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Epistem Signs $4M Biomarker Deal with Sanofi-Aventis; Preps PoC Platform for Companion Diagnostics

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By Bernadette Toner

Epistem last week announced that it has signed a three-year collaboration with Sanofi-Aventis to use its proprietary biomarker discovery technology as part of the pharmaceutical firm's oncology programs.

The agreement, worth up to $4 million, will cover preclinical, ex vivo, and clinical studies and is aimed at providing Sanofi-Aventis with gene expression biomarkers that will identify patient response to drugs.

The companies did not provide further details about the scope of the collaboration, but Epistem CEO Matthew Walls told Pharmacogenomics Reporter that it is in line with the company's goal to move into the companion diagnostics space.

Epistem is currently beta-testing a point-of care molecular diagnostic platform called Genedrive that Walls said will be able to deliver test results in under 30 minutes at a "fraction" of the cost of currently available testing platforms.

The platform, which has been under development for the last five years, is about the size of an iPad and works with cartridges loaded with assays for various diagnostic applications. Wall said that Epistem plans to launch the platform some time in the next few months.

The Manchester, UK-based company believes that Genedrive will eventually find use in a range of point-of-need applications — from infectious disease to agricultural and veterinary work — but Walls noted that in the short term, the company sees the platform as a natural progression for its existing biomarker discovery business.

"We can translate from the discovery of the biomarker in relation to the drug through to the point at which we can then use Genedrive for a downstream diagnostic with the drug," he said. "Once we're confident of the marker and its effect, we can then move that onto Genedrive as a companion diagnostic."

In addition to Sanofi, Epistem counts Novartis, AstraZeneca, and Johnson & Johnson among its biomarker collaborators.

Wall said it's likely that Sanofi and the company's other pharma partners would want to work with the company to move biomarkers onto the Genedrive testing platform.

"Genedrive will be used by Sanofi in the future," he said. "I think that's for the next phase of development."

Founded in 2000, Epistem's initial focus was on epithelial tissue, tumors, and stem cell control. In 2009, it expanded its efforts into biomarker discovery, and then last year expanded that effort again to form a Personalized Medicine business unit, which joined its more established Contract Research Services and Novel Therapies businesses.

For the company's most recent fiscal year, which ended March 31, 2010, the Personalized Medicine business contributed £800,000 ($1.3 million), or 14 percent of the company's total revenues of £5.7 million. Sales for the biomarker business grew 19 percent year-over-year.

The biomarker business is based on Epistem's proprietary gene expression platform, called GenetRx, and its RNA-Amp technology, which allows researchers to amplify cDNA from samples as small as 10 picograms. Epistem has also compiled a database, called PathwayDirect, which includes gene expression information on healthy normal volunteer samples and data from clinical and preclinical studies.

Epistem's biomarker discovery business relies heavily on the company's background in epithelial tissue — particularly in the area of oncology since the company estimates that epithelial cancers account for more than 80 percent of adult cancers.

In particular, the company has combined its expertise in epithelial tissue and its amplification technology to develop a minimally invasive system in which it amplifies RNA from the base of a single, plucked human hair in order to perform gene expression measurements without a biopsy.

The company first measures gene expression in the hair of a subject prior to treatment. "We then administer a drug and take a different hair at a different time point afterwards," Walls said. "The hair is a surrogate sample of epithelial tissue, so you're not required to go invasively to take a biopsy. It's a very simple and effective way of seeing a drug's effect in epithelial tissue, so it lends itself to use in oncology."

Walls said that the company primarily uses the technology to assess pharmacodynamic response. "We're taking surrogate tissue and from that we are able to see the effects of the drug in relation to the oncology pathways that we're looking at, so systemically we can get a read as to what the drug is doing," he said.

In 2008, at a meeting sponsored by the American Association for Cancer Research, the National Cancer Institute, and the European Organization for Research and Treatment of Cancer, Epistem presented a preliminary study, conducted with AstraZeneca, that showed its plucked-hair method was well tolerated by patients and also provided reliable results.

At the AACR-NCI-EORTC conference the following year, the company presented data on two clinical studies. One, conducted with 12 healthy normal volunteer elderly men, identified a panel of seven genes that were reliably expressed in most scalp hairs and could be used to monitor drug-induced gene expression changes for compounds targeting the androgen receptor pathway. In the second study, the company used hair follicle analysis to identify pharmacodynamic markers to support dose scheduling decisions for Enzon Pharmaceutical's investigational compound EZN-3042, a survivin mRNA antagonist.

The company said that it has also used its GenetRx technology to monitor the effects of Genentech/OSI's EGFR inhibitor Tarceva and Lilly's cMet inhibitor Gemzar.


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

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