On March 2, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported that a poster on the Company’s Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has been accepted for presentation at the Virtual Annual Meeting on Women’s Cancer, sponsored by the Society of Gynecologic Oncology (Press release, Celsion, MAR 2, 2021, View Source [SID1234575957]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The conference is being held March 19-25, 2021. The OVATION 2 Study design is being presented as a poster entitled "A Phase I/II Study Evaluating Intraperitoneal GEN-1 in Combination with Neoadjuvant Chemotherapy in Patients with Newly Diagnosed Advanced Epithelial Ovarian Cancer (EOC)" in the "Trials in Progress" poster session from March 19 to 25 (8 pm to 11 pm each day). GEN-1 is Celsion’s DNA-mediated interleukin-12 (IL-12) immunotherapy designed using TheraPlas, its proprietary, synthetic, non-viral nanoparticle delivery system platform. Poster authors are: P.H. Thaker, R.W. Holloway, L. Kuroki, S. E. DePasquale, W.H. Bradley, A. ElNaggar, M.C. Bell, R.P. Rocconi, A. Bregar, M.D. Indermaur, C. Gunderson, B. Pothuri, R. Agajanian, D. Warshal, D. Provencher, M. McHale, V. John, M. Bergman, S. Lau, L. Musso, K. Anwer, N. Borys, C.A. Leath III and the poster will be available for virtual viewing during the meeting.
"We are delighted that the Society of Gynecologic Oncology has accepted this poster for presentation," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "The poster authors, led by the Study Chair of the OVATION 2 Study Dr. Premal Thaker of Washington University School of Medicine in St. Louis, are a Who’s Who of key opinion leaders in women’s health. Celsion is grateful to have such luminaries represent our study to their peers."
The poster describes the OVATION 2 Study, which combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments, the goal of which is to delay progression and improve overall survival. The OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (standard of care + GEN-1) with the control arm (standard of care alone).
The poster will be available View Source on March 19, 2021.
The Company recently announced that to date it has enrolled approximately one-third, or 34 patients, of the anticipated 110 patients to be enrolled into the OVATION 2 Study, of which 20 are in the treatment arm and 14 are in the control. Currently, 28 patients have had their interval debulking surgery with the following results:
13 of 16, or 81%, of patients treated with GEN-1 had a R0 resection, which indicates a microscopically margin-negative complete resection in which no gross or microscopic tumor remains in the tumor bed.
7 of 12 patients, or 58%, of patients in the control arm had an R0 resection.
This interim data represents a 40% improvement in R0 resection rates for GEN-1- patients compared with control arm patients and is consistent with the reported improvement in resection scores noted in the encouraging Phase I OVATION 1 Study, the manuscript of which has been submitted for peer review publication.
Celsion also announced last week that GEN-1 had received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need.
About GEN-1 Immunotherapy
GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and recently completed a Phase Ib dose-escalation trial (OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.
About the Virtual Annual Meeting on Women’s Cancer
The Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer will be a fully virtual meeting, allowing participants to access high-quality content and engage remotely from around the world in a platform that will be designed explicitly for this meeting. SGO is working hard to provide a great virtual experience with the latest gynecologic cancer research and education you have come to expect at the Annual Meeting on Women’s Cancer. All education sessions will be recorded and available through the virtual platform for attendees who register for the meeting by March 25, 2021.