MDxHealth Enters Agreement with Celldex for Use of MGMT Epigenetic Test in Phase III Rindopepimut Study in Brain Cancer

Regulatory News:

MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized cancer treatment, today announced that it has entered into an agreement with Celldex Therapeutics, Inc. (NASDAQ: CLDX). 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.

“In clinical trials, epigentic analysis provides vital information for patient selection and recruitment. 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,” explained Dr. Jan Groen, CEO of MDxHealth.

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 over 150 clinical sites internationally. Patients expressing EGFRvIII will be tested with MDxHealth’s 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 MGMT methylated individuals.

The use of MDxHealth's epigenetic MGMT assay is based on studies that have shown that epigenetic silencing of the MGMT gene promoter may help to identify brain tumors more likely to respond to standard chemotherapeutic agents. Following treatment, GBM patients 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.

About Rindopepimut

Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor specific molecule called EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR). EGFRvIII is a common mutated form of the natural EGFR and is present in multiple cancer types. Unlike EGFR, EGFRvIII has not been detected at a significant level in normal tissues, and it can directly lead to cancer by providing a constant growth signal to tumor cells. Consequently, cells producing EGFRvIII have an enhanced capacity for unregulated growth. Rindopepimut is designed to activate the patient’s immune response against tumor cells specifically expressing the EGFRvIII mutation.

About MDxHealth

MDxHealth is a leading molecular diagnostics company that develops and commercializes oncology-based molecular diagnostic testing for personalized medicine. The company’s tests are based on proprietary gene methylation technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit the MDxHealth website at www.mdxhealth.com.

This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the Company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation