Celsion Corporation (NASDAQ:CLSN) reported final clinical and translational research results from its OVATION trial, a Phase Ib dose escalating clinical study combining GEN-1, the firm’s DNA-based immunotherapy, with the standard treatment of newly-diagnosed subjects with advanced Stage III or IV ovarian cancer who will undertake neoadjuvant chemotherapy and later interval debulking surgery. GEN-1 marks as an IL-12 DNA plasmid vector made as a nanoparticle in a non-viral delivery setup to cause the sustained local secretion and production of the Interleukin-12 protein loco-regionally to the tumor place.
Celsion Corporation updated the translational report from the OVATION trial in a poster presentation at the AACR Special Conference at the Wyndham Grand Pittsburgh Downtown. The poster was presented by Dr. Khursheed Anwer, who is the EVP and Chief Scientific Officer of Celsion.
The firm also planned an Advisory Board Meeting in the last week of September with the scientific experts and clinical investigators including people from Roswell Park Cancer Institute, M.D. Anderson Cancer Center and Vanderbilt University Medical School to review and conclude clinical, translational research and safety report from the OVATION Study so as to decide the next steps forward for this thrilling new immunotherapy. With the recommendations and endorsement from the Advisory Board, firm anticipates to submit a next phase protocol with U.S.FDA later this year.
These translational research results showcase that GEN-1 in ovarian cancer patients comes to be biologically active and results in a shift in the primary tumor and in the nearby tumor region in the peritoneal cavity that enhances a pro-immune T-cell population active and change of tumor naïve T-cell into cytotoxic effector T-cells at the site of tumor microenvironment.
Dr. Kunle Odunsi expressed that these immunological variations in the local disease environment are expected to translate into clinical benefit and permit the continued development of their GEN-1 IL-12 immunotherapy as a prospective adjuvant, in first as well as second-line ovarian cancer.