TRANSGENE SIGNS AN AGREEMENT WITH VENTANA MEDICAL SYSTEMS, INC. TO DEVELOP A COMPANION DIAGNOSTIC TEST
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Parc d?Innovation d?Illkirch, France, September 29, 2010 ? Transgene (Euronext Paris: FR0005175080) and Ventana Medical Systems, Inc. today announced that they have entered into a collaboration agreement for the development of an immunohistochemistry (IHC) assay, as a companion diagnostic test for TG4010, Transgene?s immunotherapy product.
TG4010 is about to enter into a Phase IIb/III clinical trial in advanced non-small cell lung cancer (NSCLC) patients with tumor cells expressing the MUC1 protein. A MUC1 IHC assay will initially be developed by Ventana to identify MUC1 positive tumor cells, as a diagnostic test for selecting patients to be enrolled in the upcoming Phase IIb/III trial.
In the event of successful completion of TG4010?s clinical development, a New Drug Application (NDA) will be submitted by Transgene or its licensee, and Ventana will submit in parallel the companion MUC1 IHC test for Pre-market Approval (PMA) in the United States as a class III in vitro diagnostic device, a classification under the FDA regulation for companion diagnostic tests used for screening patients? eligibility for drugs. If regulatory approvals are granted, the MUC1 companion diagnostic IHC test will serve as a tool for physicians to identify patients who can be treated with TG4010.
Philippe Archinard, Chief Executive Officer and President of Transgene, said: ?Ventana is the IHC market leader and is also committed to become a leader in the development of companion diagnostic tests. We are very pleased to partner with them so as to further develop a MUC1 IHC assay for TG4010. Development of such a test is critical for the product?s entry into late stage clinical development, as well as for its future commercialization.?
Doug Ward, Vice President of Translational Diagnostics for Ventana, said: ?We are very excited to participate in the Phase IIb/III trial of Transgene?s TG4010 immunotherapeutic product by developing a companion diagnostic to select patients. The development of a companion diagnostic assay at this critical stage further demonstrates our commitment to deliver personalized healthcare. At Ventana, we are committed to working with biopharmaceutical companies like Transgene to effectively tailor therapies for patients in order to better manage diseases such as non-small cell lung cancer.?
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