NEW YORK (GenomeWeb News) – Ariad Pharmaceuticals and MolecularMD today announced a collaboration under which MolecularMD will develop a companion diagnostic test to identify the T315I mutation of the BCR-ABL gene in patients with chronic myeloid leukemia and Philadelphia-positive acute lymphoblastic leukemia.
Ariad is developing its investigational pan-BCR-ABL inhibitor, ponatinib, in a pivotal trial of patients with resistant or intolerant CML and Ph+ ALL, or with the T315I mutation. MolecularMD has done BCR-ABL mutation testing with its standardized and validated sequencing test in patients enrolled in Ariad's earlier Phase 1 trial of ponatinib and is currently engaged in testing patients prior to treatment in the latest study.
The Portland, Ore.-based molecular diagnostic products and services firm will optimize its current test and file and for pre-market approval with the US Food and Drug Administration for the test. MolecularMD is expected to do so concurrently with Ariad's new drug application for ponatinib in 2012.
MolecularMD also will pursue CE marking for the test in Europe, and will be responsible for commercialization of the T315I diagnostic test.
The companion diagnostic is being developed to identify CML and Ph+ ALL patients with the T315I mutation. Such a test is not needed for the broader potential use of ponatinib in patients who are resistant to or intolerant of the current second generation of BCR-ABL, inhibitors MolecularMD and Ariad said. Mutations other than T315I mutation are responsible for currently marketed BCR-ABL inhibitors, they added.
Under the terms of the deal, Cambridge, Mass.-based Ariad will reimburse MolecularMD for predefined expenses for the development of the T315I test. MolecularMD also will receive certain milestone payments related to development and regulatory activities.