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Non-viral gene therapy for bladder cancer with positive early clinical results
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Complete remission rate of 83% | Non-viral gene therapy for bladder cancer with positive early clinical results
enGene announced on February 08 that its innovative non-viral gene therapy EG-70, based on its proprietary technology platform for local delivery to mucosal tissue, is being used in the treatment of patients with high-grade non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacille Calmette-Guerin (BCG) positive results in Phase 1/2 clinical trials.
For more than 30 years, BCG immunotherapy has been the standard of care for NMIBC. However, the 60% rate of disease recurrence and progression after BCG therapy suggests that patients with NMIBC still have an urgent unmet medical need.
Ultimately, most NMIBC patients who do not respond to BCG will undergo cystectomy, which removes the bladder at the same time as other surrounding organs.
enGene’s DDX platform utilizes chitosan derivatives to deliver DNA or RNA into mucosal tissues. EG-70 is a novel non-viral gene therapy that utilizes plasmids encoding two RIG-I agonists to stimulate the innate immune system, and IL-12 to stimulate the adaptive immune system.
By stimulating both branches of the immune system, intravesical administration of EG-70 produced significant tumor regression in a preclinical model of bladder cancer and induced potent immune memory.
The clinical trial results showed that EG-70 was safe and well tolerated, with encouraging clinical efficacy in patients with high-grade NMIBC carcinoma in situ who failed BCG therapy. Of the 6 patients evaluable for efficacy at 3 months, 5 achieved complete remission (CR). This marks an 83% completion rate.
“The response observed with EG-70 is an important step toward the goal of avoiding cystectomy in NMIBC patients,” said lead investigator Gary Steinberg, Ph.D., of New York University. “If follow-up studies observe similar results, I believe this innovative intravesical monotherapy will have a meaningful impact on the lives of high-risk NMIBC patients.”
(source:internet, reference only)