Celsion Corporation Reports Data Safety Monitoring Board Recommendation to Continue Dosing Patients in the Phase II Portion of the Ovation 2 Study with Gen-1 in Advanced Ovarian Cancer
July 19, 2021 at 08:00 am EDT
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Celsion Corporation announced that following a pre-planned interim safety review of 55 as treated patients randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer, the Data Safety Monitoring Board has unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. No dose-limiting toxicities were reported. The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer 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 OVATION 2 Study is designed with an 80% confidence interval for an observed Progression Free Survival Hazard Ratio of 0.75, which would mean an approximate 33% improvement in risk for cancer progression when comparing the treatment arm with the control arm. GEN-1 is an immunotherapy that produces safe and durable local levels of IL-12, 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. The company also announced that more than 50% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data from the first 36 patients who have undergone interval debulking surgery are as follows: Of the 36 patients who have undergone interval debulking surgery in the OVATION 2 Study: 20 patients were treated with GEN-1 at a dose of 100 mg/m² plus NACT, with 16 out of 20 patients having a complete tumor resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed; and 16 patients were treated with NACT only, with 9 out of 16 patients having R0 resections. When combining these results with the surgical resection rates observed in the Company’s prior Phase Ib dose-escalation trial, a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to NACT: The objective response rate as measured by Response Evaluation Criteria in Solid Tumors criteria for the 16 patients treated with NACT only were comparable, as expected, to the 20 patients treated with GEN-1 at a dose of 100 mg/m² plus NACT, with both groups demonstrating an approximate 80% ORR.
Imunon, Inc. is a clinical-stage biotechnology company. The Company is focused on advancing a portfolio of treatments that harness the bodyâs natural mechanisms across an array of human diseases. The Company is developing non-viral Deoxyribonucleic acid (DNA) technology across four modalities. The first modality, TheraPlas, is developed for the coding of proteins and cytokines in the treatment of solid tumors. The second modality, PlaCCine, is developed for the coding of viral antigens that can elicit a strong immunological response. The third modality, FixPlas, concerns the application of Imunonâs DNA technology to produce universal cancer vaccines, also called tumor associated antigen cancer vaccines. The fourth modality, IndiPlas, is in the discovery phase and is focused on the development of personalized cancer vaccines, or neoepitope cancer vaccines. Its lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer.
Celsion Corporation Reports Data Safety Monitoring Board Recommendation to Continue Dosing Patients in the Phase II Portion of the Ovation 2 Study with Gen-1 in Advanced Ovarian Cancer