Being PARP of the solution

MDxHealth tapped by Newcastle University, Cancer Research Technology and Pfizer to help develop companion diagnostic for PARP-based ovarian and breast cancer treatment

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LIEGE, Belgium—Molecular diagnostics company MDxHealth SA announced in early February an agreement with U.K.-based Newcastle University and Cancer Research Technology (CRT), as well as New York-based Pfizer Inc., to collaborate on the identification and development of a biomarker predicting response to a drug candidate for PARP inhibition, PF-01367338, on which Pfizer, CRT and Newcastle University are collaborating.

All involved are reporting that the work is vital because the identification of a successful predictive biomarker could 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," says Jan Groen, CEO of Belgium-based MDxHealth, which was known as OncoMethylome Sciences SA until October of last year and has a U.S. headquarters in Durham, N.C. "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."

Groen adds that his company offers a platform with proven success, which he believes made his company that much more attractive to the three entities working on PF-01367338, noting that this agreement and similar ones with other pharmaceutical companies and academic institutions "build on our strong capabilities in the exciting and rapidly emerging field of companion diagnostics."

No one involved in the deal is releasing anything about financial terms, but they have noted that MDxHealth will provide biomarker discovery services, assay development services and clinical trial testing, and also will retain rights to any methylation-based commercial companion diagnostic test that may result from this collaboration.

Newcastle University, through research groups led by Prof. Nicola Curtin and Dr. Richard Edmondson, will participate in biomarker discovery and validation activities. CRT will have rights to develop and commercialize new biomarkers in other fields. Pfizer will contribute experimental and intellectual input through its translational research team in addition to funding the collaboration.

Groen notes that many chemotherapeutic agents attack cancer cells by disrupting them at the genetic level, blocking both proliferation and their ability to metastasize. But because the attack is at the DNA level, cancer cells can take advantage of natural DNA repair mechanisms to counteract the effects of chemotherapy. Researchers are now exploring how to effectively disarm cancer cells by removing their DNA damage repair capabilities, he says, and 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. PF-01367338 works by inhibiting PARP1 and PARP2, enzymes involved in cellular DNA damage repair.

As part of the collaboration, MDxHealth will profile the methylation patterns of DNA damage repair genes, and Groen says that MDxHealth's ultimate goal is to produce a high-throughput, clinically validated platform that can rapidly test for epigenetic defects in key DNA damage repair genes to support the design and implementation of clinical trials that can lead to the development of optimized, targeted therapies.

This comes at a time when MDxHealth has settled comfortably and confidently into its repositioned role—which started in earnest with last year's name change—of defining a new, commercial direction for the company that is based on its DNA methylation platform.

"We made excellent progress in our collaborative efforts towards the development of companion diagnostics with major pharmaceutical companies and in developing our own proprietary prognostic and predictive tests," Groen says. "In addition, we successfully out-licensed some of our non-core assets to companies that are able to further develop these assets and drive them forward to commercialization stage. In combination with our improved financial performance, our more aggressive commercial strategy should allow MDxHealth to ramp up near and mid-term revenues."

In addition to working with Pfizer on this most recent deal for PARP inhibition, MDxHealth also entered into two other agreements recently with major pharmaceutical companies for the development of companion diagnostics: GlaxoSmithKline PLC for its immunotherapeutic oncology program and Merck Serono for brain cancer.

Also in support of the company's new corporate strategy, MDxHealth appointed a new scientific advisory board in late March. The board members will assist MDxHealth management in the development of current pipeline programs, as well as advise on new directions for the application of the company's technology platform.

"Each person joining our new scientific advisory board is a pioneer in cancer molecular diagnostics, including prostate cancer, an indication where MDxHealth is particularly strong," notes Groen. "Their long-standing experience and extensive networks will provide us with invaluable hands-on strategic support in the development of our existing programs and help us open up new avenues for the application of our DNA methylation platform."

The members of the new advisory board are Dr. Jonathan I. Epstein of Baltimore, Md.-based Johns Hopkins University School of Medicine; Dr. James G. Herman of the Oncology Center at Johns Hopkins Medical Institutions; Dr. Gerrit A. Meijer of the Free University Medical Center in Amsterdam, the Netherlands; and Dr. Eric M. Wallen of the University of North Carolina Medical Center at Chapel Hill.

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