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With a Little Help from CEO s FDA Friends, Enodar Readies SNiPlus for August Launch

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With booster fuel provided by a recent $100,000 grant from the National Human Genome Research Institute, Enodar Biologic will launch its new SNP-analysis software in August, according to a company official.

The company, a spinoff from the Fred Hutchinson Cancer Center, will need all the help it can get to push beyond a platoon of competitors priming the market with similar platforms. But a handful of partnerships under its belt and an important, if uncommon, relationship with the US Food and Drug Administration in place may be enough to nudge the young company in the direction of market success.

Enodar also intends the new software, called SNiPlus, to occupy a novel corner of the drug-discovery and -development framework: Rather than market the platform as a way to analyze SNP data in early-stage clinical or even preclinical trials, Enodar intends to sell the software as a tool to help drug makers revive failed compounds and study newly approved drugs in Phase IV trials.

Enodar has already developed software that in principle enables researchers to “deal with large sets of data,” and gives them the ability to identify markers and develop prediction markers, said Rob Arnold, Enodar’s COO. The SNiPlus platform is an extension of this software, which itself was licensed from the Hutch.

Enodar, which markets itself as a genomics contract research organization, hopes to roll out SNiPlus in August initially as part of its services offering. As a GCRO, Enodar mines gene-expression, genotyping, and other biological data, defines markers, and builds predictive models for its customers. Its customers so far have been academic and other research centers, including the Hutch and the Institute for Systems Biology a few blocks away.

Most recently, in April, Enodar partnered with the University of Washington to build a web-based database for translational state-array analysis. Under that deal, researchers at UW’s department of biochemistry will use the tool, called the Translational State Array Analysis database, which will use gene- and protein-expression technologies to study how translation influences cell-cycle regulation. The database will be finished in March 2004, and will be available to other researchers and the general public through a web browser.

Eventually, however, Enodar hopes to develop a platform that it can sell outright to drug makers for diagnostic and therapeutic applications, Arnold told SNPtech Reporter. “It’s really predicated on customer demand,” he said. “As the demand for this technology increases, we will make this technology more widely available. There’s also the recognition that there’s a lot of different technologies that are being considered.”

Arnold said that the SNiPlus platform “would be suitable for FDA submission.” There’s a good reason for his confidence: Lue Ping Zhao, the company’s CEO, has since last year been a “special consultant” to the FDA’s Center for Drug Evaluation and Research on the use of microarrays and SNP analysis.

Playing the Angles

Zhao, who oversees a research group at the Hutch that studies quantitative epidemiological genetics, founded Enodar in 2001 as a spin-off from the center. The company employs 25 staffers near the Hutch in Seattle, including biologists, IT specialists, biostatisticians, salespeople, and marketers. The firm also employs a small software-development team in Shanghai, China.

Soon after creating the company, Zhao noticed that the SNP-analysis market was very competitive, and that most drug makers “tend to be very conservative.” However, he eventually found a potentially lucrative — if little used — R&D niche.

“The one angle that I had been talking about and that companies have been very receptive and listening to me [about] is to rescue potential drugs, or even looking at Phase IV” data, Zhao told SNPtech Reporter two days after his company won the $100,000 NIH grant.

He described an AstraZeneca non-small-cell lung cancer drug Iressa recently approved by the FDA. This drug was approved with “a lot of constraint” because it was shown to work in only 15 percent of patients, in whom the drug was very effective.

The FDA, faced with these stark data, typically wants drug companies to discern why such a narrow patient population experienced positive results while a majority of patients floundered. Zhao said SNiPlus can be used to help locate mutations linked to drug response. This application of SNP analysis also happens to be a central tenet of pharmacogenomics and a major focal point in the FDA’s drive to greenlight genotype and gene-expression data.

In fact, Zhao has something of a ringside seat to the FDA’s pharmacogenomics machinations: Last summer, Zhao began collaborating with CDER to investigate the utility of the SNiPlus platform in the study of toxicity.

Since that time, Zhao has also advised the agency on how drug makers can use — and how the FDA might regulate — SNP-analysis software as a component of pharmacogenomics.

Zhao said a prototype of the SNiPlus platform has already been built, and Enodar is “ready for a collaboration.” The software can be used right now, he said. In August, Enodar will ask the NIH for $700,000 in additional grants to develop.SNiPlus for sale. An answer is expected around Christmas.

— KL

 

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