September 30, 2018 on Form 10-Q with the Securities and Exchange Commission (Press release, Genprex, NOV 20, 2018, View Source [SID1234531511]).
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Rodney Varner, Chairman and CEO, remarked, "Over the past quarter, we have taken steps to advance our clinical development activities. We extended our ability to strengthen our patent protection for our TUSC2 gene platform, expanded our collaborations and augmented our team. Most notably, we added Jan Stevens, RN, whose expertise in clinical operations will be invaluable as we look to expand our Phase I/II clinical study evaluating Oncoprextm in combination with Tarceva for treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC)."
Julien L. Pham, MD, MPH, President and Chief Operating Officer, stated, "We are confident in our choice of Aldevron as a plasmid manufacturing partner and look forward to working with them to continue our clinical trials of our immunogene therapy Oncoprex for the treatment on non-small cell lung cancer."
Clinical Development and Corporate Update
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.
Entered into an agreement with Aldevron, a leading contract manufacturing organization, to supply TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for use in Genprex’s clinical development program evaluating Oncoprex for the treatment of NSCLC.
Entered into agreements with additional contract manufacturing organizations to assist with manufacturing scale-up and transfer of manufacturing processes from manufacturing facilities of the University of Texas MD Anderson Cancer Center to commercial facilities.
Appointed Jan Stevens, RN as Vice President of Clinical Operations in October 2018. Ms. Stevens joined the Company’s Cambridge office to lead clinical operations and support corporate development efforts, focusing on expanding research and clinical development opportunities, including the expansion of Genprex’s Oncoprex + Tarceva combination trial across multiple US sites.
Third Quarter 2018 Financial Update
Genprex’s research and development expense was $489,689 for the three months ended September 30, 2018 as compared to $55,517 for the three months ended September 30, 2017. The increase in the current year period was driven entirely by increased R&D and commercialization activities associated with the development of our drug candidate and the progression of our Phase I/II clinical trial at MD Anderson.
Genprex had a cash position of $10.3 million as of September 30, 2018.