Merck, MDxHealth expand collaboration

IRVINE, Calif.—MDxHealth SA and Merck KGaA have announced anexpansion of their previous collaboration. The expanded partnership will coverthe development and worldwide commercialization of MDxHealth's MGMT(methylguanine-DNA methyltransferase) diagnostic test (PredictMDxTM forGlioblastoma), which has the potneitla to help identify glioblastoma patientswho are more likely to benefit from cilengitide-based therapies that arecurrently being investigated, in combination with temozolomide and radiotherapy.

"Our collaboration with MDxHealth reflects the importance ofdiagnostics in the field of personalizing cancer care, an approach that MerckSerono is actively investing in with the ultimate goal to identify thosepatients who are most likely to benefit from a certain treatment through theuse of a biomarker-guided approach," Dr. Annalisa Jenkins, head of global drugdevelopment and medical for Merck Serono, said in a press release. "We arehoping that this will help to improve the future treatment of patients withglioblastoma, a disease which today has high unmet medical needs."

Cilengitide is a cancer drug candidate of Merck's currentlyundergoing Phase III development for newly diagnosed glioblastoma. The drugcandidate is part of a class of investigational anti-cancer therapies known asintegrin inhibitors, and is also being investigated as a potential treatmentfor non-small cell lung cancer, effects that are currently in Phase I/IIdevelopment. Under the expanded collaboration, Merck will support MDxHealth'sdevelopment and regulatory activities for the MGMT diagnostic test, and, oncethe test secures regulatory approval, a coordinated launch of MGMT togetherwith cilengitide in glioblastoma. Financial details were not disclosed.

"With this agreement, MDxHealth and Merck are collaboratingto bring PredictMDx for Glioblastoma to the clinical community—as a companiondiagnostic in the US if approved by FDA, and as a validated assay in otherregions of the world—enabling personalized treatment of newly diagnosedglioblastoma patients," Dr. Jan Groen, CEO of MDxHealth, said in a pressrelease. "Today, we are excited to be partnering with Merck, one of the mostadvanced pharmaceutical companies in the field of personalized medicine."

MDxHealth and Merck KGaA first began working together in2008, when their collaboration began with a Phase III trial. An extension ofthe companies' collaboration, which was originally centered on the use of theMGMT diagnostic assay in Merck's brain cancer trials, was announced in June2011. MDxHealth's Predict MDx for Glioblastoma test has already seen use forthe identification and stratification of patients newly diagnosed withglioblastoma and enrolled in cilengitide clinical studies who may benefit froma combination treatment with temozolomide, radiotherapy and cilengitide.

The test determines the methylation status of themethylguanine-DNA methyltransferase (MGMT) gene promoter, a gene thought toplay a part in cellular DNA repair. When the MGMT gene is methylated, it is nolonger expressed in normal amounts, which can lead to an increasedresponsiveness of tumor cells to some chemotherapy regimens.

"We are proud to expand our existing partnership withMDxHealth, sharing complementary skills and capabilities in the field ofpersonalized medicine with the common passion to get new therapies to patientswho need them," Dr. Susan Jane Herbert, head of global business development andstrategy at Merck Serono, said in a press release.