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OGT's Protein Array at Heart of Sengenics Deal, Test-Development Programs

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Oxford Gene Technology, a UK firm perhaps better known for its menu of chromosomal microarrays and foundational array IP, has seen its protein array platform emerge from the shadows in recent weeks after signing an agreement that gives its main partner in Asia the ability to offer the arrays directly.

In addition, OGT recently provided an update on tests that have been developed, in part, using the platform, such as an assay for systemic lupus erythematosus.

OGT gained its protein array platform in 2009 when it acquired Sense Proteomic, a University of Cambridge spinout that specialized in arrays featuring fully functional, correctly folded proteins (BAN 3/17/2009). At the time of the deal, OGT framed the acquisition as a step toward building its internal biomarker discovery and diagnostic development program, noting Sense's existing programs related to prostate cancer and SLE.

Since OGT acquired Sense, though, the company has offered few details about the technology's development and use, both internally and with partners. This week, however, Arif Anwar, director of Kuala Lumpur, Malaysia-based Sengenics, said that OGT's protein arrays are increasingly being used by pharmaceutical and biotechnology companies, as well as researchers, for a variety of purposes.

Anwar told BioArray News that Sengenics has run more than 30 projects in the past few years using OGT's protein array platform, and that the "results have been very good," with some partners moving projects downstream into diagnostic development, creating panels based on markers discovered with OGT's chip.

To date, the samples in those projects have been processed at OGT's headquarters in Oxford. But earlier this month Sengenics announced that as of April 15 it would begin offering OGT's protein arrays as a service from its own laboratories in Kuala Lumpur. Anwar said that Sengenics will open a second site in Singapore in the second half of the year that will also offer the OGT protein array.

Both facilities will use the chip as part of a global cancer biomarker discovery and clinical trial immuno-response monitoring service, he said. And in establishing those two new facilities, Sengenics will become the only firm in the world that is able to run OGT's protein arrays, outside of OGT itself.

Sengenics has been OGT's partner in Asia since the two firms signed a deal in 2009. Two years later, the company began offering a number of chromosomal microarray services using OGT microarrays (BAN 7/26/2011). Anwar said that Sengenics has been working closely with OGT to transfer its protein array technology to its labs.

When it acquired Sense, OGT disclosed that its protein arrays consist of sets of human proteins immobilized onto a streptavidin-coated surface, using a biotin carboxyl carrier protein tag that is biotinylated only when correctly folded. The firm claims that biotinylation acts as an indicator of protein folding, meaning that only biotinylated – and therefore correctly folded – proteins are attached to the slide surface.

Anwar said these properties have attracted Sengenics' clients in Asia and the Middle East to the platform, since "every protein is perfectly folded and functional." While customers have the ability to design arrays containing their proteins of interest, all of Sengenics' customers to date have used the firm's catalog array, which features 1,636 full-length proteins targeted toward markers associated with cancer and autoimmune diseases, he said.

Anwar noted that demand comes from a variety of sources, and that Sengenics' protein array customers fall mainly into three categories: researchers from academic groups working on key diseases to identify early biomarkers; pharmaceutical and biotechnology companies interested in studying adverse drug reactions; and microbiologists doing bacterial research related to infectious diseases and vaccine development.

The Biomarkers Business

John Anson, executive vice president of R&D at OGT, said that the firm's protein array platform has been "highly successful in identifying promising diagnostic signatures for cancers and autoimmune diseases" and that the agreement with Sengenics was part of a company effort to "better serve the Asian market."

At the same time, Anson described OGT's protein array platform as one of the "next-generation technologies" it is using to advance its internal biomarker discovery and development programs.

Anson said that since the firm acquired Sense, it has invested in increasing the arrays' protein content by a quarter, while also improving assay reproducibility, "ensuring that the CVs within a study are less than 2 percent for normalized data."

Using the arrays and other technologies at its disposal, Anson said that OGT has amassed a "portfolio of exciting biomarkers for early disease detection" for three main indications: prostate cancer, colorectal cancer, and SLE.

Of these programs, Anson said that the firm's panel for SLE was developed directly using the firm's protein array technology, and that it "offers significantly improved disease detection compared to existing tests."

According to OGT's website, the SLE panel has already undergone three independent analytical validation studies on European, Afro-Caribbean, and confounding disease cohorts and is currently in late-stage analytical validation. To date, more than 640 samples have been analyzed in the course of four different studies, OGT said.

As for the path forward for its tests, Anson said that OGT maintains "clear development and commercialization strategies" for each of its biomarker programs, relying on its own service labs and potential outlicensing to specialist moleculer diagnostic companies. He did not elaborate.

Besides SLE, the company's prostate cancer program continues to advance. OGT announced last week in a statement that the Institute of Cancer Research, London, had granted it a license to develop a panel of diagnostic and prognostic prostate cancer microRNA biomarkers into a new assay.

That license is the result of a three-year collaboration, under which ICR and OGT discovered new miRNA biomarkers with a range of applications for the diagnosis, prognosis, treatment planning, and monitoring of prostate cancer, the firm said.

According to OGT, the microRNA markers in question have a specificity of over 90 percent and have the potential to be used not only to identify prostate cancer but also to assess its aggressiveness. Knowing the aggressiveness of an individual case of prostate cancer could help physicians tailor their treatments to specific patients, whereas current practices can lead to the removal of the prostate and chemotherapy, even though many patients may not require such excessive treatments, the firm claimed.

OGT also noted that it is evaluating the panel in blood and urine samples, and efforts to translate it to a blood-based PCR test have shown "very encouraging results."

Anson said that OGT used its microarray platforms to discover the markers, but that the PCR assay is "likely to form the basis for further validation and commercialization."

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