Just a gut feeling

LA JOLLA, Calif.—One year ago, Janssen Research & Development—a Johnson & Johnson company—launched three distinct collaborations with Second Genome and the University of California, San Francisco (UCSF), Vedanta Biosciences through the J&J Boston Center and a joint UCSF-University of Michigan partnership. All were to investigate microbiomes to combat gut diseases such as ulcerative colitis and irritable bowel disease (IBD), and all systems are still a go.

 

While Janssen says it is too premature to announce any results, the projects are proceeding as planned with the shared goal of discovering new therapies—and possibly a cure—for many digestive diseases, says Miguel Barbosa, Janssen R&D's head of immunology research and scientific partnership strategy.

 

Janssen R&D “has placed a strong emphasis on this area of research, entering into collaborative agreements with several academic and industry partners to investigate the microbiome and how it may inform future therapeutic development,” Barbosa tells DDNews.

 

“The microbiome has been recognized as an emerging area of science with high potential to identify novel mechanisms controlling inflammation, tolerance and/or susceptibility to disease, and therefore informing direct approaches to therapeutically address, cure and prevent immune-mediated inflammatory diseases,” Barbosa explains.

 

Over the past five years, Janssen has built a leadership position in microbiome science.

 

“We have strengthened our efforts through a network of collaborations that span academia with UCSF and the University of Michigan, and through the capabilities, technology and expertise of Vedanta and an exciting collaboration with Second Genome (announced June 5, 2013) is focused on establishing a causal link between unique microbial strains and human disease,” Barbosa shares.

 

“With an initial focus to explore the role of bacterial populations in ulcerative colitis (UC), future efforts will seek to develop actionable hypotheses leading to target validation and drug discovery,” he adds. “This research (with Second Genome) could lead to the discovery of new targets and novel therapeutics not only for UC and Crohn’s disease, but a broader set of inflammatory and autoimmune disorders. Our short-term goal with Second Genome is to identify microbes and their metabolites with a causal role in ulcerative colitis, while our long-term goal is to treat ulcerative colitis.”

 

Janssen’s collaboration with UCSF “is focused on understanding how an orally delivered commensal bacteria can modulate distal immune responses in the lungs,” Barbosa says. “The long-term objective is to develop innovative therapeutics for pulmonary diseases.”

 

The pharmaceutical industry has changed so much over the last 10 years that today partnerships are a key component to delivering next-generation therapeutic solutions, he notes.

 

With the goal of advancing novel drug targets, the agreement “is focused on therapeutic mechanisms in ulcerative colitis mediated by the bacterial ecosystem living within the human gut, referred to as the microbiome,” he says. Second Genome “will apply its microbiome modulation discovery platform to characterize the role of bacterial populations in ulcerative colitis.”

 

Peter DiLaura, president and CEO at Second Genome, has stated, “Foundational microbiome research over the past several years has demonstrated that alterations to the microbiome are central to the development of inflammation and metabolic disorders. The role of the microbiome in health and disease has arrived as a significant area of focus in pharmaceutical R&D. This collaboration with Janssen will identify mechanisms by which microbial populations in the gut have an impact.”

 

Under the terms of the agreement, Second Genome received an undisclosed upfront payment and support for research activities conducted by Second Genome in collaboration with Janssen. In addition, Second Genome is eligible to receive potential payments upon the achievement of certain research milestones. The research has been funded through the Johnson & Johnson Innovation Center and the Immunology Therapeutic Area within Janssen R&D.

 

The human microbiome is made up of more than 100 trillion microorganisms that live in our gut, mouth, skin and elsewhere in and on the body. These microbial communities play critical roles in supporting life and health, and are needed to digest food, prevent disease-causing bacteria from invading the body and synthesize essential nutrients and vitamins.

 

“A breakdown in the normal relationship between the human immune system and the bacterial communities that reside in the gut appears to play an important role in development of the hallmark chronic inflammation of ulcerative colitis,” stated Dr. Susan Lynch, scientific advisor to Second Genome, director of the Colitis and Crohn’s Disease Microbiome Research Core and associate professor of Gastroenterology at UCSF.

 

“Second Genome has a powerful platform to mine the microbiome for potential targets which have the potential to translate into effective therapeutics that dramatically impact patient health,” Lynch added.

 

On June 27, 2013, Janssen forged an alliance with Vedanta through the J&J Boston Innovation Center, where Janssen is working with a team of world-renowned experts in immunology and microbiology to support the advancement of a novel class of therapies that modulate pathways of interaction between the human microbiome and the human immune system, the company reported.

 

Johnson & Johnson Development Corp. has made an investment in Vedanta as part of a collaboration with the J&J Innovation Center in Boston to support the advancement of a novel class of therapies that modulate pathways of interaction between the human microbiome and the human immune system.

 

Vedanta’s programs are based on fundamental discoveries in the field of mucosal immunology. The discoveries illuminate mechanisms the immune system uses to differentiate between “good” and “bad” microbes, the company reports. When these mechanisms are impaired, autoimmune and inflammatory diseases result.

 

“We believe mining these mechanisms holds the key to developing a whole new class of immunotherapies that will act in ways distinct from existing drug classes,” said Ruslan Medzhitov, professor of Immunobiology at Yale University and co-founder and chair of the scientific advisory board of Vedanta. “The potential impact on human health is enormous, and we are just beginning to tap into that opportunity.”

 

Vedanta has developed a discovery platform to mine these unexplored mechanisms, Medzhitov said. The platform enables investigation of novel targets and discovery of immunomodulatory microbiome-derived compositions. Vedanta’s lead program, VE-202, is a novel therapy for the treatment of IBD and other autoimmune and inflammatory diseases.

 

John LaMattina, former president of Pfizer Global R&D and member of the board of directors of Vedanta stated, “Critically, in a field that is now frequently generating headlines on the basis of exciting basic research findings, Vedanta has moved beyond the initial discoveries and identified specific therapeutic compositions that we have advanced in preclinical work.”

 

Vedanta owns a “broad portfolio of foundational intellectual property that places the company in a strong position to develop a robust pipeline of therapies based on how the human immune system interacts with its microbial residents,” he said.

 

Bernat Olle, CEO of Vedanta, stated, “We are looking forward to working with the Johnson & Johnson Innovation center in Boston and the Janssen pharmaceutical companies to accelerate our research. The Immunology Therapeutic Area within Janssen shares a genuine interest in the human microbiome field.”

 

Janssen R&D is also engaged in a multilaboratory collaboration with UCSF and the University of Michigan that is focused on identifying the underlying mechanism of action of a novel immune-modulatory commensal bacteria.