A gut check for Big Pharma

SAN DIEGO—Microbiome specialist biotech company SecondGenome has announced an agreement with Janssen Biotech Inc., one of the JanssenPharmaceutical companies of Johnson & Johnson. The agreement focuses onmicrobiome drug discovery in ulcerative colitis, with the goal of advancingnovel drug targets, as well as discovering and understanding therapeuticmechanisms mediated by the bacterial ecosystem living within the human gut.

Under the terms of the agreement, Second Genome will receivean upfront payment and support for research activities conducted incollaboration with Janssen. Second Genome will also be eligible to receivepotential payments upon the achievement of certain research milestones. Janssenwill provide a guidance role, and the funding will come through the Johnson& Johnson Innovation Center and the Immunology Therapeutic Area withinJanssen Research & Development LLC.

The partnership's first goal will be gaining anunderstanding of or discovering a mechanistic role the microbiome plays inulcerative colitis. Then, the researchers will attempt to identify noveltargets based on these discoveries.

According to Dr. Miguel Barbosa, vice president and head ofImmunology Research & Scientific Partnership Strategy at Janssen Research& Development, the field of microbiome research is on the cusp of movingfrom pointing to associations between certain microbiota and disease states todefining causative relationships or identifying predisposing factors related todisease.

The microbiome is the bacterial ecosystem living within thehuman gut, as well as in the mouth, skin and elsewhere in and on the body. Itis estimated that the human microbiome consists of more than 100 trillionmicroorganisms that form a complex community of bacterial species that playvital roles in human health, including food digestion, synthesizing vitaminsand nutrients and preventing disease-causing bacteria from entering the body.

"A breakdown in the normal relationship between the humanimmune system and the bacterial communities that reside in the gut appears toplay an important role in development of the hallmark chronic inflammation ofulcerative colitis," said Dr. Susan Lynch, scientific advisor to Second Genome,director of the Colitis and Crohn's Disease Microbiome Research Core andassociate professor of gastroenterology at University of California, SanFrancisco, in a media statement about the agreement.

Prior to announcing their agreement, both partners hadrecognized the swell of interest in microbiome research in the past 12 to 18months, and the strong growth of scientific literature connecting themicrobiome to a number of disease areas.

"We saw a lot of compelling data, and an explosion of moreand more labs publishing in this area related to human disease and potentialmechanisms," says Barbosa.

"The question on the table has been the relevance of themicrobiome for pharmaceutical drug discovery," says Peter DiLaura, presidentand CEO of Second Genome. "The Janssen-Second Genome collaboration is the firstpharma-biotech deal in the space, and we believe it provides a strong validationthat the microbiome is increasingly understood to be relevant to Big Pharma."

Second Genome has developed a powerful proprietary platformfor mining the microbiome for potential targets. It is able to broadly profilemicrobiota associated with specific samples and analyze vast amount of datacollected this way using advanced computational tools. Janssen was attracted toSecond Genome because it had the right combination of these factors and amature platform seen as one of the leaders in the field.

Barbosa says this agreement with Second Genome plays intoJanssen's broader strategy of proactively entering areas of emerging scienceand investing in collaborations with companies and labs at the forefront inthose areas.

"I see our engagement with this area of emerging science asa reflection of Janssen's R&D commitment to treatment of autoimmunedisease, not just looking at current approaches but also identifying diseasemechanisms that could allow us to transform the way we treat illness," says Barbosa.

"We're excited to be the first company to take thisimportant step in translating microbiome science into therapeuticsapplications," says DiLaura.

Aside from applications in inflammation (and in ulcerativecolitis within this broad category), microbiome research and development alsoholds promise in metabolic disease, particularly in type 2 diabetes.