MDxHealth’s epigenetic MGMT test will be used during recruitment of a randomized, double-blind Phase III global clinical study of Celldex’s immunotherapeutic vaccine, rindopepimut, in newly diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. The study has begun screening patients. Financial terms of the deal were not disclosed.  

 

Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor specific molecule called EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR).  

 

“In clinical trials, epigenetic analysis provides vital information for patient selection and recruitment,” says Dr. Jan Groen, CEO of MDxHealth. “Our epigenetic MGMT test is now being used by our pharmaceutical partners in several clinical studies, including Celldex, demonstrating growing industry interest in our epigenetic tests and technology.”  

 

Groen points out that MDxHealth’s epigenetic MGMT test is able to determine the methylation status of the MGMT promoter gene in glioblastoma patients, thereby helping to stratify the patient population for the study.  

 

Brad Miles, a spokesman for Celldex, says MDxHealth proved to be the right collaborator for the agreement because of its experience with the epigenetic MGMT prognostic assay.

 

“This test identifies one factor connected to sensitivity or resistance to the chemotherapy temozolomide, which is the standard of care for patients with newly diagnosed glioblastoma,” says Miles. “The test will be used to stratify sensitive and resistant patients on each arm of the randomized study, assuring that there is an equal balance for prognosis on both arms.”  

 

The Phase III rindopepimut study is expected to enroll up to 440 patients to recruit 374 patients with newly diagnosed EGFRvIII-expressing GBM following gross total resection at more than 150 clinical sites internationally.

 

In the study, patients expressing EGFRvIII will be tested with the epigenetic MGMT prognostic assay to determine methylation status of the MGMT promoter gene. The MGMT methylation result will be used to ensure that the two arms of the clinical trial are balanced for the known prognostic influence of improved overall survival in MGM- methylated individuals.

 

“Patients with glioblastoma whose tumors are positive for MGMT gene promoter methylation have demonstrated improved overall survival and improved progression-free survival when compared to patients with unmethylated or normally functioning MGMT,” Groen notes. “The measure of success will be positive results from the rindopepimut study. Several biomarkers will be measured prior to the patient receiving therapy, so providing timely assay results is essential.”  

 

Miles notes that the data from previous studies on rindopepimut are very promising. “If the benefit seen against historical controls is again seen in the randomized study, rindopepimut will be a very important treatment for these patients,” he says. “If the assay is done rapidly and accurately under this contract, we will be likely to have a positive study.”