Texas based bio-pharma Genprex has announced positive interim data from an ongoing phase II clinical trial of its lung cancer drug candidate Oncoprex.
Titled as NCT01455389, the phase II trial of Oncoprex is evaluating the investigational immunogene therapy drug candidate in combination with erlotinib (Tarceva), a tyrosine kinase inhibitor (TKI) in patients with late stage non-small cell lung cancer (NSCLC).
Potential Lung Cancer Drug Oncoprex Phase II Trial Update
The Oncoprex phase II trial is being carried out at The University of Texas MD Anderson Cancer Center in 57 patients with late stage NSCLC with and without Epidermal Growth Factor Receptor (EGFR) mutations, who did not respond to at least two drug regimens.
About one half of the patients did not carry out these mutations during the lung cancer drug trial. Such patients did not have any targeted treatment option and had poor prognosis, said the pharma company.
Rodney Varner, CEO of Genprex said: “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.
“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”.
Genprex’s Lung Cancer Drug Candidate Oncoprex Phase II Trial Results
Genprex’s phase 2 clinical trial results of Oncoprex with erlotinib revealed that nine patients showed an overall disease control rate of 78% like stable disease, partial response and complete response to the drug combination.
Complete response was experienced by one EGFR negative patient with multiple targeted lesions.
The lung cancer drug phase 2 results also showed that one EGFR negative patient showed regression of targeted lesions by 24% while one EGFR negative patient showed 30% regression in one targeted lesion and 18% regression over all targeted lesions.
One EGFR positive patient in the lung cancer drug trial, without T790M mutation achieved stable disease, tumor regression and reduced metabolic activity by PET scan in multiple tumors.
Another three patients achieved stable disease after two treatments, each of them separated by 21 days. The disease did not progress in these patients as per the data recorded in the Genprex lung cancer drug trial.
The disease progressed in EGFR negative patients following chemotherapy or immunotherapy.
It was shown to have progressed in EGFR positive patients post treatment with Tarceva.
The data from these patients undergoing treatment at the time of analysis had shown the similar safety profile as observed in two previous Phase I clinical trials of the lung cancer drug candidate.
Standard treatment for most of the NSCLC patients is systemic and cytotoxic chemotherapy. Some of the NSCLC patients undergo EGFR mutations which make the tumors sensitive to first generation TKIs like erlotinib (Tarceva).
Within a span of two years, tumor resistance to TKIs develops and results in progression of the disease.
The next generation TKIs has shown promising result in targeting resistant EGFR positive tumors which carry out T790M mutation.
Potential Lung Cancer Drug Oncoprex Mechanism of Action
Oncoprex is a targeted treatment option for most of NSCLC patients. As per research studies, 80% of cancer cells lack a tumor suppressor gene known as TUSC2 which is a kinase inhibitor and affects cell proliferation and programmed cell death.
Genprex lung cancer drug candidate Oncoprex is an optimized TUSC2 gene that is encapsulated in a fatty and positively charged nanovesicle and injected intravenously.
This specifically targets cancer cells and inserts the TUSC2 into cellular DNA and replaces the defective TUSC2 gene and induces cell death.
Oncoprex immunogene therapy is developed in order to target and kill the cancer cells. Oncoprex is said to block the mechanisms that develops drug resistance.
The lung cancer drug candidate also stimulates natural immune responses to treat cancer.
Oncoprex, comprising gene therapy and immunotherapy, up-regulates the tumor suppressor gene TUSC2 thereby increase the anti-tumor cells along with down regulating PD1 and PD-L1 receptors and boosts the immune response to cancer.
The pre-clinical data of Oncoprex has shown that it can be combined with other cancer treatment options for improving efficacy by reducing side effects.
Oncoprex can potentially become a complementary therapy for other cancer treatments as per Genprex.