Texas-based biopharmaceutical company Genprex has unveiled positive interim data from an ongoing phase II clinical trial, NCT01455389, for its lung cancer drug candidate, Oncoprex. Conducted at The University of Texas MD Anderson Cancer Center, the trial focuses on the investigational immunogene therapy drug in combination with the tyrosine kinase inhibitor erlotinib (Tarceva), targeting patients with late-stage non-small cell lung cancer (NSCLC).

Update on Oncoprex Phase II Trial

The trial has enrolled 57 patients with late-stage NSCLC, both with and without Epidermal Growth Factor Receptor (EGFR) mutations, who have not responded to at least two prior drug regimens. Notably, about half of these patients do not carry the mutations and have limited treatment options, which typically result in a poorer prognosis.

Rodney Varner, CEO of Genprex, highlighted the significance of the interim data: “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.”

Significant Findings from the Clinical Trial

The phase II trial’s results have been noteworthy: an overall disease control rate of 78% was observed, including stable disease, partial response, and one instance of complete response in an EGFR-negative patient with multiple targeted lesions. Additionally, significant regression of targeted lesions was recorded in several other patients.

Mechanism of Action and Future Implications

Oncoprex’s mechanism involves the optimized TUSC2 gene, encapsulated in a fatty, positively charged nanovesicle, and administered intravenously. This formulation targets cancer cells, integrating the TUSC2 gene into their DNA, thereby inducing cell death and potentially overcoming drug resistance.

The therapy combines gene therapy with immunotherapy, enhancing the body’s natural immune responses to fight cancer. This dual approach has shown potential in pre-clinical studies to be effective in combination with other cancer treatments, reducing side effects and improving efficacy.

The progress of Oncoprex in clinical trials offers a new ray of hope for NSCLC patients, particularly those who have exhausted other treatment options. Genprex’s innovative approach in targeting the TUSC2 gene could pave the way for a new paradigm in lung cancer treatment, especially in overcoming resistance to existing therapies.

  cancer, cancer research, clinical trial, EGFR mutations, Genprex, immunogene therapy, Lung cancer, Lung Cancer Treatment, NSCLC, Oncoprex, Tarceva