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Clavis Pharma Taps Skyline Dx for Array-based Patient Selection in AML Drug Trial

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By Justin Petrone

Snagging its second companion diagnostics deal in as many months, Skyline Diagnostics this week announced a research agreement with Clavis Pharma to assist the Norwegian pharmaceutical company in the development of a drug for acute myeloid leukemia.

Skyline CEO Henk Vietor told BioArray News that Skyline will use Affymetrix-manufactured arrays to identify gene-expression biomarkers for the selection of individual AML patients that may benefit from Clavis' compound.

The drug, elacytarabine, is an elaidic acid derivative of cytarabine and is currently undergoing a phase III study for treatment of patients with relapsed or refractory AML. Oslo-based Clavis expects to enroll approximately 400 patients in the study, and estimates that top-line data will become available in the fourth quarter of 2012.

Vietor said that the firm will use its array-based AMLprofiler test as well as Affy's U133 Plus 2.0 GeneChip to find a correlation between specific genes, including hENT1, and clinical response to cytarabine. The company previously identified a correlation between hENT1 status and response to first-line cytarabine therapy. Skyline achieved a CE-IVD Mark for AMLprofiler, a GeneChip-based assay that can be used to stratify acute myeloid leukemia patients, earlier this year (BAN 3/15/2011).

The deal with Clavis is the second partnership with a pharma company for Rotterdam, the Netherlands-based Skyline in recent months. The firm in July announced a collaboration with Johnson & Johnson's Janssen Pharmaceuticals to develop a test to identify patients at increased risk of side effects from a Janssen drug for multiple myeloma (BAN 7/26/2011).

Athos Gianella-Borradori, chief medical officer at Clavis Pharma, in a statement called the firm's cooperation with Skyline an "important collaboration" and said Skyline's "expertise will be instrumental in searching for gene-expression patterns" that can be used in the biomarker program for elacytarabine. He added that the deal expands the program to include gene- expression profiles, as patient selection to date has been based on protein markers. Genomic information will "deepen" Clavis Pharma's "insights into the potential for precise and highly effective personalized medicines," he said.

This is the first partnership for Clavis Pharma and Skyline. Vietor said that the possibility exists for the two firms to expand their activities in the future.

"This collaboration is on hENT1 and related genes in the biomarker program of elacytarabine, so it fits with Skyline Diagnostics' hematology expertise," he said. "However, any drug program can benefit by using our bioinformatics expertise and profilers," he said. "When there is a known biomarker or a pathway that is associated with a drug, Skyline Diagnostics can specifically analyze the expression of the gene or set of genes in relation to a patient’s drug response, so, yes, there is a potential to broaden our collaboration."

Vietor said that the firm, which anticipates US Food and Drug Administration clearance for its AMLprofiler test next year, is also keen to "strengthen its companion diagnostics activities." In particular, Skyline expects more deals to materialize once a second test in development for multiple myeloma patient stratification, called MMprofiler, becomes available later this year.

Like AMLprofiler, MMprofiler is also manufactured by Affy.

Vietor noted that there are a number of compounds in clinical trials for multiple myeloma "and profiling could add a substantial value in these trials in terms of optimizing diagnostics … and reducing the duration of trials," said Vietor. He added that pharma companies could see in MMprofiler the "potential to define responders within such a trial, which can lead to the development of a companion diagnostic test to be used in combination with the drug." He did not elaborate.

When asked if Skyline's companion diagnostics activities have benefited from the recent CE-IVD marking of AMLprofiler, Vietor said that the firm's own test business and its drug- development partnerships are not explicitly linked. Still, he said that Skyline's "ability to translate genetic signatures into regulatory approved and clinically applicable products … is being recognized by pharma."

Deals like those with Clavis Pharma and Janssen Pharmaceuticals are likely to lead to additional partnerships, he noted. "Of course, having more collaborations with pharma on companion diagnostics lowers the hurdle for another pharma company to start a collaboration with us," he said.

Other companies developing array-based tests, including a number of Affy partners, are also benefitting from companion diagnostics deals. Last year, Merck partnered with Roche to use its Affy-manufactured AmpliChip p53 in selected clinical trials (BAN 2/23/2010).

More recently, in May, Amsterdam-based Agendia inked a companion diagnostic deal with AstraZeneca in the area of colorectal cancer (BAN 5/24/2011). Agendia's arrays are manufactured by Agilent Technologies.

Vietor said that it is likely that firms developing array-based tests will look to companion diagnostic deals as a revenue opportunity in the future.
Developing array-based tests "is not so easy," said Vietor. "In most cases, a strong pharmaceutical company to share risk-return will be favored," he said, noting that reimbursement and acceptance of the test "will be much higher" in such a configuration.

He added that the nature of such companion diagnostics deals in the future will be shaped by the companies involved. For example, a smaller pharma with limited financial resources will "probably favor a deal where the diagnostic company will develop and market" the resulting test, while for a "large pharmaceutical company with a lot of money and interest in diagnostics, a pure contract research program will be favored."

The "same is true for the diagnostic company and also depends on the stage, business model, and cash position," said Vietor. "On the one hand of the spectrum, a small diagnostic company with little cash will welcome a lucrative contract research deal," he said. On the other hand, a well-funded diagnostics firm will favor a co-development deal, Vietor said.

Vietor characterized Skyline as the former, stating that his firm and Clavis Pharma are "young, innovative companies."


Have topics you'd like to see covered in BioArray News? Contact the editor at jpetrone [at] genomeweb [.] com.

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