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Qiagen, Lilly Partner to Develop JAK2 Companion Test for Investigational Blood Cancer Drug

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By Turna Ray

Qiagen and Eli Lilly have partnered to develop and commercialize a molecular diagnostic that will help pick out best responders to a blood cancer drug that is in early development in Lilly's pipeline.

The blood cancer drug, which targets the Janus kinase 2 gene, is currently in Phase I development, according to Lilly's pipeline posted online. The JAK2 gene has been previously associated with myeloproliferative neoplasms, a type of blood cancer that induces aberrant growth in blood cells. It is estimated that approximately 50 percent of patients with myelofibrosis carry the JAK2 V617F mutation.

Under the terms of the deal, Qiagen and Lilly will partner to take the JAK2 diagnostic through clinical trials and work together to manufacture and launch the test alongside the drug. Qiagen did not disclose the financial terms of its collaboration with Lilly.

Qiagen gained exclusive rights to the JAK2 biomarker through an agreement with Ipsogen, a French company that Qiagen is in the process of acquiring. "Getting access to the exclusive rights to JAK2 was certainly a key aspect for the acquisition of Ipsogen in the first place," a Qiagen spokesperson told PGx Reporter.

The spokesperson noted that Ipsogen has developed two JAK2 assays, the MutaSearch qualitative assay and the MutaQuant quantitative assay. The MyeloProliferative Disorders Research Consortium is currently using the MutaQuant assay in two international trials. The companion test being developed for Lilly's compound will differ from Ipsogen's existing diagnostics in that it will both quantitatively and qualitatively assess the JAK2 V617F mutation.

Qiagen's JAK2 diagnostic will be specifically optimized for sample types treated with the Lilly drug and for use on the company's Rotor-Gene Q PCR platform. While there are laboratories that currently offer JAK2 V617F analysis as a lab-developed test, Qiagen's JAK2 companion test will have to be reviewed and cleared by the US Food and Drug Administration. The company "also intends to seek regulatory approval for full automation of the workflow on the QIAsymphony RGQ," according to a Qiagen statement.

The deal between Lilly and Qiagen is not an exclusive arrangement, and as such, Qiagen is free to collaborate with other drug developers who are developing treatments that target JAK2.

"The JAK2 pathway is considered to bring high value to drug development in terms of defining and directing the right therapies for patients, and therefore represents a very important target of R&D initiatives in the pharmaceutical industry," Qiagen said in a statement.

A number of JAK inhibitors are being developed by various drug firms. For example, Sanofi-Aventis, through its acquisition of TargeGen last year, gained TG101348, a JAK2 inhibitor that is being developed as a primary and secondary treatment for myelofibrosis and polycythemia vera. Additionally, last year, researchers from MD Anderson Cancer Center, the Mayo Clinic, and Incyte published data in the New England Journal of Medicine from a Phase I/II study investigating Incyte/Novartis' JAK2 inhibitor INCB018424.

In this study, researchers led by MD Anderson's Srdan Verstovsek found that INCB018424 caused dose-dependent suppression of STAT3, a marker of JAK signaling, in patients with wild-type JAK2 and in those with the JAK2 V617F mutation. When patients were giving a 15 mg starting dose of the drug and then had their doses individually titrated thereafter, 17 out of 33 study participants, or 52 percent, experienced an objective response that lasted for a year or more. The therapy caused grade 3/4 adverse events, most commonly myelosuppression, in less than 10 percent of patients.

Separately, Pfizer's tofacitinib, which inhibits the JAK3 enzyme, is being developed as a treatment for rheumatoid arthritis. In April, Pfizer announced results from two Phase III studies showing that tofacitinib reduced patients' rheumatoid arthritis symptoms compared to placebo. The drug developer has not announced that it is using a companion test in the development program for tofacitinib.


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