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Celsion Completes Enrollment of the Phase I/II OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

110 Patients Enrolled in Study Comparing Novel Gene-Mediated Immunotherapy plus Neoadjuvant Chemotherapy versus Neoadjuvant Chemotherapy Alone

Excerpt from the Press Release:

LAWRENCEVILLE, N.J., Sept. 15, 2022 (GLOBE NEWSWIRE) — Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has completed enrollment with 110 patients. GEN-1 is the Company’s IL-12 gene-mediated immunotherapy. Topline results are expected in the second half of 2023.

The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor. The study is designed with an 80% confidence interval to show an approximate 33% improvement in progression-free survival when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT only).

IL-12 is a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 gene and a synthetic polymer facilitating plasmid delivery vector. Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.

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