Expert Discusses Celsion’s Ovarian Cancer Immunotherapy GEN-1; Phase 1/2 Trial Still Enrolling

Expert Discusses Celsion’s Ovarian Cancer Immunotherapy GEN-1; Phase 1/2 Trial Still Enrolling
The ovarian cancer immunotherapy candidate GEN-1, which is being tested in a Phase 1/2 clinical trial in newly diagnosed patients with advanced disease, was the focus of a recent call with a gynecologic oncology expert. The OVATION 2 trial (NCT03393884) is enrolling at 34 sites across the U.S. It will test the safety and effectiveness of GEN-1 in up to 130 patients with newly diagnosed advanced or metastatic ovarian (stage III/IV), fallopian tube, or primary peritoneal cancer. GEN-1, developed by Celsion Corporation, is a nanoparticle containing a vector with the DNA sequence for the pro-inflammatory protein interleukin (IL)-12. Delivery to the tumor cells is followed by release of IL-12, which induces anti-cancer immune responses by activating immune T-cells and natural killer (NK) cell proliferation. The call about ovarian cancer treatments and emerging opportunities was led by Premal H. Thaker, MD, a scientist key in the development of GEN-1, and was hosted by the investment bank Oppenheimer & Co. All slides from the presentation may be viewed here. Other potential treatments for patients with ovarian cancer were discussed. Thaker is study chair and a member of the Data Safety Monitoring Board for OVATION 2, and was a principal investigator for the OVATION 1 Phase 1b study (NCT02480374), which studied GEN-1 in combination with standard chemotherapy for newly-diagnosed ovarian cancer patients scheduled for surgery. OVATION 1 results showed that all 14 patients who received the two higher GEN-1 doses (61 mg/m2 and 79 mg/m²), along with chemotherapy, responded at least partially to treatment, while 88% had complete tumor removal after surgery. In contrast, partial or complete cancer disappearance was seen in only 60% of those on the two lower
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