LIEGE, Belgium—MDxHealth recently signed an agreement withCelldex Therapeutics for the use of its MGMT Epigenetic Test in a Phase IIIrindopepimut study of brain cancer.
MDxHealth's epigenetic MGMT test will be used duringrecruitment of a randomized, double-blind Phase III global clinical study ofCelldex's immunotherapeutic vaccine, rindopepimut, in newly diagnosedglioblastoma multiforme (GBM), an aggressive form of brain cancer. The studyhas begun screening patients. Financial terms of the deal were not disclosed.
Rindopepimut is an investigational immunotherapeutic vaccinethat targets the tumor specific molecule called EGFRvIII, a functional variantof the epidermal growth factor receptor (EGFR).
"In clinical trials, epigenetic analysis provides vitalinformation for patient selection and recruitment," says Dr. Jan Groen, CEO ofMDxHealth. "Our epigenetic MGMT test is now being used by our pharmaceuticalpartners in several clinical studies, including Celldex, demonstrating growingindustry interest in our epigenetic tests and technology."
Groen points out that MDxHealth's epigenetic MGMT test isable to determine the methylation status of the MGMT promoter gene inglioblastoma patients, thereby helping to stratify the patient population forthe study.
Brad Miles, a spokesman for Celldex, says MDxHealth provedto be the right collaborator for the agreement because of its experience withthe epigenetic MGMT prognostic assay.
"This test identifies one factor connected to sensitivity orresistance to the chemotherapy temozolomide, which is the standard of care forpatients with newly diagnosed glioblastoma," says Miles. "The test will be usedto stratify sensitive and resistant patients on each arm of the randomizedstudy, assuring that there is an equal balance for prognosis on both arms."
The Phase III rindopepimut study is expected to enroll up to440 patients to recruit 374 patients with newly diagnosed EGFRvIII-expressingGBM following gross total resection at more than 150 clinical sitesinternationally.
In the study, patients expressing EGFRvIII will be testedwith the epigenetic MGMT prognostic assay to determine methylation status ofthe MGMT promoter gene. The MGMT methylation result will be used to ensure thatthe two arms of the clinical trial are balanced for the known prognosticinfluence of improved overall survival in MGM- methylated individuals.
"Patients with glioblastoma whose tumors are positive forMGMT gene promoter methylation have demonstrated improved overall survival andimproved progression-free survival when compared to patients with unmethylatedor normally functioning MGMT," Groen notes. "The measure of success will be positiveresults from the rindopepimut study. Several biomarkers will be measured priorto the patient receiving therapy, so providing timely assay results isessential."
Miles notes that the data from previous studies onrindopepimut are very promising.
"If the benefit seen against historical controls is againseen in the randomized study, rindopepimut will be a very important treatmentfor these patients," he says. "If the assay is done rapidly and accuratelyunder this contract, we will be likely to have a positive study."