Minding their assays

AUSTIN, Texas—With a combination of a schizophreniabiomarker portfolio and a biomarker identification platform, Rules-BasedMedicine Inc. (RBM) in early December announced an exclusive research andlicensing agreement with Roche through RBM's majority-owned subsidiary, PsynovaNeurotech Ltd. of Cambridge, United Kingdom.

Using Psynova's schizophrenia biomarker portfolioand RBM's DiscoveryMAP technology, the deal calls for collaboration on thediscovery, development, validation and commercialization of diagnosticimmunoassays to aid the clinical development and commercial differentiation ofnovel treatments for schizophrenia.

"We've been selling biomarker testing services topharma companies since 2002, but it's only in the past several years that we'vehad biomarker patterns that are specific to particular disease areas, and thesehave been important in our ability to start conversations with various pharmacompanies to use these panels for their biomarker research," notes Dr. SamLaBrie, vice president of corporate development at RBM. "We're very interestedin neuroscience in particular and we don't just want to be the company that yougo to just to run a few samples."

Instead, RBM wants to be a strong part of thediscovery and development process and the launching of companion diagnostics,he says.

"We have all these immunoassays that areauthenticated and sensitive and on the same platform where we could develop acompanion diagnostic, so it's a very efficient development pathway," LaBriesays. "We basically offer discovery, validation and commercialization all onsame platform, and we see ourselves as a great partner on companiondiagnostics."

Under the terms of the agreement, Roche willcontract Psynova to identify candidate serum protein biomarkers that seemuseful in the prognosis of disease progression and in predicting or monitoringthe efficacy and safety of an undisclosed compound from Roche's central nervoussystem pipeline.

Psynova will use its proprietary schizophreniabiomarker panels, its extensive central nervous system disease database and itsaccess to RBM's DiscoveryMAP technology to identify a specific biomarkersignature that could serve as a companion diagnostic. Any resulting companiondiagnostic will be developed either by Psynova and RBM—which serve as thepreferred developer for the companion diagnostic in partnership with Roche—orindependently by Roche, which would result in milestone and royalty payments toPsynova.

"We are excited to enter into this partnershipwith Roche," said Dr. Sabine Bahn, chief scientific officer and founder ofPsynova. "This alliance is part of an ongoing strategy to leverage the value ofour biomarker portfolio in both the development of novel diagnostic aids forphysicians and the accelerated development and delivery of novel therapeuticsfor patients."

According to data cited by Roche and RBM in theirannouncement of the deal, schizophrenia affects some 4 million people in theEuropean Union and 2.4 million people in the United States.

Moreover, each year as many as 2 million newpatients in the European Union and 1.3 million new patients in the UnitedStates present with early signs of psychosis. Although most of these patientsdo not have schizophrenia, the medical evaluation is time consuming andexpensive, due to its subjective nature. Biomarkers have the potential tofacilitate identification of patients that will benefit from specifictreatments and monitor their responses during treatment, thus making the entireprocess better for patients and healthcare providers alike.

Rules-Based Medicine is a CLIA-certified biomarkertesting laboratory that solves complex therapeutic development, diagnostic andtreatment challenges with innovative products and services. The company'sproprietary multi-analyte profiling (MAP) platform, from which the DiscoveryMAPtechnology derives, is said to make the drug discovery and development processmore efficient and effective by providing preclinical and clinical researcherswith reproducible, quantitative, multiplexed immunoassay data for hundreds ofproteins from small sample volumes.

Building on the MAP platform, RBM has developed arange of solutions that include: a self-contained whole-blood culture systemthat brings reproducibility and simplicity to ex vivo immune responsemeasurement; novel and companion diagnostic tests for complex diseases andtherapies; therapeutic-specific MAPs custom-designed for late-stage clinicaldevelopment; and new assays for the early detection of renal damage.

Psynova Neurotech was established in 2005 by Bahnand Dr. Chris Lowe, a professor at the University of Cambridge, to build on 12years of research by Bahn in identifying novel biomarkers for neuropsychiatricillnesses. Psynova Neurotech, together with the Bahn laboratory and Rules BasedMedicine, recently announced the discovery and characterization of acombination of protein biomarkers that demonstrate utility as an adjunctive aidin the differential diagnosis of schizophrenia.

As a result of this clinical milestone, RBM madean additional investment in Psynova, which is how the company became amajority-owned subsidiary of RBM. Psynova and RBM are developing severalproducts in related therapeutic areas and are also actively exploring thepotential of these biomarker panels as companion diagnostics and therapymonitoring tools.