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Merck Enlists Life Tech to Develop Companion Test for Cancer Drug, Other Pipeline Opportunities

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Merck Serono has engaged Life Technologies to help it advance molecular diagnostics that can pick out best responders to its treatments.

The collaboration is initially centered on an unnamed oncology drug, according to the partners. However, the deal holds opportunities for Life Tech to help Merck advance multiple drugs in a variety of therapeutic areas with a personalized, biomarker-driven strategy.

Under the terms of the deal, Merck's translational research team will identify biomarkers linked to treatment response using Life Tech's proprietary platforms. After identifying the opportunities for personalized drug development, the partners will jointly advance companion tests for the treatments. The partners will also work together on garnering regulatory approval for their drug/test combination products.

The technologies that Life Tech will use to advance companion tests include next-generation sequencing, Sanger sequencing, qPCR, and flow cytometry. "If successful, the agreement will be followed by a commercialization agreement under which Life Technologies will commercialize the companion diagnostic in agreed upon territories," the company said in a statement.

Life Tech and Merck did not release the financial terms of the collaboration.

Life Tech is a fairly new entrant to the clinical diagnostics space. The company gained access to its own CLIA-certified lab last year with the purchase of Navigenics, which gave Life Tech the resources to validate and commercialize its own diagnostics. The company also acquired its first molecular diagnostic through Pinpoint Genomics, now a Life Tech subsidiary. Pinpoint has developed a 14-gene expression panel that gauges which non-small cell lung cancer patients are at high risk for experiencing disease progression within a five-year window after surgery (PGx Reporter 7/18/2012). Life Tech has since commercially launched this test, called Pervenio.

"As Merck Serono is an industry leader, the current collaboration further establishes Life Technologies’ credibility as a partner to pharma for development and commercialization of companion diagnostics," Ronnie Andrews, president of genetic and medical sciences, told PGx Reporter.

While the deal with Merck is certainly a milestone for Life Tech in terms of growing its footprint in the companion diagnostics space, the company has worked with pharma before. For example, Life Tech partnered with GlaxoSmithKline in 2011 to develop a companion test for the drug developer's investigational MAGE-A3 cancer immunotherapy.

Meanwhile, Merck has been slowly entering the personalized medicine space in recent years and exploring opportunities to advance drugs with a molecularly targeted strategy. But the company has experienced a few disappointments and encountered the risks of developing molecularly targeted medicines.

Erbitux, developed by Lilly subsidiary ImClone, is marketed by Merck outside of the US and in Canada. Several years ago, the drug sponsors submitted data to regulatory authorities to indicate Erbitux for colorectal cancer patients who don't harbor certain KRAS mutations. The FDA last year approved Erbitux as a first-line treatment for metastatic colorectal cancer patients with EGFR-expressing, KRAS wild-type tumors and also approved Qiagen's KRAS RGQ PCR Kit alongside the drug (PGx Reporter 7/11/2012). The drug has a similar indication for colorectal cancer patients from the European Medicines Agency.

However, last year, Merck and Lilly said they were withdrawing the marketing applications in Europe and in the US to garner approval for Erbitux as a first-line treatment for NSCLC patients with high EGFR expression. In the US, Lilly pulled its application for Erbitux after the FDA asked for additional data showing Erbitux improved overall survival in NSCLC patients and data on a validated companion diagnostic that can pick out best responders to the drug (PGx Reporter 5/2/2012). Subsequently, a similar situation occurred with European regulators.

Merck also recently had bad luck with a large biomarker-driven late-stage trial for the investigational glioblastoma drug cilengitide. Researchers from Merck and elsewhere tested close to 3,500 patients for methylated MGMT under a collaboration with diagnostics firm MDxHealth (PGx Reporter 6/5/2013).

The MGMT gene is involved in cellular DNA repair, and past studies suggest that patients with methylated MGMT don't express the gene normally, which in turn makes tumor cells more sensitive to standard chemoradiation. After determining through MDxHealth's lab the methylation MGMT status of patients, researchers randomized 545 patients to receive either cilengitide in combination with temozolomide and radiotherapy or just temozolomide and radiotherapy.

In the study, presented at the American Society of Clinical Oncology's annual meeting earlier this year, median overall survival in both arms was 26.3 months, and median progression-free survival in the cilengitide arm was 13.5 months versus 10.7 months in the control arm. Upon analyzing additional subgroups in the study, researchers still could not find a single subset of patients with response that suggested activity with this agent. Despite the failure of this trial, Merck is continuing to study cilengitide in newly diagnosed glioblastoma with unmethylated MGMT and in non-small cell lung cancer.

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