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Startup Focus: Stemina Eyes Dx Future through Stem Cells-Metabolomics Approach

By Tony Fong

NEW YORK (GenomeWeb News) – Leveraging one of the newer 'omics fields along with stem cell technology, start-up firm Stemina Biomarker Discovery is looking to accelerate its work at developing metabolomic biomarkers for drug screening and efficacy and the detection of diseases.

Earlier this week, the Madison, Wis., company and Agilent Technologies announced a partnership in which Agilent will provide Stemina with instruments and software to help hasten its research.

In return Agilent strengthens its presence in a market in a market that a company official called a "major growth area" for the firm.

Under the informal agreement, Agilent is donating a 6530 Q-TOF mass spectrometer, a 1290 Infinity UHPLC platform, and Mass Profiler Profession software for analysis of metabolomic data.

Formed in 2007 and using technology and methods developed by Gabriela Cezar, an assistant professor of animal sciences and human oncology at the University of Wisconsin, Stemina is "at the crossroads of stem cells and metabolomics," company CEO, President, and Co-founder Elizabeth Donley told GenomeWeb Daily News this week.

In Stemina's workflow, stem cell technology is used to create cells that are physiologically relevant, and then the cells' metabolites are investigated to determine which ones are over- or underexpressed in response to toxicants or disease states.

While using stem cells allows Stemina to "make the tissue type of interest. It's an all-human system," and allows the firm to build "the best potential in vitro environment to study a particular question," and metabolomics allows for research that is closer to the phenotypic level than other approaches, Donley said.

"When you look at genomic outputs, and even proteomic outputs, you have a number of steps before you get to the expressed phenotype," she said. "You can have a gene and it may or may not actually be part of who you are at the end of the day. For example, you can have the BRCA1 gene and never get breast cancer.

"The thing we like about metabolomics is that it's what's happening in real time," she said.

Stemina's first commercial launch was a service using undifferentiated human embryonic stems cells to screen for the effects of drugs and chemical entities on developing human embryos.

The service, called devTox assay, is also drawing interest as an alternative to animal testing. "There is agreement with the EU particularly, but momentum is growing in the US as well, that addition toxicity testing should be conducted on non-animal in silico predictions and in vitro tests, for both financial and animal welfare reasons," Donley said.

Stemina's work in this area was one drawing point for Agilent, said Ken Imatani, Agilent's marketing manager for TOF/Q-TOF. Worldwide, metabolomics is about a $100 million market, he estimated, with most of it, for Agilent at least, in the academic and government sectors.

"Strategically, it's important for us to have this technology move from where it is in terms of some of the academic settings toward some applications in pharmaceutical areas," he said. "Pharma companies might over time adopt this because they would have the motivation to do that."

Metabolomics is still a comparatively small part of Agilent's business, but "it's one of the fastest growing parts of our business right now, so we're paying a lot of attention to it," Imatani said. "It's not a large market yet, but it's growing rapidly, and a growing number of researchers are getting some very promising results, so from our perspective there's more money falling into it and probably will [grow faster] as time goes on than some of the other markets that we serve."

Donley declined to name customers of the devTox service, but said they fall into four categories: pharma, chemical companies, cosmetic firms, and government agencies.

Stemina also is developing biomarkers for autism. According to Donley, co-founder and Chief Scientific Officer Gabriela Cezar was screening valproic acid, an anti-epilectic drug that has been linked to autism in children. In the process, Cezar "used the physiologically relevant neuro precursors and mature neural cells, dosed them with valproic acid, and hypothesized that she would be able to see those same biomarkers overexpressed in the brains of autistic kids," Donley said.

When she analyzed post-mortem brain tissue from autistic kids, that's exactly what she saw.

Cezar has filed a patent application with the US Patent and Trademark Office covering five specific biomarkers as well as broader claims for small molecules involved in five pathways in the brain, and a method for identifying metabolic signatures characteristic of autism.

"It is a provisional application, so we anticipate expanding the specific biomarkers with work we are doing over the next year before converting to a utility application," Donley said.

The goal is to develop the biomarkers as a diagnostic screen for autism. Currently, no reliable screen for the disorder exists, and diagnosis is done based on a child's behavior, meaning diagnosis won't occur until later in a child's development.

"The idea is to build a newborn screen that can be done right at birth," Donley said.

In addition, Stemina is conducting research directed at glioblastoma multiforme — the most common and most aggressive form of primary brain tumor in humans — under a contract with the National Cancer Institute. Stemina has identified pre-candidate stem cell metabolic biomarkers and has created an efficacy screen based on those biomarkers to determine which drug therapies are most effective in killing cancer stem cells.

The company is awaiting word from NCI on a phase II contract in which the screen would be taken from the dish to actual patients.

Because metabolomics is still a new and developing field, Stemina has few competitors. Its two biggest rivals, according to Donley, are Metabolon and BG Medicine. Phenomenome, however, has metabolomic research directed at Alzheimer's disease and colon cancer, and Molecular Biometrics is doing metabolomic-based work in reproductive health, Parkinson's disease, and pulmonary health.

Numerous pharmaceutical firms, including Novartis, Roche, Abbott, Bayer, Bristol-Meyers Squibb, and Pfizer have metabolomics programs, also.

Stemina's competitive advantage, Donley said, "is our program and exclusive license to patents filed on the combination of stem cells and differentiated cells, such as heart and neural in combination with metabolomics for drug screening and drug development."

The new additional tools from Agilent are expected to accelerate Stemina's programs. Stemina will now have three Q-TOF platforms, each outfitted with the 1290 Infinity UHPLC on the front end.

The company has raised about $2.8 million from angel funding, and is currently in the midst of a $3 million Series A round. About $1.2 million has been raised in that round, and Donley expects to close on the remaining funds in the next three months.

Stemina has not explored the venture capital market yet, but that may change if the company "builds momentum" on its screens and the biomarkers under development turn out to be robust, Donley said.

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