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MDx/CDx Focus: Abbott, Merck's Companion Dx Deal; Foundation Medicine Nets another Pharma Partner

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Abbott, Merck Ink Companion Dx Deal to Personalize Unnamed Cancer Treatment

Abbott and Merck are evaluating the use of a fluorescence in situ hybridization-based companion diagnostic test to determine which patients are likely to respond to an unnamed investigational cancer therapy in Merck's pipeline.

Under the terms of the deal, Abbott will develop a FISH-based diagnostic to gauge deletions in the tumor protein 53 gene. The TP53 gene encodes the tumor suppressor protein 53, which is often referred to "as the guardian of the genome" due to its ability to prevent cancer-causing gene alterations.

Although the partners did not name the investigational agent that Abbott's FISH tests will help personalize, data from published studies and ClinicalTrials.gov suggest that Merck's MK-1775 may be the molecule of interest in this collaboration.

In 2011, researchers from Johns Hopkins University, Merck Research Laboratories, and elsewhere published a study in Clinical Cancer Research investigating efficacy and pharmacodynamic effects of Merck's MK-1775 as a single agent and in combination with gemcitabine using a panel of p53-deficient and p53 wild-type human pancreatic cancer xenografts. The results from that study indicated that MK-1775, an inhibitor of the Wee1kinase, "selectively synergizes with gemcitabine to achieve tumor regressions, selectively in p53-deficient pancreatic cancer xenografts."

Merck is currently studying the drug in a variety of solid tumors. The company is recruiting patients with P53-mutant ovarian cancer to study the safety and efficacy of MK-1775 in combination with paclitaxel and carboplatin. In the first part of the trial, Merck researchers will give a small group of participants the MK-1775/paclitaxel/carboplatin regimen in order to identify the maximum tolerated dose. In the second part of the study, Merck will randomize patients to receive the MK-1775 regimen or just paclitaxel plus carboplatin.

The drug developer is also recruiting p53 mutated epithelial ovarian cancer patients who have relapsed early after first-line treatment with paclitaxel/carboplatin combination therapy, to see if they will benefit from treatment with MK-1775 and carboplatin.

Outside of its collaboration with Merck, Abbott has companion diagnostic development agreements with a number of drug developers, including Pfizer and GlaxoSmithKline. Last summer, Abbott's Vysis ALK Break Apart FISH Probe kit was approved by the US Food and Drug Administration as a companion diagnostic for Pfizer's non-small cell lung cancer drug Xalkori.


Foundation Helping Array Study Treatment Response in Molecularly Defined Subpopulations

Foundation Medicine, a company developing a next-generation sequencing based comprehensive cancer test, said this week that it has inked a collaboration with Array BioPharma, adding to similar deals the firm has with Sanofi, Johnson & Johnson, Novartis, and Celgene.

According to the company, Foundation Medicine will use its genomic sequencing platform and analytic knowhow to assess molecular alterations that may help Array develop treatments for specific subpopulations of cancer patients.

According to Array's website, it is investigating several molecularly targeted drugs in early development programs. The company is developing ARRY-380, a reversible and selective HER2 inhibitor, which may be particularly effective in the approximately one-third of HER2-positive patients who express high levels of a truncated form of HER2 receptors.

Array is also developing ARRY-520, an inhibitor of the kinesin spindle protein in multiple myeloma; and ARRY-614, an inhibitor of p38 and Tie-2, in myelodysplastic syndrome.

Through its collaboration with Foundation, Array aims to "understand how to identify patients who may respond to a given targeted therapy to ensure that each patient gets the optimal drug to treat their individual disease," Array said.

Foundation Medicine’s comprehensive cancer genomic test uses next-generation sequencing to analyze formalin fixed, paraffin embedded tumor tissue for alterations in approximately 200 cancer-related genes.

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