MolecularMD Corp, a developer and provider of cancer-based pharmacogenomic diagnostic tests, announced  that it has granted a sub-license agreement for the detection of ABL kinase mutations in Chronic Myelogenous Leukemia (CML) patients to Mayo Foundation for Medical Education and Research (Mayo Clinic).

Approximately 26,000 people live with CML in the US, with about 5,000 new patients being diagnosed each year. The leukemia is associated with the formation of the BCR-ABL oncogene as a result of a chromosomal translocation known as the Philadelphia Chromosome (Ph).

The advent of targeted tyrosine kinase inhibitors (TKIs) such as Gleevec® (Novartis) and Sprycel® (Bristol Meyer Squibb) has revolutionized the treatment of Ph+ CML. However, a small proportion of patients develop acquired secondary drug resistance via point mutations in the ABL kinase domain. These ABL kinase mutations can interfere with the binding of TKIs to the targeted BCR-ABL oncoprotein which can lead to disease progression from chronic phase to accelerated or blast phase.

The T315I ABL mutation is of particular interest to drug development companies as it has manifested complete resistance to all current kinase inhibitors drugs indicated for CML.

Hematology/Oncology physicians at Mayo Clinic treat chronic myeloid leukemia (CML) patients at each of their three campuses in Arizona, Florida and Minnesota. ABL kinase domain mutation analysis is most often performed in high complexity molecular diagnostic laboratories, which also typically provide broad expertise in the molecular diagnosis and monitoring of CML patients.

This sub-license will allow Mayo Clinic to add ABL kinase domain mutation testing to the current range of BCR-ABL analyses in the Molecular Hematopathology Laboratory, thus providing critical information to clinicians about possible drug resistance in CML patients receiving tyrosine kinase inhibitor (TKI) therapy. The ability to offer ABL kinase domain mutation testing will therefore help guide Mayo physicians regarding the best course of treatment for these patients.

The intellectual property for the sub-license is based on USPTO Patent # 7326534 owned by Oregon Health & Science University (OHSU). MolecularMD was granted a license in 2007 for the exclusive commercial rights of the patented mutation discoveries made by Drs. Brian Druker and Amie Corbin at OHSU.

Source: MolecularMD Corp