Transgene is using two companion tests, one being developed by Beckman Coulter and another by Ventana Medical Systems, to pick best responders to its investigational non-small cell lung cancer drug TG4010.
The immunohistochemistry test developed by Ventana will allow Transgene to identify patients expressing mucin 1-positive tumor cells in clinical trials. TG4010 was designed to target MUC1, and the IHC assay will be used to select patients to be enrolled in an upcoming Phase IIb/III trial for the drug.
The test developed by Beckman Coulter will measure levels of triple positive activated natural killer, or aNK, cells. Earlier studies involving TG4010 suggested that the drug was "well tolerated" and extended survival "in a subset of patients with a normal level of aNK cells in the blood at baseline," Transgene said in a statement.
The drug, an MVA-MUC1-IL2 immunotherapeutic, will enter the Phase IIb/III trial this year, at which point Transgene plans to use the two companion tests to analyze which subpopulations of patients with advanced NSCLC will likely respond best to TG4010 in combination with first-line therapy.
"If the trial is successful and regulatory approvals are granted for TG4010 and for the tests, these companion tests could then serve as a tool for physicians to identify patients who can be treated with TG4010 upon commercialization," Transgene said in a statement. According to the company, it has begun discussions with both the drug and device divisions of the US Food and Drug Administration.
As the development program for TG4010 progresses, it's worth noting that Novartis holds an option to acquire an exclusive worldwide license for the development and commercialization of the drug. Under the terms of the deal, if Novartis exercises this option, Transgene will maintain co-promotion rights in certain countries, as well as manufacturing rights.
Patient recruitment for the Phase IIb/III for TG4010 in NSCLC is slated to start midyear.