Second Genome Inc. is partnering with Pfizer Inc. on a large observational study exploring the relationship between the trillions of microorganisms comprising the human microbiome and obesity and metabolic disorders.

The collaboration marks Second Genome's second big pharma deal, following its 2013 agreement with the Johnson & Johnson Innovation Center and Janssen Research & Development LLC to discover drugs for ulcerative colitis. (See BioWorld Today, June 6, 2013.)

Second Genome isn't disclosing financial details of the agreement, but the company's CEO and president, Peter DiLaura, told BioWorld Today that support provided by the partnerships will help it advance its own programs, focused on type II diabetes and inflammatory bowel disease, into the clinic by next year.

The South San Francisco-based company's microbiome modulation technology can help generate and evaluate small-molecule therapeutics that alter microbial communities in the body to influence health and disease.

The observational study now under way is unprecedented in its scope, said DiLaura.

"The objective," he said, "is to fundamentally advance our understanding of metabolic disease through the microbiome lens, so we can get some new perspective on obesity and type II diabetes."

Second Genome and Pfizer will analyze the microbiomes of 900 people in varying states of health recruited by Massachusetts General Hospital's cardiology division. Another study of the group resulted in the finding of a gene conferring resistance to the development of diabetes, work documented in the March 2014 issue of Nature Genetics.

Early studies have suggested interesting correlations between the diverse microbial world, or microbiome, and disease. But, as the science has evolved, linking changes in the composition of gut microbes to metabolic conditions such as obesity and type 2 diabetes, pharmaceutical companies have come to recognize that "if you ignore the microbiome in drug discovery, you do so at your own peril," DiLaura said.

Recent microbiome transplant studies have demonstrated that introduction of specific microbes can influence host biology to drive weight loss or gain, suggesting the microbiome may be a therapeutic target for obesity treatments. "The challenge for drug discovery is getting to that mechanistic interaction between the microbiome and host so you can get to novel targets and develop new therapies against those targets," said DiLaura.

The opportunities for drugs that can capably address the rising prevalence of obesity and associated metabolic conditions is increasing rapidly. Obesity and diabetes rates have almost doubled since 1980 worldwide, according to the World Health Organization.

"Understanding the complex set of interactions between the gut microbes in obese and non-obese individuals is critical to our research in metabolic disease," said Barbara Sosnowski, vice president, external R&D innovation at Pfizer.

Underscoring the trend, as recently as April, Pfizer was seeking a new head of its microbiome research group to "develop research programs and novel candidates for inflammatory and autoimmune diseases with a special emphasis in inflammatory bowel diseases and mucosal immunology," according to a job listed on the company's website.

Second Genome has raised about $13 million to date, the majority of which came in an $11.5 million series A round funded by Advanced Technology Ventures, Morgenthaler Ventures, Wavepoint Ventures and Seraph Group. Individual investors, such as company co-founder and biotech veteran Corey Goodman, funded a $1.5 million seed round before that.

The microbiome field is growing fast, attracting ever more interest from both pharma and investors. On May 1, Paris-based Enterome Bioscience SA said it raised €10 million (US$13.9 million) in the first tranche of a series B to develop research biomarkers, companion diagnostics and therapeutics for inflammatory bowel and metabolic disorders. (See story in this issue.)

Meanwhile, start-ups such as the J&J-backed Vedanta Biosciences Inc., of Boston, and Seres Health Inc. have also attracted attention as they have explored new ways to understand and modify the microbiome. (See BioWorld Today, Dec. 30, 2013.)

Carrying the science ahead will take a strong team, and Second Genome, which today operates with 19 employees, is still growing.

The company is looking for four new employees, including an immunologist and a microbiologist, DiLaura said. "It's important to be able to approach the science from an integrated perspective."

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