Celsion Provides Summary of Research and Development Day Held on October 12, 2017
The GEN-1 immunotherapy presentations focused on the Company's clinical and translational research data from its OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1, the Company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced Stage III/IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. GEN-1 is an interleukin-IL-12 (IL-12) DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and secretion of the IL-12 protein loco-regionally at the tumor site. The lead clinical investigator for the OVATION Study and leading immuno-oncology experts from the
Khursheed Anwer, Ph.D., Celsion's Executive Vice President & Chief Scientific Officer, presented the following:
- GEN-1 immunotherapy is a powerful pro-immune modulator designed to modulate the tumor microenvironment through the delivery of the potent immune agent IL-12 into the peritoneal cavity in a local and persistent manner.
- IL-12 shifts the tumor microenvironment from immune suppressive to immune activation.
- GEN-1 immunotherapy results in the loco-regional production of the potent cytokine IL-12 avoiding toxicities and poor pharmacokinetics associated with systemic recombinant IL-12 protein; lasts up to one week; Dosing can be repeated making GEN-1 immunotherapy ideal for long-term maintenance therapy.
Premal H. Thaker, M.D., Associate Professor in Gynecologic Oncology, Washington University School of Medicine, St. Louis, Missouripresented the final clinical data from the Phase Ib dose-escalating OVATION Study:
- Neoadjuvant treatment approach to ovarian cancer has been gaining greater support over the last few years due to safety benefits; Addition of GEN-1 to neoadjuvant chemotherapy was safe and well tolerated.
- The R0 margin negative resection score in 64% of patients treated in the OVATION Study appeared to be higher than what you see with neoadjuvant chemotherapy alone; R0 score of 100% in the highest dose group is impressive.
- Progression Free Survival (PFS) of over 14 months in the as-treated patient population is on a positive trend since only 2 out of 16 patients have progressed to-date.
- The patient population in the OVATION Study was highly advanced (94% at Stage IIIC - IV); better results are anticipated in a mixed population trial.
Richard C. Koya, M.D., Ph.D., Associate Professor of Oncology and Immunology, Director of the Vector Development & Production Facility, Associate Director of the Center for Immunotherapy, Roswell Park Cancer Institute, Center for Immunotherapy, Buffalo, NYpresented the following translational research data from the OVATION Study:
- GEN-1 treatment when administered in combination with standard of care increased the levels of immune-stimulatory cytokines and tumor infiltrating lymphocytes in a manner that is consistent with the known actions of IL-12.
- There is evidence of GEN-1 activity on T-cell numbers as well as T-cell function. A dose-dependent increase in IFN-gamma, a strong mediator of immune response, following the treatment is impressive. Significant reduction in angiogenic growth factor, VEGF, is also a good indicator of the IL-12 treatment effect.
- The decrease in immune suppressive signals and the increase in the ratio of cytotoxic CD8+ cells to immune suppressive signals suggest a shift in tumor environment in favor of immune stimulation. A highly immune suppressive tumor environment is linked with a worsening of the disease and poor treatment outcome. A shift in the tumor microenvironment in favor of immune stimulation following GEN-1 treatment is a positive indication of the IL-12 treatment effect.
- The modulation of tumor microenvironment in favor of immune stimulation by GEN-1 raises its potential combination benefits with other forms of immunotherapies, especially adoptive T-cell therapy. GEN-1 pre-treatment has potential to improve the survival and potency of the engineered T-cells, a major limitation in adoptive T-cell therapies.
About the OVATION Study
The Phase Ib trial was designed to evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments
in total, with interval debulking surgery to follow. The regimen was primarily evaluated for its safety and tolerability. GEN-1, designed using
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