Genprex to enroll patients in study to evaluate anti-cancer agent Oncoprex with FDA-approved Erlotinib

Genprex Inc (NASDAQ:GNPX) updated a research pact Thursday with the University of Texas MD Anderson Cancer Center for a study focusing on its active anti-cancer agent Oncoprex, to be administered with US FDA-approved erlotinib, as a treatment for non-small cell lung cancer (NSCLC).

The Austin-based gene therapy company said combination therapies targeting multiple anti-cancer pathways represent a “promising approach” to achieving greater response rates.

Genprex said it had amended its agreement with MD Anderson to resume patient enrollment in its Phase 1/2 clinical trial evaluating the combination of the company’s lead product candidate Oncoprex and erlotinib for the treatment of Stage IV non-small cell lung cancer.

READ: Genprex inks research pact with the University of Texas to study anti-cancer agent Oncoprex

Previously announced interim data from nine patients enrolled in the Phase 2 portion of the clinical trial showed a disease control rate of 78%, with seven out of nine patients achieving “stable disease” or better status and “one complete” response.

In a previous Phase 1 clinical trial at MD Anderson evaluating Oncoprex as a monotherapy, five out of 23 patients with late-stage NSCLC achieved “stable disease” or better results.

“We look forward to completing the Oncoprex/erlotinib trial and expanding the study of Oncoprex in combination with other targeted and immunotherapies in the future,” Genprex CEO Rodney Varner said in a statement. “We believe the data from the more than 50 late-stage non-small cell lung cancer patients treated to date provide persuasive evidence of Oncoprex’s anti-tumor effects and favorable safety profile.”

The company said a subset of NSCLC patients carry an epidermal growth factor receptor (EGFR) mutation that makes their tumors sensitive to tyrosine kinase inhibitors (TKIs), such as erlotinib. However, even for these patients, tumor resistance to TKIs frequently develops within two years, resulting in eventual cancer progression.

While next-generation TKIs show promise in targeting resistant EGFR positive tumors that carry a mutation known as T790M, only about one-half of EGFR positive patients carry the T790M mutation. This leaves a significant majority of NSCLC patients — those who are EGFR negative and those who are EGFR positive but have become resistant to erlotinib and do not have the T790M mutation — without a targeted therapy for their cancer.

Given the tough cancer battle, Genprex said combination therapies may allow for the “expanded use” of targeted therapies and immunotherapies in a “larger population of cancer patients” who are not currently candidates for these treatments.

Story by ProactiveInvestors