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MDx/CDx Focus: Qiagen; Dako & Amgen; Ventana & Pfizer; Foundation Medicine & Sanofi; and More


Qiagen Expands Companion Diagnostic Portfolio

Qiagen has received approval of its Therascreen EGFR Mutation Detection Kit RGQ from Japanese regulatory authorities.

The company said that the test can be used to personalize treatment for various cancer drug targeting EGFR. Qiagen characterized Japan has "one of the world’s largest markets for companion diagnostic tests."

The EGFR test marks Qiagen's second approval in Japan. In April 2011, Japanese health regulators approved Qiagen's Therascreen KRAS Mutation Detection Kit.

Qiagen estimates the market in Japan for EGFR and KRAS testing to be approximately 100,000 patients per year.

“Japanese and other East Asian populations generally have a higher rate of EGFR mutations than other groups, and non-smoking East Asian women are the largest potential market for EGFR-inhibitor anticancer drugs," Stephen Little, Qiagen's VP of global personalized healthcare, said in a statement.

Qiagen also has plans to market the EGFR and the KRAS tests in the US as companion diagnostics.

Qiagen has a deal with Boehringer Ingelheim to develop an EGFR mutation-detecting companion test for the non-small cell lung cancer drug BIBW 2992. Also called afatinib, the drug is an irreversible EGFR/HER2 inhibitor (PGx Reporter 6/1/2011). Qiagen has also submitted its KRAS test with US regulatory authorities for approval as a companion diagnostic to two colorectal cancer drugs, Vectibix and Erbitux.

Qiagen separately announced this week that it has entered into a worldwide co-development and licensing deal with Insight Genetics that will give it access to IP for the ALK marker, which is implicated in lung cancer. Qiagen intends to collaborate with Insight to develop a companion diagnostic that gauges ALK mutations, and can help personalize lung cancer treatments.

Additionally, Qiagen subsidiary Ipsogen formed a deal with Personal Genetics that will give Qiagen the worldwide exclusive rights to diagnostics for mutations in the IDH1 and IDH2 genes associated with brain cancers, acute myelogenous leukemia, and certain other malignancies.

Dako and Amgen to Develop CDx for Drug Treating Rare Cancer

Dako this week said it is working with Amgen to develop a companion test for an investigational treatment for "a rare and deadly cancer."

The partners did not name the drug candidate that they plan to develop with a companion test. However, the fact that it is a treatment for a rare cancer suggests that if the product successfully completes clinical trials, it will likely receive orphan drug status from the US Food and Drug Administration.

Under a 1983 law, an orphan drug is defined as a treatment for a disease that affects fewer than 200,000 patients in the US. Pfizer's drug Xalkori, targeted for non-small cell lung cancer patients with ALK mutations, was approved in August 2011 by the FDA as an orphan drug. Xalkori is indicated for NSCLC patients only if they have ALK rearrangements in their tumors after being tested with Abbott Molecular's Vysis ALK Break Apart Fluorescence In Situ Hybridization Probe Kit (PGx Reporter 9/7/2011).

Outside of its collaboration with Amgen, Dako is a leading player in the companion diagnostics market, with deals in place with AstraZeneca, Bristol-Myers Squibb, and Genentech.

Ventana to Develop New IHC-Based AKL CDx for Pfizer's Xalkori

Under a collaboration with Pfizer and a license agreement with Cell Signaling Technology, Roche subsidiary Ventana Medical Systems will develop a fully automated immunohistochemistry companion diagnostic that gauges ALK rearrangements.

Pfizer in August received approval for its NSCLC drug, Xalkori, indicated for patients whose tumors harbor ALK rearrangements. At the time of the drug's launch, Abbott Molecular's Vysis ALK Break Apart Fluorescence In Situ Hybridization Probe Kit was simultaneously approved as the companion test for Xalkori (PGx Reporter 9/7/2011).

