Celsion Corporation (NASDAQ: CLSN) has published Phase 1b OVATION 1 study data of GEN-1 combination with neoadjuvant chemotherapy in treating advanced ovarian cancer patients in the American Association of cancer research’s journal, Clinical Cancer Research.
GEN-1 didn’t show dose-limiting toxicities
The publication was authored by OVATION program study chair Premel H. Thaker et al. It is titled “GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-Escalation Study.” GEN-1 is a DNA-based interleukin-12 (IL-12) immunotherapy in Phase I/II clinical trials to treat advanced ovarian cancer in a confined setting. Most importantly, GEN-1 creates safe and long-lasting local amounts of IL-12, a pluripotent cytokine linked to cancer-fighting innate and adaptive immunity. A DNA plasmid expressing the IL-12 gene plus a synthetic polymer that facilitates plasmid distribution makes up the GEN-1 nanoparticle.
The study enrolled 18 participants suffering from stage IIIC and IV epithelial ovarian cancer in a 3+3 four GEN-1 dose-escalation testing in combination with NACT. The company evaluated 15 patients safely, with 14 undergoing intervals debulking and assessed for Response Evaluation Criteria in Solid Tumors. The study didn’t establish any dose-limiting toxicities.
Celsion generates encouraging OVATION1 study data.
Thaker said, “My colleagues and I are very encouraged by the data generated from the OVATION 1 Study, which is informing the ongoing Phase I/II OVATION 2 Study. Importantly, the repeated durable increase in lL-12 and IFN-γ levels at the tumor site for an eight-week treatment period provides for a pharmacologic remodeling of the tumor microenvironment. These immunomodulatory effects of GEN-1 may result in an increased sensitivity of tumor microenvironment to other anticancer agents including cytotoxic drugs and immunotherapies such as checkpoint inhibitors and adaptive T cell therapies. The OVATION 2 Study of concurrent GEN-1 at a dose of 100 mg/m2 weekly for up to 17 doses administered during chemotherapy is actively recruiting.”
