On February 13, 2017 Transgene (Paris:TNG), a company focused on designing and developing viral-based immune-targeted therapies for the treatment of cancers and infectious diseases, reported that the 1st patient in the ISI-JX trial has been treated at the Léon Bérard Cancer Center in Lyon, France (Press release, Transgene, FEB 13, 2017, View Source [SID1234517711]). ISI-JX is a Phase 1 clinical trial evaluating the intra-tumoral co-administration of Pexa-Vec in combination with ipilimumab in solid tumors (NCT02977156). This investigator initiated trial promoted by the Leon Bérard Cancer Center will enroll patients with metastatic and/or locally advanced solid tumors. Schedule your 30 min Free 1stOncology Demo! The open-label trial that will recruit up to 60 patients in several clinical centers in France. First readouts could be expected towards the end of 2017. The trial will evaluate the safety of the combination and evaluate the first signals for efficacy.
Pexa-Vec is a GM-CSF expressing vaccinia derived oncolytic virus co-developed by Transgene and SillaJen. Ipilimumab is a monoclonal antibody targeted against the immune checkpoint CTLA-4 and is currently approved for the treatment of melanoma (Yervoy, Bristol-Myers Squibb).
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!
Dr Aurélien Marabelle MD, PhD, from Gustave Roussy, a world expert in immunotherapy clinical research and coordinating investigator of the study commented: "We believe in the synergistic potential of the combination between oncolytic viruses and immune checkpoint-targeted antibodies. Also, we believe that the intra-tumoral co-delivery of these immunotherapies will trigger a better priming of the anti-tumor immune response while avoiding off-target toxicities. We hope this novel "in situ immunization" strategy will overcome the resistance to cancer immunotherapy that we observe in many patients."
The combination of Pexa-Vec and ipilimumab aims at targeting two distinct steps in the immune response against cancer cells and is expected to be significantly more effective than either product alone. Pexa-Vec is an oncolytic virus designed to (i) selectively destroy cancer cells through the direct lysis (breakdown) of cancer cells via viral replication, (ii) reduce the blood supply to tumors through vascular disruption, and (iii) stimulate the body’s immune response against cancer cells. Its mechanism of action and its safety profile make it an appropriate candidate for combinations with immune checkpoint inhibitors (ICIs) such as ipilimumab, which acts as a brake on the body’s immune response to cancer cells thereby potentially improving Pexa-Vec’s anti-cancer effects.
Maud Brandely, Chief Medical Officer of Transgene, said: "This trial aims to first demonstrate that the regimen of our oncolytic virus Pexa-Vec plus ipilimumab is well tolerated. We expect that the intra-tumoral administration of ipilimumab will have less systemic toxicity thanks to its local administration. Another objective is to show the antitumor activity of the regimen in patients with advanced solid tumors which have exhausted all standard therapeutic options."