Ventana's IHC-based ALK test, if it passes muster through the necessary regulatory bodies, could offer another testing option for patients receiving Xalkori. Additionally, the test may be used in the development program for other drugs in Pfizer's pipeline.

An IHC-based test will need to show concordance with or be an improvement on the FISH-based test in order to be approved as a companion test that picks out best responders to Xalkori. Different platform technologies measure the ALK marker in different ways. While FISH tests detect ALK rearrangements, IHC tests gauge the expression of the ALK protein, and PCR-based tests can hone in the specific ALK fusion partner.

In 2010, Yung-Jue Bang, a professor at the Seoul National University College of Medicine and a Pfizer collaborator on Xalkori's development program, said that the Abbott FISH test had nearly 100 percent concordance with IHC tests conducted in his laboratory (PGx Reporter 6/9/2010). Pfizer has said it is also exploring RT-PCR platforms for ALK testing.

Under the terms of the collaboration with Pfizer and CST, Ventana will develop an ALK rearrangement test based on CST's D5F3 antibody and Ventana's OptiView DAB detection that will run on Ventana's automated platforms. CST and one of its partners own "dominant rights" to the IP for the detection of EML4-ALK translocations.

"Our early development data suggests that the combination of CST's D5F3 antibody and Ventana OptiView detection generates a highly sensitive assay that detects cases with very low expression of the ALK protein in lung tissue, which means that Xalkori may be an appropriate treatment for those patients," Ventana's President Mara Aspinall said in a statement.

Ventana claims that with an IHC-based test, users will have efficient laboratory workflow through automation, faster analysis, and will save money over other test platforms.

Morphotek, Fox Chase Collaborate to Obtain Patient Samples for the Development of CDx for Oncologics

Eisai subsidiary Morphotek has inked two deals with Fox Chase Cancer Center through which it will acquire clinical samples that it will use to develop and validate companion diagnostics.

"These assays are intended for use in the identification of patients who will be suitable for treatment with targeted antibody therapeutics currently being developed by Morphotek," the company said in a statement.

Morphotek will fund prospective and archival sample collection programs to obtain samples from patients who are diagnosed and being treated for various cancers at Fox Chase. The company will then use these samples to develop companion diagnostic assays that will identify best responders to its investigational therapeutic antibodies or will monitor patient response to targeted therapies.

Samples received from Fox Chase are being used to advance companion tests for Folate Receptor Alpha, the target of Morphotek's lead therapeutic candidate, farletuzumab. The drug is in clinical trials for several different types of cancer, including non-small cell lung cancer and ovarian cancer.

"Studies have found expression levels to be variable between different cancer types," Morphotek said in statement. "In light of this variability, a diagnostic assay that can identify patients with FRA-positive cancers may enable better diagnosis and treatment of patients affected with FRA-expressing cancers."

Foundation Medicine Inks Fifth Pharma Collaboration with Sanofi

Under a newly formed collaboration with Sanofi Aventis, Foundation Medicine will use its genome sequencing and analysis knowhow to discover markers that can be developed into companion tests for Sanofi's drug candidates.

According to Foundation Medicine, this latest collaboration marks its fifth deal with a pharma partner. Previously, Foundation inked similar agreements with Johnson & Johnson Pharmaceutical Research and Development, Novartis, Celgene, and an disclosed drug firm. Under these collaborations, Foundation uses its next-generation sequencing based platform to analyze formalin-fixed, paraffin-embedded tumor samples and gauge disease-associated mutations in more than 200 genes implicated in cancer.

Foundation Medicine, launched in 2010, is a personalized medicine-focused company that aims to apply next-generation sequencing to individualize cancer treatment (PGx Reporter 4/21/10). The company is in the business of developing "comprehensive" cancer molecular diagnostics, but has stated it is platform-agnostic when it comes to using a specific type of sequencing technology.

Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at tray [at] genomeweb [.] com.

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