A ‘crucial' partnership

BUFFALO, N.Y.—Empire Genomics has announced theacquisition of an exclusive license for patent-pending novel genomic biomarkersfrom Atlanta-based Emory University. The biomarkers will be used to develop amolecular diagnostic that ideally would be able to determine ideal therapeutictreatments for sufferers of multiple myeloma, and the team will be movingforward into a Phase II biomarker-driven clinical trial using this technologyto secure validation of its ability to predict patient outcomes in new generationsof drugs for multiple myeloma.

"This is a meaningful breakthrough in thearea of personalized medicine, and we are excited to work with Emory Universityand Dr. Bernal-Mizrachi to bring it to the market to help oncologists make moreinformed treatment decisions for this dreadful disease," Anthony Johnson,CEO of Empire Genomics, said in a press release.

Empire Genomics will make use of the test, andothers in development, to support and accelerate clinical trials and thedevelopment of companion diagnostics for cancer therapies. This test will seeuse in clinical trials and be launched through clinical labs early next year.The biomarkers are expected to have some potential in additional indicationssuch as lymphoma, and are undergoing investigation in some cancers.

"Developing a clinically validated multiplemyeloma cancer theranostic assay with informative data would represent a majorbreakthrough in improving disease management," Dr. Leon Bernal-Mizrachi,assistant professor of hematology and medical oncology at Emory UniversitySchool of Medicine, said in a statement. "It would fulfill an unmetmedical need to help patients with multiple myeloma better plan treatmentoptions that will help produce the best outcomes."

Diagnostic tests such as these, Johnson says, arecrucial.

"I think when you look at the cost of thesedrugs ... I think that having a biomarker that can actually identify whichtreatment is ideal for a given patient is going to improve healthcare, qualityof life, as well as the decision-making process for families and cliniciansacross the globe," he says.

As for whether he foresees diagnostic testsbecoming a key feature in more therapeutic areas, Johnson notes that, "youcan't really say which diseases will be amenable to personalized healthcare,but you're definitely going to imagine those out there right now would do wellby having a biomarker and more specific treatment."

Approximately 10 percent of blood-based cancersare multiple myeloma, and roughly 21,700 new cases—and 10,710 deaths—areexpected in the United States alone for 2012. In this particular cancer, plasmacells in the bone marrow grow uncontrollably and form tumors in the bone, whichmakes it difficult for the bone marrow to produce healthy blood cells. Thecancer is particularly prevalent in the aging population, and while therapeuticadvances have led to improved response rates, the treatments come withsignificant side effects.

There is definite need for such a biomarker forthis indication, Bernal-Mizrachi notes, as none yet exists for multiple myelomathat can guide physicians in treatment decisions.

"This biomarker will be the first of itskind, and will be the first that will allow a physician to decide whether ornot a patient should be exposed to a certain drug, and will also guide thephysician to say which will be the best combination that will be capable ofovercoming the resistance inherent by this genetic abnormality," heexplains.

Johnson calls academia-industry partnerships suchas this "crucial," noting that without the innovation and researchfocus of academic organizations such as Emory, the biomarker never would havebeen discovered.

"I think there needs to be a very close linkagebetween the academic research institutions out there, and translate those intocompanies like ourselves that are willing to work with them at a very earlystage, and then transition these actual technologies into clinically relevantand high-quality assays that are scalable and can be provided in aquality-controlled manner across the globe," he says. "And that'swhere we see that kind of nexus between the research institutions and theindustrial firms such as Empire Genomics."