The FDA has granted a fast track designation to the DNA-mediated interleukin-12 (IL-12) immunotherapy GEN-1 for use in the treatment of patients with advanced ovarian cancer, according to an announcement from Celsion Corporation.Previously, findings from the phase 1 portion of the phase 1/2 OVATION 2 trial (NCT033393884) showed that 88% of patients with newly diagnosed, stage III/IV ovarian cancer (n = 7/8) who received GEN-1 plus neoadjuvant chemotherapy (NACT) experienced a complete tumor resection (R0), indicative of microscopically margin-negative resection in which no gross or microscopic tumor remained in the tumor bed. Patients who received NACT only achieved a R0 resection rate of 50%.

“Fast track designation is an important step in developing GEN-1 for advanced ovarian cancer. Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market,” Michael H. Tardugno, chairman, president, and chief executive officer of Celsion, stated in a press release. “We are optimistic that GEN-1 represents a game-changer for women with advanced ovarian cancer who have limited treatment options.”

Developed using Celsion’s exclusive TheraPlas platform technology, GEN-1 is an IL-12 DNA plasmid vector that is enclosed in a nanoparticle delivery system that permits cell transformation followed by persistent, local emission of the IL-12 protein. Importantly, IL-12 is an active cytokine that is involved in the initiation of strong anticancer immunity that acts through the induction of T-lymphocyte and natural killer cell production.

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