The TregTherapeutics tolerogenic approach has been developed over the past two decades, primarily using various models of experimental autoimmune encephalopathy (EAE) in laboratory animals.
These models are typical of investigational research centered on multiple sclerosis. The TregTherapeutics approach was developed as a possible application for MS, and its treatment and cure remain a core objective for the company. Despite this fact, it has been discovered that the underlying principles governing the induction of tolerance are equally applicable to a wide range of disease states that have chronic inflammation as a common denominator.
One key scientific objective underlying the approach for an MS therapy was to discover a way to create a strong, sustained tolerogenic immune response in laboratory animals. The step-by-step research design and subsequent discoveries that proceeded from that objective have been significant – a key way to modify conventional fusion proteins to achieve the benefits of linkage but without covalent bonding, a way to link numerous proteins without the complexity of conventional restrictions, a way to convert a tolerogenic cytokine into a super-tolerogenic agent without functionally modifying its structure. The mechanism of action of this approach is such that it is efficacious, even when the pathogenic antigen is unknown and/or not included in the formulation. Its ability to take advantage of a prolonged, super-tolerogenic, localized approach sets the stage perfectly for endogenous antigen-induced and Treg executed, down-regulation.
The broader implications of these discoveries are profound, with potential application to dozens of autoimmune diseases, as well as, potential application to neurodegenerative protein aggregation disorders. This latter condition leads to the intransigent diseases like Alzheimer’s, Parkinson’s, and Amyotrophic Lateral Sclerosis (ALS).