Genprex has entered a sponsored research agreement with The University of Texas MD Anderson Cancer Center to further explore its investigational therapeutic candidate Oncoprex.
The company will provide $2 million to MD Anderson researchers to fund a new preclinical study that will evaluate the anti-cancer potential of Oncoprex when used in combination with available immunotherapies, such as anti-PD1 and anti-CTLA-4 checkpoint inhibitors.
The study, “A Novel Therapeutic Approach for the Treatment of Cancer Using a Combination of the Multifactorial Tumor Suppressor Gene TUSC2 and Immunotherapy” will be led by Jack A. Roth, MD.
“While immunotherapies represent an important advance in treating cancer … 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,” Rodney Varner, chairman and CEO of Genprex, said in a press release.
Oncoprex is a gene therapy designed by Genprex to specifically target cancer cells. The proprietary technology uses tiny vesicles, calls nano-vesicles, that are administered directly into the blood and can deliver TUSC2, a tumor suppressor gene that is reduced or deleted in about 82 percent of non-small cell lung cancers (NSCLC) and 100 percent of small-cell lung cancers (SCLC).
Previous data from preclinical studies at MD Anderson have shown that TUSC2 alone or in combination with checkpoint inhibitors significantly reduces lung cancer size in mice, while promoting an enhanced anti-cancer immune response. This positive result led to an enhanced treatment response and improved survival rates when compared to checkpoint inhibitors alone.
The recently announced preclinical study will evaluate the clinical activity and utility of Oncoprex in combination with available immunotherapies as a new therapeutic approach for treating cancer. Researchers also are planning to identify potential biomarkers that could be used to predict the response to TUSC2-immunotherapy combinations.
“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 said.
Genprex, in collaboration with MD Anderson researchers, is currently analyzing the anti-cancer activity of Oncoprex in combination with Genentech’s Tarceva (erlotinib) in patients with stage 4 NSCLC.
That ongoing Phase 1/2 clinical trial (NCT01455389) recently resumed patient enrollment, as announced in a press release.
Interim data of the trial revealed that Oncoprex-Tarceva combo could support disease control in about 78 percent of treated patients. Seven out of nine patients achieved stable disease or better, including one patient who had a complete response (no detectable cancer cells).
“We look forward to completing the Oncoprex/erlotinib trial and expanding the study of Oncoprex in combination with other targeted and immunotherapies …, ” Varner said.
