Celsion Corporation (NASDAQ:CLSN) has recently announced the latest translational data from the OVATION study of the Phase 1b dose clinical trials that combined GEN-1, Company’s 1L-12 gene-mediated immunotherapy, together with standard care for treatment of the lately-diagnosed patients of Stage 3 and 4 ovarian cancer. The patients went through the neoadjuvant chemotherapy (NACT) and afterwards take the interval debulking surgery.
The translational research data was analyzed with the leading immune-oncology specialists from Roswell Park Cancer Institute. The key translational data from the first 12 of the 15 participants were summarized as follows:
- The changes in the stimulated immune cytokines, pro-tumor VEGF, and IFN- γ levels. The tracked immunological changes were consistent and were in line with the IL-12 based mechanism.
- The effects examined in IHC analysis were reported to be decreasing in the mass of the immunosuppressive T-cell signals including the FoxP3, PD-1, PDL-1, and IDO-1) ns an increase in the CD8+cells in the tumor
- The CD8+ cells to immunosuppressive ratio increased gradually by 75% in patients proposing an entire shift in tumor surroundings following the treatment with GEN-1. The increase in CD8+ cells is an indication and a great predictor of an overall improvement.
The findings shows that GEN-1 is biologically active in the ovarian cancer patients and can develop a dramatic change in the tumor microenvironment by promoting the pro-immune T-cell population.
According to Dr. Khursheed Anwer, the executive vice president and chief science officer at Celsion, the diverse immunological shift in the confined tumor environment is a clinical indication that warrants continuous development of GEN-1 and IL-12 immunotherapy as a possible adjuvant in the first and second phases of ovarian cancer.
In addition, the pro-immune changes in the cancer disease microenvironment also support the findings when GEN-1 is combined with other interesting immune-oncology therapies such as the adaptive T-cell and other check-point inhibitors.
Celsion had previously announced updates of the research findings from its OVARIAN study presented to the American Society of Clinical Oncology in June.