We are discovering and developing therapies designed to act on the gut-body network. Our therapies are based on our growing understanding of the central role of the gut in modulating immune activity throughout the body and the important role of microbes as key modulators of the gut-body network.
The Gut-Body Network
The gut-body network represents the connections of the gut to all organs and tissues, which enables the gut to exert a significant level of control over the body’s immune and biological systems. The centrality of the gut-body network to the immune system has only recently become appreciated, and modern medicine and drug discovery have largely overlooked the importance of the gut-body network in fighting disease. We believe we have the potential to use the unexplored biology of the gut-body network to develop novel therapies that could transform the treatment of many major diseases.
The gut is the largest part of the immune system and is a central hub of the body’s network of lymphatic vessels. Immune cells from around the body circulate via these lymphatic vessels through the tissues of the gut where they are conditioned by exposure to the many antigens and immunomodulatory agents that continuously pass through the gut. These conditioned immune cells can then impact disease and health at all sites of the body. Microbes, in particular, have the ability to condition immune cells in the gut.
We are developing orally-delivered pharmaceutical compositions of specific strains of naturally-occurring microbes derived from a single clone, which we refer to as monoclonal microbials. Monoclonal microbials are designed to act on the gut-body network. In preclinical studies, we have observed that specific monoclonal microbials can downregulate or upregulate immune responses throughout the body by acting on the gut-body network with naturally-evolved pharmacology.
We believe that monoclonal microbials exert their effects through interactions with host immune cells as they pass through the gut. We believe our monoclonal microbials are likely to be well tolerated, given that they are single strains of naturally-evolved human commensal microbes that act on the gut-body network without significant risk of systemic exposure. Their ability to exert integrated effects on multiple pathways via convenient oral delivery drives the potential to impact diseases in ways not addressed by single-target therapies. These properties could present significant advantages over existing therapies.
Monoclonal Microbial Three Step Process
- Sampling of microbes in the gut by macrophages and dendritic cells
- Conditioning of T-cells by dendritic cells and macrophages in the lymph node
- Migration of conditioned T-cells throughout the body
We have developed an integrated platform designed to identify individual strains of microbes capable of modulating the immune system by acting on the gut-body network when administered at pharmacologically active doses. The process development and formulation capabilities of our platform develop selected microbes into clinical product candidates. Our development of monoclonal microbials has the potential to be more efficient than those of other therapeutic classes such as cell therapy, monoclonal antibodies and small molecules, because we believe monoclonal microbials do not require the lengthy target validation and compound discovery requirements of conventional drug discovery. The efficiency of our platform has, in a relatively short period of time, allowed us to produce three product candidates for a range of inflammatory diseases and cancer.