French firm Transgene has made an equity investment in Jennerex as part of an exclusive partnership agreement to develop and commercialize the latter’s clinical-stage oncolytic virus-based candidate JX-594 in Europe, the Commonwealth of Independent States (CIS), and the Middle East. The deal gives Transgene exclusive rights to JX-594 in the named territories, while the firms will partner development of the candidate in all other regions worldwide. Transgene will shoulder development costs and carry out clinical development in its licensed countries. Jennerex could receive up to $116 million in development and registration milestones and has an option to co-promote and profit-share JX-594 in the five major European countries.
The initial focus will be development of JX-594 for hepatocellular carcinoma (HCC) and colorectal cancer. To this end the firms say they plan to start both a Phase IIb/III clinical trial in HCC patients and a Phase II study in colorectal cancer patients who are refractory or intolerant to Erbitux® therapy. JX-594 is also in early-stage clinical trials against melanoma, head and neck cancer, and lung cancer.
“This partnership agreement fits perfectly with our three pillar based development strategy and is an exciting addition to our pipeline of immunotherapy products,” remarks Philippe Archinard, Transgene chairman and CEO. “With a time to market in Europe forecast for 2015 and a European market potential of over $1billion, JX-594 has the capacity to provide us with a very substantial return on our investment should the product meet all of its milestones.”
JX-594 is a modified vaccinia virus that has been engineered to remove its thymidine kinase and armed with the GM-CSF gene to stimulate systemic antitumoral immune response in the context of product replication and lysis of the infected cancer cells, Jennerex claims. The firm says trials to date have confirmed that both intratumoral administration and systemic delivery of JX-594 induce tumor shrinkage and/or necrosis.