Genprex Announces Positive Interim Data from Phase II Clinical Trial of Oncoprex™ for Late Stage Non-Small Cell Lung Cancer
January 6, 2017
AUSTIN, TX, January 6, 2017 – Genprex, Inc. today announced positive interim data from an ongoing Phase II clinical trial (NCT01455389) evaluating its investigational immunogene therapy candidate Oncoprex™ in combination with the tyrosine kinase inhibitor (TKI) erlotinib (Tarceva®) for the treatment of late stage non-small cell lung cancer (NSCLC) patients.
The clinical trial, which is ongoing at The University of Texas MD Anderson Cancer Center, is designed to evaluate the Oncoprex/erlotinib treatment combination in up to 57 patients with late stage NSCLC, with and without EGFR mutations, who have failed at least two drug regimens. The clinical trial results in nine (9) patients evaluable to date show an overall disease control rate (stable disease, partial response or complete response) of 78%. One (1) EGFR negative patient with multiple targeted lesions experienced a durable complete response. One (1) EGFR negative patient experienced regression of targeted lesions by 24%. One (1) EGFR negative patient experienced regression of 30% in one targeted lesion, and regression of 18% over all targeted lesions. One (1) patient who was EGFR positive, but without the T790M mutation, achieved stable disease, tumor regression, and decreased metabolic activity by PET scan in multiple tumors. Three (3) additional patients achieved stable disease characterized by lack of disease progression after at least two treatments, each 21 days apart. The EGFR negative patients’ disease had progressed following chemotherapy or immunotherapy. The EGFR positive patient’s disease had progressed following treatment with Tarceva. The data from the patients treated at the time of analysis show a favorable safety profile similar to what was observed in two previous Phase I clinical trials.
“These interim data suggest that this targeted therapy may provide a viable treatment option for late stage NSCLC patients, with or without EGFR mutations, whose disease has progressed following currently available treatments,” said Rodney Varner, CEO of Genprex. “If these positive interim results are sustained in either of these populations through the trial’s conclusion, we plan to ask the FDA to grant accelerated approval for this therapy.”
Systemic, cytotoxic chemotherapy is the standard treatment for the majority of NSCLC patients. A subset of NSCLC patients (10-15 percent of Whites and 30-50 percent of Asians) carry an EGFR mutation which makes their tumors sensitive to first generation TKIs such as erlotinib (Tarceva). However, tumor resistance to TKIs frequently develops within two years, resulting in eventual disease progression. While next generation TKIs show promise in targeting resistant EGFR positive tumors that carry the mutation known as T790M, approximately one-half of EGFR positive patients (5 to 7.5% of all White and 15 to 25% of all Asian NSCLC patients) do not carry the T790M mutation. These patients do not currently have a targeted treatment option and have a very poor prognosis. Oncoprex in combination with erlotinib may be an appropriate treatment for these patients.
About Lung Cancer
Lung cancer is the second most common cancer in the U.S. There are approximately 225,000 new lung cancer cases in the U.S., and 1.8 million worldwide, every year. Lung cancer is also the leading cause of cancer death in the United States, and the 5-year survival rate of stage IV non-small cell lung cancer patients is less than 1%.
Genprex is developing Oncoprex to be a targeted treatment option suitable for a majority of NSCLC patients. Research has shown that over 80% of cancer cells of many types of cancer, including NSCLC, lack a tumor suppressor gene called TUSC2 (formerly known as FUS1), a kinase inhibitor which has been shown in-vivo to affect cell proliferation and programmed cell death. Oncoprex is an optimized TUSC2 gene encapsulated in a fatty, positively charged nanovesicle (a nanoscale hollow sphere) injected intravenously, which can specifically target cancer cells and insert wild-type TUSC2 into cellular DNA, effectively taking the place of the defective TUSC2 gene and inducing cell death.
Oncoprex immunogene therapy is designed to 1) target and kill cancer cells, 2) block mechanisms that create drug resistance, and 3) stimulate natural immune responses against cancer. Oncoprex combines features of gene therapy and immunotherapy in that it up-regulates the tumor suppressor gene TUSC2 (formerly FUS1), increases the anti-tumor immune cell population, and down-regulates PD1 and PD-L1 receptors thereby boosting the immune response to cancer.
Pre-clinical data also indicate that Oncoprex can be combined with several other approved cancer therapies to improve efficacy with minimal side effects and become a complementary therapy for other cancer treatments.
Genprex is a privately held, clinical-stage biopharmaceutical company developing immunogene therapy treatments to increase the treatment options for various cancers. Genprex’s lead product candidate, Oncoprex, has shown synergistic anti-cancer activity when combined with EGFR inhibitors and other drugs. The company is also working with world-class institutions and collaborators to in-license and develop further drug candidates. Genprex controls a portfolio of 30 issued and 6 pending patents covering tumor suppressors, therapeutics, diagnostics, nanovesicle delivery systems, and manufacturing processes. The company was founded in 2009 and is headquartered in Austin, Texas. For more information, please visit www.genprex.com or www.facebook.com/genprexinc.