Our Platform
Seres’ pioneering science, paired with powerful drug development and manufacturing capabilities, underpins its unique therapeutics platform.
Transforming rigorous scientific insights into groundbreaking new medicines
A robust body of research, which includes work by Seres and our collaborators, has revealed the integral role the gut microbiome plays in overall human health. Increasingly, the gut microbiome is understood as a pillar of essential functions such as protection against potential invaders, immune and inflammatory responses, metabolism, and neurological signaling.
Bacteria, a major component of the gut microbiome, can affect these various functions by producing metabolites and peptides that interact with other microbes and the host. Scientific understanding of the role of the microbiome and microbe-associated metabolites has advanced tremendously and is enabling the development of therapeutics that may treat a variety of serious diseases.
Over the past decade, Seres has pioneered the translation of microbiome insights into an entirely new class of potential new medicines. This includes the development and commercialization of the first-ever FDA-approved oral live biotherapeutic, VOWST™*.
Our live biotherapeutics are comprised of rationally selected consortia of bacteria in oral capsules that are designed and optimized to have specific functional pharmacological properties. This includes preventing infections, restoring epithelial barrier integrity, and modulating immune functions. We believe that these therapies could provide benefit to medically vulnerable populations that are at risk for bacterial infections and other potentially life-threatening complications.
*VOWST™ was sold to Nestlé Health Science in September 2024.
Studies show that live biotherapeutics can drive pharmacological effects across multiple pathways simultaneously.
Our approach:
Delivering a multifunctional
consortium of bacteria
The gastrointestinal (GI) microbiome consists of diverse bacteria that contribute to our metabolism and immune functions and have impacts throughout the body—protecting against numerous diseases including serious infections, chronic inflammatory and immune disease like UC, metabolic, and neurological conditions.
A properly functioning GI microbiome has the following properties:
Disruption of the following microbiome-modulated functions can lead to and aggravate infectious diseases:
At Seres, we optimize consortia of bacteria that are designed to modulate the functional properties of the gastrointestinal microbiome. These bacteria have the potential to prevent and treat infectious diseases via multiple effects including, for example, by changing the set of metabolites found in the gut to inhibit pathogen growth and protect the lining of the gut to prevent pathogens from entering the blood stream.
Loss of microbiome functions can lead to immune and inflammatory diseases, including some cancers:
At Seres, we optimize consortia of bacteria that are designed to modulate the functional properties of the gastrointestinal microbiome. These bacteria have the potential to modulate pathways that improve gut lining integrity, reduce inflammation and promote immune tolerance both locally in the gut and systemically.
At the heart of our approach are multifunctional consortia of bacteria that are designed to functionally interact with host cells and tissues to treat disease.
We use data from clinical studies to discover the microbes and microbe-associated metabolites that functionally interact with human cells and tissues to see if they can be targeted to treat infections and other diseases. We then utilize advanced computational tools and proprietary functional assays to design consortia of commensal bacteria that modulate these targets and act on multiple microbial and host functions.
Seres is harnessing these defined consortia, or collections, of bacteria to modulate function pathways in the gastrointestinal tract and systemically modulate microbiome function. Instead of targeting just one disease pathway, a benefit of using bacterial consortia is that they are multifunctional. This means they might have multiple pharmacological effects and modulate numerous functional pathways within the body to achieve therapeutic impact.
Our research strategy:
The Live Biotherapeutics
Engine
Seres has built an unprecedented Biotherapeutics Engine to design, test, and manufacture multifunctional bacterial consortia.
Live bioherapeutics engine
1. Microbiome biomarker discovery
As we begin development of a new therapeutic for a disease of interest, we gather insights from existing clinical studies and microbiome datasets. These datasets come from human subjects for the relevant patient population, a critical first step known as reverse translation. Starting with patient data allows us to identify and target drug development efforts to modulate microbiome functions that are clinically relevant to the disease. We deploy our proprietary, customized analytical tools to interrogate tissue samples, genomic and metabolomic data (revealing important bacterial functions and species), and findings from our and others’ human studies to discern which microbes and microbiome functions are altered in disease or predict a poor clinical outcome. These microbiome biomarkers define disease-relevant functional pathways that become our drug targets.
2. Consortia design
Next, we design leads for development: unique consortia of bacteria that can modulate the target microbiome functions defined by the biomarkers. We draw upon our extensive proprietary strain library of commensal (resident) human gut bacteria. Bacterial strains are selected for consortia based on an expansive repository of genomic and functional screening information, with each strain addressing multiple target functions. We iteratively evaluate candidate consortia in computational models for specific functional characteristics, including interactions with human cells and tissues, other species in the gut microbiome, and impacts on specific disease-relevant functional pathways.
3. Pharmacological validation
Once we have assembled consortia with the desired functional effects, we test their pharmacological properties in the laboratory using in vitro assays and disease-relevant animal models. For disease states and functions that are challenging to study, we have developed proprietary human tissue cell assays, including organoids, to replicate key aspects of the disease and test the effects of individual bacterial strains and therapeutic consortia. We use insights from these experiments to iteratively refine and finalize the bacteria comprising therapeutic consortia to define the drug candidate.
4. Advanced manufacturing and oral formulation
Finally, we manufacture bacterial consortia for evaluation in human clinical studies. Our in-house manufacturing organization integrates process development, current Good Manufacturing Practices (cGMP), Quality Control, and Quality Assurance. These capabilities allow us to deliver effective, high-quality, and consistent live biotherapeutics formulated for oral delivery.
5. Quality control and product safety
Our therapeutic candidates comprise highly purified consortia of targeted human commensal bacteria, manufactured under current Good Manufacturing Practices (cGMP) conditions and quality controlled using stringent standards to ensure product quality and consistency.
