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BioSeek Garners Milestone Payment and Validation from Dynavax for BioMap Tech

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BioSeek, the self-described “human systems biology company,” said last week that it has achieved a milestone and received an associated payment for an undisclosed amount in its collaboration with drug-discovery firm Dynavax Technologies.

The companies forged their drug-discovery collaboration in June 2003. Under the terms of the agreement, BioSeek was to analyze and characterize the activity of a novel family of TNF-a inhibitors known as thiazolopyrimidines, which Dynavax is developing for treatment of chronic inflammatory diseases. The agreement included potential milestone payments to BioSeek based on achievement of technical and commercial milestones, and royalties on sales of any products that might result from the collaboration.

According to last week’s announcement, BioSeek successfully characterized the biological activity of the compounds using BioMap, its proprietary cell-based drug-discovery technology that assays compounds against a variety of cells that mimic various inflammatory disease states.

The milestone payment announcement is the first public validation of BioMap from one of BioSeek’s drug-discovery collaborators — the only one that BioSeek has been allowed to disclose thus far in its five-year existence.

“We have collaborations with a number of biotechs and pharmas, and the bigger companies tend to be a little bit shy about what we say,” Peter Staple, BioSeek’s CEO, told Inside Bioassays last week. “We are in the process of expanding a number of those [collaborations]. I suspect that over time and probably in the near future, some larger ones would be announced.”

According to Dynavax’s website, its discovery program focuses primarily on developing products to treat and prevent allergies, infectious disease, cancer, and chronic inflammatory diseases.

Despite the disclosure of the partnership, even Dynavax remains tight-lipped about specifics. Jane Green, Dynavax’s vice president of corporate communications, last week declined to provide additional comment on the efficacy of the BioMap technology, adding that the company wished to say no more than it did in a statement released last week by BioSeek.

“BioSeek has provided us with important insights into the activity of our compounds,” Robert Coffman, Dynavax’s vice-president and chief scientific officer, said in the statement. “We are impressed with the disease-relevant information generated, relating to mechanism of action, and the quality of the interaction with the BioSeek team.”

BioSeek claims to take a “systems biology” approach to drug discovery, which it differentiates from so-called high-content screening. Its primary technology platform, BioMap, doesn’t really represent the use of one type of fluorescence cell-based assay, analysis algorithm, or a particular readout instrument, the company said.

“A lot of people are used to thinking about differentiating screening technology based on detection methods,” Staple said. “But in our case, I think what’s important and proprietary is the biology that goes in up front to create the systems themselves.

“The proprietary nature involves multiple cell types, multiple factors that activate the cells, and multiple readouts,” he added. “So it’s the multiplexing itself, both with the input and the output, which allows us to be different and proprietary. That allows us to look at a number of different things at the same time, unlike in a standard cell-based assay, where you’re kind of looking at one thing at a time.”

In a typical BioMap discovery program, different types of human primary cells are exposed to a series of conditions that approximate a disease state. This could be any number of natural immunological or other factors that a cell would be exposed to within the body during the course of disease.

BioSeek then assays compounds of interest against the cells, with the reasoning that the closer a cell is to the natural disease environment, the more relevant the information.

“The reason for developing these assays was understanding that in diseased tissues, the environment and cell types that are there are in a very different context than they typically are in high-throughput screening,” said Ellen Berg, BioSeek’s chief scientific officer and co-founder.

“We set out to design practical cell-based assays that would, in part, mimic aspects of disease biology,” Berg added. It is much like high-throughput disease tissue models. But because of the challenges of a high-throughput mode — incorporating every aspect of the biology in one system — we’ve developed a panel of systems that can be used together to give you a picture of how a compound is going to behave in a real disease environment.”

A great deal of the assays that are used in BioMap are enzyme-linked immunosorbent assays, although the company describes other possible assay types — including chimeric fluorescent proteins and semiconductor quantum dots — in its sole published US patent, No. 6,656,695.

The patent, as well as various papers published about BioMap, indicate that the company has used a Molecular Devices plate reader to conduct high-throughput readouts of the assays, although Berg says that the company uses many types of readout instruments, and is constantly evaluating new ones.

“Practically, we’re not limited,” Berg said. “We are generally looking for technologies that are high-throughput and robust. For example, we’ve been following with a lot of interest protein chips — but they’re just not ready for prime time. That may be a technology that we incorporate further, but those are not officially robust.”

BioSeek is also nurturing its own internal drug-discovery business, which Staple and Berg said focuses almost exclusively on inflammation, although it will likely be branching out into other areas — such as metabolic disease and cancer — for which the company sees the BioMap technology as a natural fit.

“We started out in inflammation,” Berg said. “It was the expertise of the people of the company, and it was a very large market. By profiling many different compounds and drugs through our systems, how-ever, we discovered that they could detect a number of mechanisms outside of inflammation — cardiovascular disease, statins, beta-blockers, calcium channels, et cetera.”

“We think of the models really as more immunology models since we’ve been able to identify these additional activities,” Staple added. “There are a number of diseases where inflammation or the immune system is actively involved. Metabolic disease is clearly one of those, and cancer is another. Cardiovascular disease is now being appreciated as having a very large inflammatory component.”

Privately owned BioSeek, which was founded in 2000, has already raised approximately $14.4 million in venture capital cash, with an announced $8.4 million round in 2002, and according to Staple, another unannounced $6 million in 2003.

In addition, in 2003 BioSeek was awarded a Phase II Small Business Innovation Research grant from the NIH worth approximately $770,000 over two years for a project entitled “High-throughput human cell system for compound screening.” That funding period ends May 2005.

The company has plans, though not immediate, for another round of financing in the future.

“We’re talking to investors currently,” Staple said. “We’re also working a lot on expanding our revenue base through partner profiling.

“We saw a very nice increase in revenues last year, the trend is continuing this year, and I think we’re looking at a combination of revenues from partners as well as equity financing,” he added. “There are a lot of opportunities to do non-diluted financing when you have a broadly applicable technology.”

— BB

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