Date: 2012-07-05

Type of information: Development agreement

Compound: PredictMDx for BrainTM (MGMT assay)

Company: MDX Health (Belgium) Merck KGaA, Merck Serono (Germany)

Therapeutic area: Cancer - Oncology

Type agreement:


Action mechanism:

PredictMDx for Brain is a test for predicting patient response to alkylating agents, a class of chemotherapy drugs. The test assesses the methylation status of the MGMT gene, which is correlated with response to drug therapy. The MGMT gene is a crucial DNA repair gene. MDxHealth PredictMDx for Brain test determines the methylation status of the MGMT gene in tumor tissue, andMDxHealth's PredictMDx for Glioblastoma test assesses the methylation status of the methylguanine-DNA methyltransferase (MGMT) gene promoter. The MGMT gene is thought to contribute to cellular DNA repair; and, when the gene is methylated, it is no longer expressed in normal amounts leading to a proposed increased responsiveness of tumor cells to some chemotherapeutic regimens.

Disease: brain cancer (glioblastoma)


* On June 9, 2011, MDxHealth, a belgian molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, and Merck KGaA have announced that they will extend their agreement for use of MDxHealth's MGMT assay in Merck KGaA's brain cancer clinical trials.  Merck KGaA's is currently investigating its integrin inhibitor cilengitide in a Phase III trial (CENTRIC) in newly diagnosed patients with glioblastoma with a methylated promoter of the methylguanine-DNA methyltransferase (MGMT) gene in the tumor tissue.
Prior to patient enrollment in CENTRIC, MGMT gene promoter testing performed at the laboratories of MDxHealth is required. CENTRIC is the first prospective international controlled Phase III oncology trial that uses the MGMT assay as a standard to determine the patient population for a trial.
With the new agreement the partners are continuing their collaboration that started with the pivotal Phase III CENTRIC trial initiated in 2008. Merck KGaA is also conducting the CORE trial, which is a randomized controlled Phase II study with cilengitide in newly diagnosed glioblastoma patients. As in the CENTRIC trial, the CORE trial will rely on MDxHealth's MGMT gene promoter methylation assay for the stratification of patients. However, while patients enrolled in the CENTRIC trial require a positive methylation status of the MGMT promoter in the tumor, patients in the CORE trial require an unmethylated status of the MGMT gene promoter.

Financial terms:

Financial terms of the agreement are not disclosed.

Latest news:

* On July 5, 2012, MDxHealth has announced that it  has expanded its collaboration with Merck KGaA. This expanded collaboration covers the development and worldwide commercialization of MDxHealth’s MGMT (methylguanine-DNA methyltransferase) diagnostic test (PredictMDxTM for Glioblastoma), which might help to identify those glioblastoma patients who might be more likely to benefit from cilengitide-based therapies that are currently under investigation, in combination with temozolomide and radiotherapy. As part of the expanded collaboration, Merck has agreed to support MDxHealth’s development and regulatory activities for the MGMT test and, after regulatory approval, the coordinated launch together with cilengitide in glioblastoma.
“With this agreement, MDxHealth and Merck are collaborating to bring PredictMDx for Glioblastoma to the clinical community – as a companion diagnostic in the US if approved by FDA, and as a validated assay in other regions of the world – enabling personalized treatment of newly diagnosed glioblastoma patients. ” said Dr. Jan Groen, CEO of MDxHealth.
“Our collaboration with MDxHealth reflects the importance of diagnostics in the field of personalizing cancer care, an approach that Merck Serono is actively investing in with the ultimate goal to identify those patients who are most likely to benefit from a certain treatment through the use of a biomarker-guided approach,” said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for Merck Serono.

Is general: Yes