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MDx/CDx Focus: MolecularMD Gains Exclusive Rights to Develop DDR2 Tests; NeoGenomics' MDS Tests


With Exclusive Rights, MolecularMD Developing Dx to Advance Squamous Cell Lung Cancer Treatments

MolecularMD has garnered exclusive rights from the Broad Institute and Dana Farber Cancer Institute to commercialize predictive and prognostic squamous cell lung cancer tests that gauge mutations in the DDR2 gene.

The inventors on the pending patents are Matthew Meyerson, Peter Hammerman, and Alexis Ramos.

"MolecularMD is developing DDR2 diagnostic assays, including next-generation sequencing tests, for clinical trials exploring efficacy of targeted therapies and DDR2 clinical utility," the company said in a statement. The company said it will "support commercialization of DDR2 technology through sublicensing to clinical reference laboratories and diagnostic assay developers and manufacturers."

While there are multiple genetic drivers for non-small cell lung cancer, such as EGFR, ALK, and MET, these markers aren't useful drug targets in squamous cell lung cancer. Mutations in DDR2 have been associated with approximately 4 percent of squamous cell lung cancer cases. The DDR2 kinase is involved in cell adhesion, proliferation, and migration.

In a 2011 paper in Cancer Discovery, researchers from Dana Farber reported that Sprycel (dasatinib) killed squamous cell lung cancer cell lines harboring DDR2 mutations. The drug seemed to block the cellular mechanisms that were triggered by expression of DDR2 mutations. In the same paper, researchers led by Hammerman, reported that a squamous cell lung cancer patient with a DDR2 mutation but now detectable EGFR mutation responded to the combination of Sprycel and Tarceva (erlotinib).

"These data suggest that gain-of-function mutations in DDR2 are important oncogenic events and are amenable to therapy with dasatinib," the study authors wrote. Sprycel is currently approved for the treatment of different types of leukemias.

According to MolecularMD, the published literature also suggests that other marketed tyrosine kinase inhibitors may also be able to target DDR2 mutations, including Gleevec (imatinib), Tasigna (nilotinib), and Iclusig (ponatinib)

Greg Cox, MolecularMD's director of licensing, characterized DDR2 as potentially "the first actionable biomarker" for squamous cell lung cancer patients. Cox added that MolecularMD hopes to support clinical trials examining treatments targeting this marker.

NeoGenomics Launches Myelodysplastic Syndrome Molecular Tests

NeoGenomics announced that it has validated and launched a suite of molecular tests that will enable "comprehensive profiling" of myelodysplastic syndrome.

According to the company, NeoGenomics' comprehensive MDS test gauges all the known disease-linked molecular mutations, including: SF3B1, U2AF1, SRSF2, ZRSR2, RUNX1, EZH2, ASXL1, TET2, TP53, NRAS, CBL, PTPN11, IDH1/2, and ETV6. The test can be used to confirm an MDS diagnosis, assess disease prognosis, help guide treatment strategies, or monitor response, the company said.

Each year in the US, approximately 10,000 people are diagnosed with MDS, a heterogenous hematological disease that can arise on its own or be caused by exposure to chemicals, chemotherapy, or radiation therapy.