On August 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, reported 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 (Press release, Genprex, AUG 28, 2018, View Source [SID1234529104]).
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"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 (AACR) (Free AACR Whitepaper) 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.