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CORPORATE PROFILE Biobusiness Making Sense of Small Molecules With a Focus on Data Processing, Metabolon Detects Metabolomic Signals Amid Mass Spec Noise Tracy Vence There are some biological phenomena neither the genome nor transcriptome can fully explain. The feld of metabolomics—the study of small-molecule metabolites—seeks to fll those knowledge gaps, giving researchers a glimpse of what's actually happening within complex systems. When it was founded in 2000, Metabolon was a pioneer in this fedgling feld. With time, the private company has carved a signifcant niche in the global metabolomics market, and is now shifting focus from an initial emphasis on technology-driven biomarker discovery to the development and commercialization of diagnostics. The Durham, NC-based firm, which rounded up its frst fnancing in 2003, is now 140 employees strong. Roughly half its staffers are Ph.D. scientists who are working to measure, identify, and quantitate all of the small molecules in biological systems. "We do what's called 'global analysis,'" CEO John Ryals, Ph.D., tells GEN. "In our view, it's really…a profling technology that would be analogous to a gene-expression chip, for example, where you could do unbiased analysis of small molecules and fgure out what's going on." Metabolon scientists use mass spectrometry and sophisticated data analysis techniques to deconstruct the chemical fngerprints left by cellular processes. With mass spec, "There's way more noise than there is signal," Dr. Ryals says. "So we've developed about 2 million lines of specialty code so that we can take this very complex signal coming out of a mass spec and be able to eliminate the noise, really zero in on the signal, and then interpret the signal." Taking this approach, Metabolon has serviced a variety of clients spanning from industry to academia. Typical projects include mode-of-action investigations for pharma and studies on everything from drought resistance in resurrection plants to cancer cell metabolism for academic researchers, the frm's chief executive notes. "Maybe they have genomic data or transcriptional data that they are having diffculty fguring out. You can use our approach to really narrow the focus as to what the issues are," Dr. Ryals explains. The company has also launched a diagnostic test based on its metabolomic technology. The single-draw blood test pairs an evaluation of three metabolites with an algorithm to detect patient insulin levels. It's currently licensed to Richmond, VA-based Health Diagnostics Laboratory, which markets the test as part of its Diabetes Prevention & Management Panel. And there are more tests in the works. Aside from type 2 diabetes and other obesityrelated conditions, the company is planning to roll out diagnostics for cancers, including prostate, bladder, and renal cell carcinoma. Both type 2 diabetes and cancer "are wellknown metabolic disease areas," Dr. Ryals notes. "The basic idea is to try to help the general practitioner or the family practice doc be able to better diagnose and get into early interventions with patients," he adds. Metabolon has also set its R&D; sights on the microbiome. "Humans actually maintain about a hundred molecules in their blood at homeostatic levels being contributed from the gut microfora," Dr. Ryals says. "We know that because humans don't have the capability of making these things." Some of these compounds, he adds, have already been implicated in everything from obesity to autism spectrum disor- der, presenting signifcant potential for future diagnostic-minded efforts. The feld of metabolomics stands to gain from emerging interest in the microbiome and its effects. To Dr. Ryal's mind, such interest shows researchers are again looking to metabolites as key indicators of health and disease. "Because of the maturation of molecular biology and recombinant DNA, the world of biology has become very gene-centric," he says. "But a lot of the problems we see, [though] they may be associated with genetics, when they actually manifest themselves it's really about metabolism." VITALsigns Metabolon Location 617 Davis Drive, Suite 400 Durham, NC 27713 Phone (919) 572-1711 Website www.metabolon.com Principal John Ryals CEO Number of Employees 140 Focus Metabolon says that its metabolomics-driven approach enables the identifcation of biomarkers useful for the development of a wide range of diagnostics and provides insight into complex biochemical processes. Metabolon uses mass spectrometry and computational approaches to perform global metabolomics analyses for biomarker discovery and diagnostic development, among other applications. NEWS Inside Industry > Roche Buys CMI, Creates Hematology Dx Hub In $220M+ Deal Roche has acquired Constitution Medical Investors (CMI) for $220 million up-front plus an undisclosed amount in potential payments tied to milestones, in a deal the pharma giant reasons will increase and enhance Roche Diagnostics' presence in the laboratory hematology testing business. CMI, Roche said, will evolve into Roche Diagnostics' center of excellence for hematology products, which now include a testing system in development that is designed to provide faster and more accurate diagnosis of blood-related diseases, such as anemia and leukemia. > Leica Biosystems Nabs Kreatech Leica Biosystems has acquired molecular diagnostics frm Kreatech Diagnostics, a provider of DNA fuorescent in situ 12 | hybridization probes and target-labeling reagents for microarrays, for an undisclosed price. Leica Biosystems focuses on workfow solutions and automation with the aim of advancing cancer diagnostics. Kreatech will join Leica Biosystems' Advanced Staining business unit based in Newcastle-upon-Tyne, U.K. The combined business will develop targeted biomarker menus for Leica platforms. > Nile Therapeutics to Acquire Capricor Capricor has agreed to be acquired by Nile Therapeutics for an undisclosed price, in a deal that creates a publicly traded drug developer that focuses on preventing and treating heart disease through regenerative medicine. The combined company, to be called Capricor Therapeutics, will be led by August 2013 | GENengnews.com | Genetic Engineering & Biotechnology News the management team of the current privately held Capricor, with CEO Linda Marban, Ph.D., holding the same position with the new company. Capricor said the new company will ofer Nile's chimeric peptide cenderitide, a clinical-stage drug intended to treat patients following hospital discharge from acute episodes of heart failure, while continuing the acquired company's development of cardiac stem cell therapeutics to repair damaged heart muscle. > Xoma Hands Off Perindopril Franchise to Startup Launched by Former Employees Xoma has transferred U.S. development and commercialization rights for its perindopril franchise to Symplmed Pharmaceuticals, in return for an equity stake in Symplmed of undisclosed percentage, and up to double-digit royalties on sales of a drug containing perindopril arginine and amlodipine besylate, subject to the fxed-dose combination (FDC) being approved by FDA. The FDC is marketed in 91 countries outside the U.S. by Servier, under the name Coveram®. Symplmed said it intends to complete a New Drug Application for the FDC and submit it to the FDA by year's end. At that point, Symplmed would pay all future FDC development costs, while Xoma would have no further fnancial obligations related to the FDC product or Symplmed operations. Three former Xoma employees cofounded Symplmed: Erik Emerson, who is now its president and CEO; Jefrey Feldstein, M.D., now its senior vp and CMO; and August J. Troendle, M.D., a director of the company and the founder and CEO of the CRO Medpace. n