MDxHealth Closes Agreement with Pfizer, Newcastle University and CRT to Identify a Predictive Biomarker

MDxHealth Closes Agreement with Pfizer, Newcastle University and CRT to Identify a Predictive Biomarker for PARP inhibitor therapies

MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized cancer treatment, today announced that it has signed an agreement with Newcastle University (UK), Cancer Research Technology Limited (CRT) and Pfizer Inc. to collaborate on the identification and development of a biomarker predicting response to Pfizer, CRT and Newcastle University's drug candidate for PARP inhibition, PF-01367338. The partners believe identification of a successful predictive biomarker could potentially lead to the development of a companion diagnostic to guide treatment decisions in ovarian and breast cancers.

"MDxHealth's methylation platform is potentially suited for the development of companion diagnostics in a wide range of cancer indications," said Dr. Jan Groen, Chief Executive Officer of MDxHealth. "Our advanced capabilities run from discovery to proof of principle, using deep sequencing at our new Ghent facility, to assay development and clinical trial testing at our ISO-certified Liege laboratories. We offer a platform that has been tried and tested and is highly attractive for our partners. This and similar agreements with other pharmaceutical companies and academic institutions build on our strong capabilities in the exciting and rapidly emerging field of companion diagnostics."

PF-01367338 [works by inhibiting PARP1 and PARP2b enzymes involved in cellular DNA damage repair (DDR). As part of the collaboration, MDxHealth will profile the methylation patterns of DDR genes to seek to identify those involved in predicting tumor development and response to PARP inhibition. MDxHealth's aim is to ultimately set up a high throughput platform that is clinically validated to rapidly test for epigenetic defects in key DDR genes to support the design and implementation of clinical trials to enable development of optimized, targeted therapies.

Financial terms of the agreement were not disclosed. MDxHealth will provide biomarker discovery services, assay development services, clinical trial testing, and will retain rights to any methylation-based commercial companion diagnostic test that may result from this collaboration. Newcastle University, through research groups led by Professor Nicola Curtin and Dr. Richard Edmondson, will participate in biomarker discovery and validation activities. CRT will have rights to develop and commercialise new biomarkers in other fields. Pfizer will contribute experimental and intellectual input through its translational research team in addition to funding the collaboration.

About PARP inhibition
Many chemotherapeutic agents attack cancer cells by disrupting them at the DNA level to block proliferation and their ability to metastasize. Cancer cells take advantage of these natural DNA repair mechanisms to counteract the effects of chemotherapy. Researchers are now exploring how to effectively disarm cancer cells by removing their DDR capabilities. BRCA1 and BRCA2 are implicated in homologous recombinational repair. Recent studies suggest that PARP inhibition can augment DNA damage in cancer cells with defective homologous recombination such as in prostate, breast and ovarian cancers with mutations in the BRCA1 and BRCA2 genes.

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. MDxHealth collaborates with leading cancer research center such as Johns Hopkins University, Duke University, Lovelace Respiratory Research Institute, Eastern Virginia Medical School, Cleveland Clinic, Memorial Sloan Kettering, and major European academic medical centers. The company has a number of commercial and collaborative partnerships with LabCorp, Merck & Co./Schering Plough, GlaxoSmithKline Biologicals, Roche, Merck Serono, Qiagen, and other industry leaders.