Transgene SA, Lee's Pharmaceutical and SillaJen have unveiled their late-stage clinical development plan for Pexa-Vec 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.
Dr. Eun-Sang Moon, CEO of SillaJen, Inc. 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 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."
Philippe Archinard, Chairman and Chief Executive Officer of Transgene, said, "Together with SillaJen and our other partners, we are pleased to be moving forward our joint development plan for Pexa-Vec. Pexa-Vec is an oncolytic immunotherapy with therapeutic potential, we believe, in several hard-to-treat cancers. In addition to moving the program into Phase 3 testing in liver cancer, for which today there is only one approved product, we will be exploring its potential in other cancer types and in combination with other therapies, such as immune checkpoint inhibitors."
Dr. Benjamin Li, Chief Executive Officer of Lee's Pharmaceutical, said, "China has the highest prevalence in liver cancer (HCC) in the world and despite recent advancement in targeted therapy, significant medical need remains unmet. Pexa-Vec's oncolytic immunotherapy approach has been shown in a previous Phase 2 study as a promising first line treatment option for advanced liver cancer patients. We look forward to starting the Phase 3 clinical trial with our partners in 2015 to validate the potential of this exciting agent and work towards a better management of advanced HCC in China."
To date, over 300 patients have been treated with Pexa-Vec. Additional data supporting the activity of Pexa-Vec across different tumor types is expected to be presented at upcoming medical conferences later this year.
Dr. Tae-Ho Hwang, SillaJen co-founder and Chief Scientific Officer commented, "We anticipate a number of these early exploratory studies will be performed in collaboration with Pusan National University Yangsan Hospital (PNUYH). The excellent team at PNUYH has been very supportive of the Pexa-Vec program and has demonstrated an ability to enroll patients quickly and conduct studies efficiently. We believe open collaboration and innovation by both the Company and Hospital is very important to lead promising immunotherapeutics such as Pexa-Vec to the clinic and we look forward to building on this progress as we move forward."
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