Transgene, Lee's Pharma and SillaJen confirm clinical development plan for Pexa-Vec

France’s Transgene (NYSE-Euronext: TNG), Hong Kong-based Lee’s Pharmaceutical (HKEx: 0950) and South Korea’s SillaJen have unveiled their late-stage clinical development plan for Pexa-Vec (JX-594/TG6006) oncolytic immunotherapy.

The companies plan to initiate a global Phase III study in the first-line treatment of advanced hepatocellular carcinoma (HCC, liver cancer) patients, as well as several additional Phase I/II 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.

Eun-Sang Moon, chief executive of SillaJen, which acquired rights to the product with its buy of USA-based Jennerex (The Pharma Letter November 27, 2013), said: “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 II 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 IIb, as published in Nature Medicine."