Dutch molecular diagnostic developer Skyline Diagnostics will collaborate with Johnson & Johnson's Janssen Pharmaceuticals to develop a test to identify patients at increased risk of side effects from a Janssen drug.
Skyline CEO Henk Vietor told BioArray News last week that the research agreement is an extension of an earlier collaboration with Janssen to develop a method based on gene signatures to stratify patients based on their response to the same drug, a treatment for multiple myeloma.
"Obviously there is now a trend from the pharmaceutical industry to be more engaged in developing companion diagnostics, so… you see a lot of collaborations between diagnostic companies and pharmaceutical companies to add in genomic data," Vietor said.
In a statement announcing the collaboration, Skyline refers to the subject of the development partnership as an "undisclosed marketed compound."
Vietor said he could not name the drug, but disclosed that it is a Janssen product for the treatment of multiple myeloma. Janssen currently markets one drug for this indication: bortezomib, sold under the trade name Velcade.
Skyline is currently developing a prognostic assay for multiple myeloma, the MMprofiler, which is intended to classify patients into subtypes with prognostic significance. Vietor said that this test may or may not be combined with the companion diagnostic to be developed with Janssen.
The firm already markets a microarray-based assay to stratify acute myeloid leukemia patients, called AMLprofiler, which runs on Affymetrix’s GeneChip platform. According to Vietor, however, Skyline has not yet decided on a platform for MMprofiler or the Janssen companion test.
The company has been developing the MM efficacy test based on gene expression signatures, while the safety diagnostic work is currently investigating SNPs. Combining the two into a single assay would be ideal, Vietor said, but they might not end up being compatible.
The choice of testing platform "would very much depend on the outcome of the study," he said, as well as "costs, flexibility and partner." If the markers for the companion diagnostic turn out to be "simple and DNA-based," then PCR might be the best choice, he said. "If complex, an array might be considered."
Under the terms of the research agreement, Skyline will receive research and development funding, and could be paid additionally for the achievement of research milestones, the company said.
The collaboration with Janssen is Skyline's first partnership with a pharmaceutical company, but Vietor said several "smaller and larger companies" have now approached the diagnostics developer, interested in similar deals.
"I think within the next two weeks we will announce a second collaboration for the development of a companion diagnostic," he said.
Vietor said that companion diagnostic development has been a focus of Skyline's strategy from the company's start, though interest from pharma has only now started to grow. According to Vietor, some drug developers have been reluctant to engage in diagnostic partnerships because they feared it might diminish the market size for their drug products. Now, he said, things seem to opening up.
"What we've noticed … is that this resistance is breaking down, specifically over the last year," he said. "I know this is only starting, but you see — specifically at some companies — a real switch and a real eagerness to collaborate," he said.
That eagerness is paying off for other companies that have developed array-based tests. Agendia in May inked a companion diagnostics deal with AstraZeneca in the area of colorectal cancer (BAN 5/24/2011). Almac Diagnostics last year entered into a similar agreement with Merck KGaA, one of several for the firm. In that collaboration, Almac, Merck, and the UK's Medical Research Council will collaborate on a study of potential biomarkers of response to the cancer drug Erbitux (BAN 4/13/2010).
Skyline received a CE-IVD mark earlier this year for AMLprofiler, an Affy-based test that uses a gene-expression signature to classify patients into one of eight AML subtypes.
At the time, the company was beginning a series of clinical studies to generate data toward applying for clearance of the AML test from the US Food and Drug Administration (BAN 3/15/2011).
Vietor said last week that these trials are now "well on their way," both in Europe and the US. "We think we [will] have all the data collected at the end of this year," he said.
The launch of AMLprofiler has further established the company, Vietor said, and may be encouraging some of the recent interest Skyline has received from pharmaceutical companies.
"Now that we have a clearer position on the market with our first products being launched in March and our FDA studies now well on their way, [as well as] products in development for other indications in the hematological space, there's much more feasibility," Vietor said.
Skyline has two other tests in its pipeline, including the ALLprofiler, a prognostic assay for acute lymphatic leukemia in children, and the MMprofiler for multiple myeloma.
The Dutch government, which has funded much of the company's development work, recently awarded the company a €2 million ($2.9 million) grant to support the development of MMprofiler.
Skyline lists on its website the prediction of side effects and response to "one of the new major drugs in MM treatment" as two of the expected features of MMprofiler, but Vietor said it has yet to be determined whether the Janssen companion assays will be combined with MMprofiler in any way.
Vietor said Skyline anticipates MMprofiler will be on the market for research use at the end of this year and hopes to receive a CE-IVD mark for the test a year later.
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