By Turna Ray
Agendia has entered into a partnership with the Netherlands Cancer Institute and AstraZeneca, marking its first foray into the companion diagnostics space.
In the collaboration, the diagnostics firm and its partners will focus on accelerating the development of targeted colorectal cancer drugs, though it is also possible that Agendia will develop commercial companion diagnostics for specific drugs in AstraZeneca's pipeline.
To AstraZeneca's drug development capabilities and the Netherlands Cancer Institute's ongoing research into the molecular underpinnings of various cancers, Agendia will add its molecular diagnostics knowhow and bioinformatics support, helping the drug developer identify subpopulations that will respond to compounds targeting colorectal cancer.
Agendia secured approval from the US Food and Drug Administration for its breast cancer recurrence molecular diagnostic MammaPrint in 2007. In addition to its work in breast cancer, Agendia has identified molecular subtypes in colorectal cancer patients that appear to have differential responses to certain treatments. René Bernards, professor of molecular carcinogenesis at NKI and cofounder of Agendia, said in a statement that the collaborators hope to home in on the drivers of the onocogenic process in colorectal cancer molecular subtypes.
Agendia is in the final development stages for ColoPrint, an array-based gene expression profiling test for predicting the risk of distant recurrence of stage II and III colon cancer patients. Agendia plans to submit the test to the FDA for approval. The fact that Agendia has experience taking at least one molecular diagnostic through the FDA is a positive for AstraZeneca. The FDA has said that it needs to approve tests used to identify best responders to a drug and, as such, big pharma values regulatory expertise in its companion diagnostics partners.
Additionally, Agendia offers DiscoverPrint, a tool that helps pharmaceutical and biotech firms assess molecular subtypes in cancer for conducting stratified drug trials.
It is currently unclear whether Agendia plans to use ColoPrint, DiscoverPrint, or another test in its collaboration with AstraZeneca. Agendia was unable to respond to questions ahead of press time.
AstraZeneca's pipeline, last updated on January 27, lists several Phase I and II compounds for solid tumor cancers. These include inhibitors of MEK, PARP, AKT, JAK2, the CHK1 kinase, the TOR kinase, the FGFR tyrosine kinase, and an anti-ANG-2 monoclonal antibody, among others.
For AstraZeneca, the Agendia deal further expands its strategy to apply genomics to personalized cancer drugs in its pipeline. Last year, the UK's National Health Service and other European regulators permitted AZ to provide its non-small cell lung cancer drug Iressa to patients who have been identified by a genetic test to harbor EGFR mutations (PGx Reporter 06/02/2010).
In a separate companion diagnostics deal, AstraZeneca is using Myriad Genetics' BRACAnalysis test in clinical trials for its ovarian cancer drug olaparib. The test is being used to identify study participants who harbor BRCA mutations and therefore would respond well to the PARP inhibitor (PGx Reporter 06/30/2010).
According to ClinicalTrials.gov, AstraZeneca is looking at the safety and efficacy of olaparib in pretreated patients with measureable colorectal cancer. Patients are stratified in the trial by their microsatellite instability.
AstraZeneca is coupling its investment in personalized medicine with comparative effectiveness research that will identify specific drugs and disease states where investing in PGx strategies may pay off for the company. In February, AstraZeneca announced it was working with WellPoint's research subsidiary HealthCore to conduct CER that would inform its pipeline. "The breadth of data that will be available through the collaboration will also support studies of subpopulations, some of which may be genetically defined," AstraZeneca spokesperson Katie Lubenow told PGx Reporter at the time (PGx Reporter 02/16/2011).
In line with its personalized medicine focus, AstraZeneca's collaboration with Agendia "has the potential to benefit not only the direct participants, but also the scientific community as a whole on the basis of providing a much greater understanding of the various disease types in the colorectal field," Agendia CEO Bernhard Sixt said in a statement. "A key feature of this collaboration is that personalized medicine diagnostics may be developed far earlier in the development of new drugs than has previously been possible. Our collaboration marks a continued shift in how we think about companion diagnostics and how they will be developed in the years to come."
In addition to its 70-gene signature MammaPrint breast cancer recurrence test, Agendia also markets TargetPrint, a gene expression test that assesses a woman's level of estrogen receptor, progesterone receptor, and HER2/neu overexpression; BluePrint, a genetic test that classifies breast cancer into basal-type, luminal-type, and ERBB2-type (HER2/neu positive) molecular subclasses; and TheraPrint, a panel of 56 genes that the company believes can be used in disease prognosis and predictive therapeutic response to a number of treatments.
In the breast cancer space, Agendia's main competitor is Genomic Health, which markets the Oncotype Dx breast cancer recurrence test. Until recently, Genomic Health was a single-product company. But the firm launched a version of the Oncotype DX test for colon cancer last year and is planning to commercialize a third test on the same platform in prostate cancer in 2013.
By entering into a companion diagnostic partnership in colorectal cancer, Agendia is also looking to diversify its capabilities and expand its test menu.
The Dutch firm is planning to file an initial public offering this year, proceeds from which would support the commercialization efforts for MammaPrint and TargetPrint. Agendia also plans to use the IPO funds to finish validating its BluePrint and TheraPrint tests.
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