company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene, a bio-pharmaceutical company specialized in the development of immunotherapeutic products, today announced that they have entered into an exclusive partnership to develop and commercialize JX-594 for the treatment of solid tumours in Europe, the Commonwealth of Independent States (CIS) and the Middle East.JX-594, Jennerex’s lead cancer biotherapeutic
product, has shown anticancer activity and a well-tolerated safety profile in Phase 1 and Phase 2 clinical trials to date. Objective tumour response has been demonstrated in a variety of cancers including liver, colon, kidney, lung and melanoma.Jennerex has awarded Transgene exclusive rights to develop and commercialize JX-594 in Europe, the CIS and the Middle East. Jennerex and Transgene will co-develop JX-594 worldwide, with Transgene responsible for development costs and for clinical development in its licensed territories, pursuant to the JX-594 global development plan. Transgene is responsible for commercialization and has the right to manufacture JX-594 in the Transgene
territory. As part of this agreement Transgene has made an upfront equity investment in Jennerex. Jennerex is further eligible to earn a total of up to $116 million in development and registration milestones as well as double digit royalties on a tiered structure. In addition, Jennerex has an option for co-promotion and profit-sharing in the five major European countries.The development plan will focus initially on Hepatocellular Carcinoma (HCC), both in first line and in second line, and on colorectal cancer. Transgene and Jennerex intend to initiate a large randomized controlled phase 2b/3 clinical program in HCC patients. A Phase 2 study in colorectal cancer patients who are refractory or intolerant to Erbitux is planned as well.
“We are extremely pleased to have such a strong collaborative partner for JX-594. Transgene is an ideal partner for this product given their expertise in oncology and in the development of virus-based immunotherapeutic products. We look forward to working together with our new partners to realize the full potential of this innovative product,” stated David H. Kirn, M.D., President and Chief Executive Officer of Jennerex. “We believe that JX-594 has the potential to significantly improve and prolong the lives of patients with liver, colorectal, and other types of cancer based on its clinical profile to date. By applying Transgene’s depth of knowledge and experience in the development of immunotherapies, as well as its established relationships with European regulatory authorities, we believe that we can achieve JX-594 marketability more quickly.”
Philippe Archinard, Chairman and Chief Executive Officer of Transgene stated: “We are enthusiastic about our partnership with Jennerex on JX-594—a product that has shown promising anti-cancer activity to date in patients. This partnership agreement fits perfectly our three pillar based development strategy and is an exciting addition to our pipeline of immunotherapy products, further contributing to its maturity. With a time to market in Europe forecast for 2015 and a European market potential of over $1bn, JX-594 has the capacity to provide us with a very substantial return on our investment, should the product meet all of its milestones. From a financial perspective, this investment in JX-594 is included in our five year plan and is consistent with our goal to market our first product by 2015 without additional fund raising. Together with Jennerex, we will work to advance JX-594 in order to offer this important new treatment option to cancer patients in Europe and surrounding countries.”
JX-594 is a proprietary, engineered oncolytic virus that is designed to selectively target and destroy cancer cells. JX-594 is designed to attack cancer through three diverse mechanisms of action: the lysis of cancer cells through viral replication, the reduction of the blood supply to tumors through vascular targeting and destruction, and the stimulation of the body's immune response against cancer cells. Phase 1 and Phase 2 clinical trials in multiple cancer types to date have shown that JX-594, delivered either directly into tumors or systemically, induces tumor shrinkage and/or necrosis and is well-tolerated by patients. Objective tumor response has been demonstrated in a variety of cancers including liver, colon, kidney, lung and melanoma.
Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third most common cause of cancer-related deaths world-wide with about 660,000 patients dying from the disease annually. Most HCC cases develop on the background of chronic liver cirrhosis; in regions with the highest incidence of HCC, East Asian and African countries, the majority of cases are related to hepatitis B; in developed Western countries and Japan the disease is commonly related to hepatitis C, heavy alcohol consumption and non-alcoholic fatty liver due to metabolic syndromes such as diabetes and obesity. There is accumulating evidence that the incidence of HCC is increasing in Western countries. Despite recent advances, the treatment of advanced HCC remains a significant unmet medical need with a median expected survival under current therapies of less than one year.
Jennerex Inc
