DALLAS, Dec. 19, 2016 /PRNewswire/ -- Gradalis, Inc. a clinical stage cellular immunotherapy company, developing Vigil® Engineered Autologous Tumor Cell (EATC) therapy, today announced the establishment of a research alliance with the Icahn School of Medicine at Mount Sinai to advance the scientific understanding of Vigil EATC treatment. Under the terms of the agreement, Gradalis will provide funding and clinical samples for research to understand the nature of immune response generated to the Vigil engineered autologous tumor cell therapy.
The research collaboration will be jointly headed by Gradalis' Chief Scientific Officer, John Nemunaitis, MD, and by Seunghee Kim-Schulze, PhD, Assistant Professor of Medicine and Facility Director, Human Immune Monitoring Core at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai.
"We are extremely pleased to collaborate with the world class Immune Monitoring program at Mount Sinai," said Sunil Joshi, President and Chief Executive Officer of Gradalis. "This research collaboration will help us elucidate further the robust ELISPOT response observed in the Vigil EATC clinical trials, and characterize the nature of the immune response."
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"We are pleased to collaborate on this important project with Gradalis," said Miriam Merad, Professor of Oncological Science, Medicine (Hem/Onc Division) and Immunology, The Tisch Cancer and Precision Immunology Institutes at the Icahn School of Medicine at Mount Sinai. "Over the last few years, we have invested heavily in the latest technology to assist companies like Gradalis develop a deeper understanding of the immune mechanisms underlying their technologies. We look forward to leveraging our collective experience in helping Gradalis better understand the nature of the immune response generated to Vigil EATC."
This collaboration will span multiple clinical trials including the recently completed First in Human study and Ovarian Phase 2A study. Additional collaboration effort may be initiated to support ongoing registrational clinical trials in Ewing's sarcoma and ovarian cancer, as well as trials exploring the combination of Vigil and PD-1/PDL-1 inhibitors in non-small cell lung cancer (NSCLC), melanoma and triple negative breast cancer.
About Vigil EATC
Vigil is an investigational cellular immunotherapy technology that combines the concepts of genetic engineering with the science of immuno-oncology to enable an immune response to cancer cells. A patient's tumor cells are engineered with a plasmid carrying the gene vector for shRNA Furin and GMCSF to elicit a systemic T-cell directed immune response when administered to the patient through intradermal injections. By utilizing the patient's own tumor as the antigen source, Vigil EATC is designed to elicit an immune response that is specifically targeted and broadly relevant to each patient's unique tumor antigens. Vigil EATC is being studied in Ewing's sarcoma and ovarian cancer as a single agent, and in breast cancer, non-small cell lung cancer and melanoma in combination with PD-L1 inhibitors. More information about these studies can be found on www.vigilclinicaltrials.com.
