One-two punch

Jennerex, Transgene forge partnership to co-develop cancer-fighting virus JX-594

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SAN FRANCISCO—French biotech firm Transgene SA and U.S.-basedcancer drug developer Jennerex Inc. recently announced they are forging apartnership to develop and sell an experimental treatment that targets andkills cancer cells in Europe, Russia and the Middle East. 
The companies plan to co-develop Jennerex's JX-594, acancer-fighting virus that has shown objective tumor response in a variety ofcancers including liver, colon, kidney, lung and melanoma.
Under terms of the agreement, Illkirch, France-basedTransgene has taken an equity stake in Jennerex, which could earn up to $116million in milestone payments and double-digit royalties under the arrangement.Jennerex also has an option for co-promotion and profit-sharing in the fivemajor European countries and retains U.S. rights to the drug.
Gregory Schafer, senior vice president and chief financialofficer of Jennerex, says this is the first time the companies have workedtogether, and his firm is extremely pleased to have such a strong collaborativepartner for JX-594. 
"Transgene is an ideal partner for this product given theirexpertise in oncology and in the development of virus-based immunotherapeuticproducts," he says. "We look forward to working together with our new partnersto realize the full potential of this innovative product."
Schafer adds that he believes Transgene "will be a committedand motivated partner given their focus, development expertise and capabilitiesin viral immunotherapies for cancer."
"By applying Transgene's depth of knowledge and experiencein the development of immunotherapies, as well as its established relationshipswith European regulatory authorities, we believe that we can achieve JX-594marketability more quickly," adds Jennerex CEO David Kirn.
The development plan will focus initially on hepatocellularcarcinoma (HCC), both in first line and in second line, and on colorectalcancer. Transgene and Jennerex intend to initiate a large randomized controlledPhase IIb/III clinical program in HCC patients. A Phase III study in colorectalcancer patients who are refractory or intolerant to Erbitux is planned as well.
"With a time to market in Europe forecast for 2015 and aEuropean market potential of over $1 billion, JX-594 has the capacity toprovide us with a very substantial return on our investment, should the productmeet all of its milestones," Transgene CEO Philippe Archinard says.
Archinard adds that the partnership agreement fits perfectlywith Transgene's three-pillar development strategy and is an exciting additionto its pipeline of immunotherapy products, further contributing to itsmaturity.
"From a financial perspective, this investment in JX-594 isincluded in our five-year plan and is consistent with our goal to market ourfirst product by 2015 without additional fundraising," he notes. "Together withJennerex, we will work to advance JX-594 in order to offer this important newtreatment option to cancer patients in Europe and surrounding countries."
In development since 2004, Schafer explains that JX-594 is aproprietary, engineered oncolytic virus that is designed to selectively targetand destroy cancer cells.
JX-594 is designed to attack cancer through three diversemechanisms of action: the lysis of cancer cells through viral replication, thereduction of the blood supply to tumors through vascular targeting anddestruction and the stimulation of the body's immune response against cancercells. Phase I and Phase II clinical trials in multiple cancer types to datehave 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 cancersincluding liver, colon, kidney, lung and melanoma.
In its research efforts, Jennerex on Sept. 13 reported positiveinterim data from a pilot trial using JX-594 followed by sorafenib to treatliver cancer patients. The data were presented at the Fourth AnnualInternational Liver Cancer Association Conference in Montreal.
"While these data represent a small number of patients, weare encouraged by the results, particularly with regard to the promisingsurvival data when compared to historical controls and the fact that allpatients to date have exhibited disease control with the treatment regimen ofJX-594 followed by sorafenib, including patients whose tumors were previouslyresistant to sorafenib," Kirn points out. "We expect to report full resultsfrom this pilot trial next year and will evaluate the possibility of a larger,randomized clinical trial utilizing this treatment regimen at that time."
In August, Jennerex closed a private placement financing ofapproximately $8.6 million to primarily fund JX-594.
Schafer notes that in addition to offering tremendousoverall expertise in the development of immunotherapies, Transgene will offervery measurable benefit as it relates to the development, regulatory andcommercialization of JX-594 in Europe.
"We will measure success through our ability to worktogether to successfully conduct robust, global clinical trials to establishthe efficacy and safety profile of JX-594 in advanced liver and other cancers,"he says. "Ultimately, our success will be measured by our ability to servepatients through the potential commercialization of JX-594 globally."
Based in San Francisco, Jennerex is a clinical-stagebiotherapeutics company focused on the development and commercialization offirst-in-class, breakthrough targeted oncolytic products for cancer. Jennerexhas related research and development operations in Ottawa, Canada and Pusan,South Korea.
Transgene, a member of the Institut Mérieux Group, is apublicly traded French biopharmaceutical company dedicated to the developmentof therapeutic vaccines and immunotherapeutic products in oncology andinfectious diseases.

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