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Biolog Wins More NIH Funding for Cell Array Tech; Delays Mammalian Version

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Hayward, Calif.-based Biolog has garnered another grant from the National Institutes of Health for a new application — this time in the area of antimicrobial drug development — for its Phenotype Microarray cellular array technology.

The additional $450,000 of funding will augment the approximately $2 million in separate grants that Biolog has received in the past three months to support the development of the Phenotype Microarray for applications ranging from detecting bioterrorism agents to functional genomic studies on yeast, Saccharomyces cerevisae.

Biolog also has approximately $2.5 million rolling in from a Phase II Small Business Innovation Research grant awarded last year by the NIH to further develop mammalian versions of its Phenotype Microarrays for predictive toxicology applications. That money was also expected to help bring the mammalian cell arrays to market as the first products of their kind as early as the first quarter of this year.

However, the official launch of the mammalian cell array technology has been delayed at least until next quarter, Tim Mullane, Biolog’s president and CEO, told Inside Bioassays last week.

“We’re about three months behind right now,” Mullane added. “We’re really targeting, we think, the early summer for the first six. Then we plan to have eight out by September and two more arrays out by the end of January next year.”

Last October, Mullane said that if everything goes according to plan, he expected that the arrays were going to be commercially available before the end of March this year, with anticipated applications in quality control of cells in cell-based drug screening, as well as in basic research (see Inside Bioassays, 10/19/2004).

Although Mullane declined to provide a detailed reason for the delay, he indicated that Biolog is still making good progress with the mammalian cell arrays, and that the delay was not a major concern for the company.

“We have six done right now … under the Phase I portion of the grant,” Mullane said. “We’ve been a little bit behind — and that’s for some operational reasons I won’t go into — but it’s really simple to fix.”

According to Mullane, each array will be applicable across several different cell lines, and will contain a panel of assays to probe different aspects of cell function. “The first six will have a couple of metabolic assays in there, and four chemical assays,” Mullane said.

In the meantime, Biolog continues to rack up funding from the NIH for a variety of applications on its existing Phenotype Microarray product lines, most of which comprise arrays of bacterial, fungal, or yeast cells.

In December, Biolog announced it had been awarded three grants from the NIH — including a $650,000 portion of the Phase II toxicology development grant — worth a total of about $2 million.

The first grant, an SBIR for about $920,000, was awarded under the auspices of the National Institute of Allergy and Infectious Diseases to develop a Phenotype Microarray system for detecting possible bioterrorism agents.

“And they go beyond the standard [bioterrorism agents] that everybody hears about,” Mullane said. “There are other ones, as well, that our technology is really well-suited for. They want us to make it faster, and to miniaturize it if we can.”

The other awards were Small Business Technology Transfer grants. The first, for about $277,000, was awarded to help Biolog develop its technology for the analysis of what are sometimes referred to as “fastidious pathogens.” According to Mullane, these are primarily food pathogens that are very difficult to culture and would be conducive to analysis with Phenotype Microarrays.

The second STTR grant is for approximately $123,000 to “phenotype the entire genome of S. cerevisae, with Johns Hopkins’ yeast genome,” Mullane said.

The most recent award, announced two weeks ago, was for $451,000, and will be used to de-velop the Phenotype Microarray as a tool to evaluate biologically active compounds using Staphylococcus aureus as the model organism.

“The most recent grant is very similar to the one for human toxicology — but it’s for antimicrobics,” Mullane said. “Instead of having a tissue type represented as in a human cell assay, you would have a microbial model cell line, and then run these chemicals against it.”

Mullane said that Biolog will screen 150 to 200 known chemicals against an S. aureus cellular array in order to develop a database that can be subsequently used for antimicrobial evaluation. Pharmaceutical and biotech companies could then add profiles of chemicals from their libraries to the database to make it a living, breathing resource.

“Our technology is based on cellular respiration, and we believe it is a universal reporter system for any cell,” Mullane said of the Phenotype Microarray’s broad applicability. “It’s measuring cell respiration, and cells naturally prefer to use respiration to generate energy, over fermentation or other methods.

“You can apply that in multiple areas,” Mullane added. “Our first products were designed to measure cell respiration in different carbon-based assays in bacteria and fungi, and develop a pattern in those assays, and that pattern is compared to a database of patterns that gives you identification. So we have a very broad-based identification product line that’s used in a number of markets, and it identifies a very large number of bacteria and fungi — about 2,000.”

From there, Mullane said, Biolog began to broaden the number of assays — moving from only carbon-utilization assays to assays for a number of different biochemical pathways and biosynthetic pathways.

“We started in bacteria, expanded it to fungi, and we’ve begun working with human cell lines with the same universal reporter mechanism, but using different chemistry than we use with microbes,” Mullane said.

Despite the early success of its microbial-, fungal-, and yeast-based Phenotype Microarrays, the mammalian Phenotype Microarrays — especially those using human cells — may be quite a boon for Biolog. When asked if these arrays represented the biggest potential source of revenue for Biolog down the road, Mullane said that he thinks “they will be a big bonus to the company.”

As Inside Bioassays reported in October, Biolog does have several companies beta-testing the mammalian arrays. Mullane declined to identify those customers then, and little had changed as of last week.

“It’s because of [new drug applications] — what they’re doing, they just don’t want us talking about it,” he said.

— BB

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