On January 19, 2017 Celsion Corporation reported that it will present two posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Clinical Immuno-Oncology Symposium being held from February 23 – 25, 2017 in Orlando, FL (Press release, Celsion, JAN 19, 2017, View Source [SID1234517449]). The symposium will focus on the latest clinical and translational research in immuno-oncology and the implications for clinical care. The first poster will report clinical results from the Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. The second poster will report translational data from the OVATION Study and previous GEN-1 clinical trials. The posters will be presented by Khursheed Anwer, Ph.D., Celsion’s executive vice president and chief science officer.
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Poster Presentation details:
Title: 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
Date and Time: Poster Session A – February 23, 2017 (11:30 am – 1:00 pm ET; 5:30 pm to 6:30 pm ET)
Poster Number: 155
Title: 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
Date and Time: Poster Session A – February 23, 2017 (11:30 am – 1:00 pm ET; 5:30 pm to 6:30 pm ET)
Poster Number: 156
"Our hypothesis is that GEN-1 plus neoadjuvant chemotherapy treatment will reprogram the tumor immune microenvironment towards a potent antitumor immune response," said Dr. Anwer. "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 (Free ASCO Whitepaper)-SITC symposium, and look forward to sharing the impressive clinical and translational results with the scientific community."
The OVATION Study is designed to enroll three to six patients per dose cohort with the goal of identifying a safe, tolerable and immunologically active dose of GEN-1 by recruiting and maximizing an immune response. Enrollment in the fourth cohort is ongoing with the goal of enrolling three additional patients in this final dose cohort. Celsion expects to complete enrollment in the OVATION Study this quarter and report final data, including translational data for all patients, in the second quarter of 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin and Doxil.