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Ardais Pursues New Business Model; Duke Cancer Alliance Is Inaugural Deal

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Ardais is taking itself one step closer to becoming a pharmacogenomics player — and in the process is changing the way it does business.

This week, the closely held tissue-banking company said it has begun helping researchers at Duke University Medical Center collect and store tissue samples from women with breast cancer.

The deal, which uses Ardais’ newly launched Biospecimen Management System, or BMS, will also equip Duke scientists and oncologists with a repository of molecular data collected from these samples.

Though many academic researcher centers today perform similar studies — molecular components have become commonplace in drug-response and disease-prediction studies — Ardais claims that its samples are more pure than those collected at typical research centers. Plus, the Lexington, Mass.-based firm said its BMS platform can enable other research centers performing similar studies to obtain Duke’s tissue samples and gene-expression data profiles.

“This new … repository will give researchers access to large, systematized collections of … biomaterials that can be standardized across a national network in coming years,” Kim Lyerly, director of the Duke Comprehensive Cancer Center, said in a statement this week.

Even as it broadens an ongoing collaboration with Duke, the deal represents a new business direction for Ardais. The firm’s “historical business model” called for it to oversee IRB-approved collections of tissue samples and attendant data — with the goal of licensing them out to third-party research labs and drug makers, according to CEO Don Hawthorne.

Since it was founded almost five years ago, Ardais has accumulated more than 200,000 tissue samples from some 16,000 patients. This repository, called Biomaterials and Information for Genomic Research, or BIGR, includes formalin-fixed and frozen samples linked to patients’ clinical data; tissue microarrays for high-throughput parallel analysis; molecular derivatives, such as RNA, DNA, and protein lysates; and immunohistochemistry services.

For example, Ardais would use the BIGR database to determine the potential of biological targets in a pharmaceutical company’s pipeline.

Ardais now sees its role as that of an enabler: It wants to use its experience creating and managing these kinds of repositories to help customers set up their own tissue databanks.

“The Ardais business model has switched from a sole focus on what ‘flows through the pipes’” — collecting and licensing tissue and other biospeciments — “to being focused more on ‘managing the pipes,’” or creating and managing the biospecimen repository, Hawthorne told Pharmacogenomics Reporter in a recent e-mail.

“It’s become quite clear that assisting various medical centers in the management of their biospecimens is a high need,” added Martin Ferguson, senior vice president of bioinformatics at Ardais.

Duke University Medical Center is Ardais’ first BMS customer, and the company has been collecting samples for the center since the beginning of March. The agreement will enable Duke to collect, archive, and use certain tissue samples and molecular data as part of a breast cancer study tied to its Sponsored Project Research Excellence, or SPORE, grant.

Hawthorne said the Duke deal is not a pilot program, and that Ardais is being paid for its services. He added the company has “a very, very active pipeline,” and said that “there are many institutions that are interested.”

Specifically, Ardais will work with Duke to develop an IRB protocol, and collaborate with radiologists, surgeons, and oncologists to identify patients that might qualify for a Duke study. Once a patient has been found, she is referred by her oncologist to undergo a radiology-guided core biopsy of her lump.

Soon after, a nurse asks the patient if she would like to participate in the clinical trial. She would then ask if the patient wouldn’t mind having additional blood samples drawn; or having two or three additional needle biopsies performed.

The patient would be told that these samples, which would become anonymized, would be used in the clinical trial if her diagnosis is positive.

The patient will probably be approached again if her physician plans to perform a resection or a lumpectomy, said Ferguson. That tissue would also be banked for additional research.

Though it is difficult to accurately say how many patients will likely participate in the program at Duke, Hawthorne said that the medical center enrolls 300 breast cancer patients annually.

Hawthorne said that these data, which will be stored at Duke, can be made available to other labs if the original customer wishes. “It’s completely up to the PIs,” he said. However, because this is a SPORE grant, Duke would be prohibited from sharing these data with a company, he added.

The BMS system will also manage the frozen tissue samples and their gene-expression data, RNA, DNA, and protein lysates. “I think over time it will become increasingly clear that it’s a broader, newer direction,” Hawthorne told Pharmacogenomics Reporter.

Hawthorne said he expects Ardais to raise additional venture capital since it drew $13.4 million in a Series C round of private-equity financing in February 2003. “I think we expect to go out and raise growth capital sometime in the next year,” he said. “But we’re fine for now.”

If the company does raise additional venture capital, it will be the first time in 14 months that it will do so.

The last investment, in February 2003, was a $13.4 million round led by a group of existing investors including the Kaufmann Fund, Advanced Technology Ventures, Advent Health Care and Life Sciences, EGS Healthcare Capital Partners, Bessemer Venture Partners, Pequot Private Equity Fund, BioVentures Investors, and Silicon Valley Bancshares.

— KL

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