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SillJen, Transgene, and Lee's Pharmaceutical Unveil Late-Stage Development Plan for Pexa-Vec
Enrollment of Phase 3 study in first-line advanced liver cancer is expected to begin by mid-2015. The companies also plan to initiate several additional Phase 1/2 trials for different cancers during 2014.
Transgene SA, Lee’s Pharmaceutical, and SillaJen today unveiled their late-stage clinical development plan for Pexa-Vec (JX-594/TG6006) oncolytic immunotherapy. The companies plan to initiate a global Phase 3 study in the first-line treatment of advanced hepatocellular carcinoma (HCC, liver cancer) patients, as well as several additional Phase 1/2 trials in different cancers, both as a single agent and in combination with a variety of other treatments, including immunotherapies such as immune checkpoint inhibitors. In addition, the partners plan to undertake several exploratory trials of intravenous infusion therapy in various tumor types, including renal, breast and soft tissue sarcoma.
“With the recent closing of our acquisition of Jennerex, Inc., we are very excited to focus, together with Transgene and our other partners, on advancing and broadening the clinical development for Pexa-Vec, our innovative oncolytic immunotherapy.
We believe that this emerging multi-mechanistic therapeutic class holds great promise in treating patients with cancers for which today there are very limited treatment options. In a dose-finding Phase 2 study, Pexa-Vec has demonstrated clinical activity with IV delivery. High-dose Pexa-Vec was associated with longer survival benefit in first-line liver cancer patients in Phase 2b, as published in Nature Medicine."
Dr. Eun-Sang Moon, CEO of SillaJen, Inc. said:
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