Small entities; big implications

 

“In each of these target therapeutic areas, we have sought to identify the leading experts from around the world with whom Seres can collaborate—sharing capability and expertise—and ultimately accelerating our R&D efforts,” says Dr. David Cook, executive vice president of research and development and chief scientific officer at Seres. “We do so by closely following the scientific literature and networking with thought leaders through our scientific advisory board and at scientific conferences.”

 

“Academic research into the microbiome continues to progress at an incredible rate with high-profile papers published each week. Therefore, we will continue to evaluate future collaborations with leading experts in areas of interest to the company,” says Cook.

 

Seres’ multiyear collaboration with microbiome clinical scientists from UPenn includes separate efforts in inflammatory bowel diseases (IBD) and rare metabolic diseases to support the development of novel treatment approaches. Under the terms of the agreement, UPenn professors Dr. Gary D. Wu and Dr. James Lewis plan to conduct investigator-sponsored research evaluating rationally designed bacterial compositions for patients with ulcerative colitis. The UPenn team will conduct a separate study to evaluate the role of the microbiome in urea cycle disorders and certain other rare genetic metabolic diseases, building upon previous studies suggesting the toxic levels of ammonia in these patients may be reduced by altering the gut microbiome.

 

As part of the collaboration, Seres will provide UPenn researchers access to their proprietary library of 14,000 gut-derived bacterial strains, and will provide scientific, manufacturing and regulatory expertise to assist UPenn. Seres will conduct metagenomic and other analyses on patient samples, which will inform the development of future rationally designed microbiome therapeutics.

 

“As clinical researchers, we are eager to translate our scientific and clinical insights into effective new therapeutics for our patients,” said Wu in a news release about the collaboration with Seres. “We are very pleased to collaborate with Seres as we move this work forward.”

 

The multiyear sponsored research agreement between Seres and MSK will support the translation of microbiome discoveries from MSK laboratories into first-in-field therapeutics across multiple new cancer indications in which the microbiome may play a critical role. Seres will collaborate with MSK investigators to study patient samples from MSK clinical studies, generating microbiome metagenomic signatures as well as other clinical data that are expected to aid in the design of novel microbiome therapeutics. The agreement also provides Seres with a global license to MSK’s intellectual property related to the use of bacterial compositions in treating hematopoietic stem cell transplantation (HSCT) patients and related areas.

 

The team of MSK investigators, led by Dr. Marcel van den Brink, has conducted prior clinical studies evaluating the relationship between the microbiome and patient outcomes in various diseases. The investigators have published clinical studies demonstrating a relationship between the diversity and composition of the microbiome in patients receiving HSCT and their increased risk of bacterial infections and graft versus host disease, both of which contribute to overall mortality from the process. Seres is currently developing SER-155, a rationally designed, preclinical-stage therapeutic candidate comprised of in-vitro cultured bacterial species that aims to improve morbidity and mortality outcomes in HSCT patients.

 

The collaboration also includes MSK providing Seres with access to published and unpublished microbiome data from a prior investigator-sponsored research study conducted in patients receiving hematopoietic stem cell transplants. Seres will then perform an analysis of microbiome metagenomic signatures as well as other clinical data analyses that are expected to aid in the design of novel microbiome therapeutics.

 

Additionally, the collaboration will include researchers from both Seres and MSK working together to identify ways to use microbiome therapeutics to improve the efficacy and safety of immuno-oncology drugs including checkpoint inhibitors.

 

“This research builds upon a recent MSK publication which describes, for the first time, the important role of the microbiome in the development of colitis in patients and related preclinical work showing that the microbiome can enhance the antitumor efficacy of checkpoint inhibitors,” Cook notes.

 

Seres’ partnership with MGH will support translational research focused on identifying microbiome therapeutics for obesity and metabolic syndrome. Under the terms of the agreement, Seres will help fund a placebo-controlled, proof-of-concept clinical study to evaluate the impact of fecal microbiota transplantation (FMT) derived from lean individuals on the body weight and glycemic control of adults suffering from clinically significant obesity and metabolic disorders, including insulin resistance and metabolic syndrome. Per the terms of the agreement, Seres will then be able to analyze patient samples to determine metagenomic signatures, bacterial metabolites and other key clinical biomarkers that are expected to inform the design of microbiome therapeutics for treatment of obesity and associated metabolic disease.

 

“The lead researchers at MGH are currently conducting groundbreaking research to elucidate the impact of gut bacteria on body weight and other metabolic parameters, which Seres believes will provide critical insights to support the development of new microbiome therapeutics for obesity and metabolic conditions,” Cook tells DDNews.

 

“We believe these collaborations will accelerate our goal of bringing significant new therapies to patients with serious diseases,” he adds. “Partnering with leading academic scientists gives us access to some of the best minds in the field and an ability to have a closer relationship to patients, so that our discovery pipeline is generating drugs with a higher probability of clinical success.”