Merck, MDxHealth expand collaboration
IRVINE, Calif.—MDxHealth SA and Merck KGaA have announced an expansion of their previous collaboration. The expanded partnership will cover the development and worldwide commercialization of MDxHealth's MGMT (methylguanine-DNA methyltransferase) diagnostic test (PredictMDxTM for Glioblastoma), which has the potneitla to help identify glioblastoma patients who are more likely to benefit from cilengitide-based therapies that are currently being investigated, in combination with temozolomide and radiotherapy.
"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," Dr. Annalisa Jenkins, head of global drug development and medical for Merck Serono, said in a press release. "We are hoping that this will help to improve the future treatment of patients with glioblastoma, a disease which today has high unmet medical needs."
Cilengitide is a cancer drug candidate of Merck's currently undergoing Phase III development for newly diagnosed glioblastoma. The drug candidate is part of a class of investigational anti-cancer therapies known as integrin inhibitors, and is also being investigated as a potential treatment for non-small cell lung cancer, effects that are currently in Phase I/II development. Under the expanded collaboration, Merck will support MDxHealth's development and regulatory activities for the MGMT diagnostic test, and, once the test secures regulatory approval, a coordinated launch of MGMT together with cilengitide in glioblastoma. Financial details were not disclosed.
"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," Dr. Jan Groen, CEO of MDxHealth, said in a press release. "Today, we are excited to be partnering with Merck, one of the most advanced pharmaceutical companies in the field of personalized medicine."
MDxHealth and Merck KGaA first began working together in 2008, when their collaboration began with a Phase III trial. An extension of the companies' collaboration, which was originally centered on the use of the MGMT diagnostic assay in Merck's brain cancer trials, was announced in June 2011. MDxHealth's Predict MDx for Glioblastoma test has already seen use for the identification and stratification of patients newly diagnosed with glioblastoma and enrolled in cilengitide clinical studies who may benefit from a combination treatment with temozolomide, radiotherapy and cilengitide.
The test determines the methylation status of the methylguanine-DNA methyltransferase (MGMT) gene promoter, a gene thought to play a part in cellular DNA repair. When the MGMT gene is methylated, it is no longer expressed in normal amounts, which can lead to an increased responsiveness of tumor cells to some chemotherapy regimens.
"We are proud to expand our existing partnership with MDxHealth, sharing complementary skills and capabilities in the field of personalized medicine with the common passion to get new therapies to patients who need them," Dr. Susan Jane Herbert, head of global business development and strategy at Merck Serono, said in a press release.