Celsion Corporation will present two posters with key findings of its IL-12 gene-mediated immunotherapy, GEN-1, in ovarian cancer.
The presentations will be made at the American Society of Clinical Oncology (ASCO) – Society for Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Symposium in Orlando, Fla., Feb. 23-25.
The first poster, titled “Phase I study and activity of formulated IL-12 plasmid administered intraperitoneally in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer,” will report clinical results from the OVATION Study.
The Phase 1b dose-escalating clinical trial (NCT02480374) is testing GEN-1 administered in combination with standard neoadjuvant (pre-surgery) chemotherapy in patients newly diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer, who will undergo interval debulking surgery.
The second poster, titled “Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer,” will report translational data from the OVATION Study and previous GEN-1 clinical trials.
The OVATION Study has four dose groups meant to enroll three to six patients each, to identify a safe, tolerable, and effective dose of GEN-1. The first three groups enrolled three patients each and provided promising efficacy results.
In January, Celsion revealed preliminary data, including the first three patients enrolled in the fourth group. In the first 12 patients dosed in total, which include patients from the fourth and final group, the combination therapy has shown promising efficacy signs, including 100% disease control rate and 75% objective response rate, with no dose-limiting toxicities.
Celsion now expects to enroll three additional patients in the fourth group by the end of this quarter and to report OVATION’s final data by mid-2017. Future studies will include a Phase 1b clinical trial testing GEN-1 in combination with Avastin (bevacizumab) and Doxil (doxorubicin).
Khursheed Anwer, PhD, Celsion’s executive vice president and chief science officer will present both posters.
“Our hypothesis is that GEN-1 plus neoadjuvant chemotherapy treatment will reprogram the tumor immune microenvironment towards a potent antitumor immune response,” Anwer said in a press release. “The available data demonstrate highly relevant immunological changes in the tumor immune environment, such as tumor infiltration of cytotoxic T-cell lymphocytes and a reduction of certain immunosuppressive signals, which supports the immune activating role of GEN-1 in this patient population. Evidence of immune activation following the treatment is also supported by increases in IFN-g, a potent mediator of the anti-tumor immune response associated with IL-12 action. We are excited to present at the ASCO-SITC symposium, and look forward to sharing the impressive clinical and translational results with the scientific community,” Anwer said.
Celsion’s GEN-1 is a lipid vesicle that specifically targets tumor cells and contains a DNA molecule with the IL-12 gene. IL-12 is an immune-stimulatory molecule that activates the immune system, and by delivering it directly into the tumor site, GEN-1 reduces the serious toxicities associated with exacerbated immune activity in other areas of the body.