NEW YORK (GenomeWeb News) – French biopharmaceutical firm Transgene today announced Beckman Coulter will develop a companion diagnostic for Transgene to measure levels of activated Natural Killer (aKN) cells so that patients can be selected for treatment with an immunotherapy candidate for non-small cell lung cancer.
Beckman Coulter will develop the test to measure triple positive — CD16+, CD56+, CD69+/CD45+ lymphocytes — aNK cells to identify patients who may be suitable for treatment with TG4010, an MVA-MUC1-IL2 immunotherapy candidate that is about to enter a Phase IIb/III clinical trial.
Financial and other terms of the agreement were not disclosed.
Transgene said in a statement that findings from the most recent clinical trial indicated TG4010 was well tolerated and extended life expectancy in a subset of patients with a normal level of aNK cells in the blood at baseline.
Separately, Ventana Medical Systems is developing a test for Transgene for the identification of patients with MUC1-positive tumor cells. The test being developed by Beckman Coulter, as well as Ventana's test, will be used in the upcoming clinical trial, which is expected to start recruitment in the middle of the year.
If Transgene is successful in commercializing them, "these companion tests could then serve as a tool for physicians to identify patients who can be treated with TG4010 upon commercialization," the company said.
The company added that it is progressing in discussions with the US Food and Drug Administration's Center for Devices and Radiological health and the agency's Center for Biologics Evaluation and Research regarding the drug.
Transgene has granted Novartis an exclusive worldwide license to develop and commercialize TG4010.