The Apitope® Discovery Platform

Apitope has established a robust discovery platform for identifying tolerogenic (i.e. tolerance-inducing) peptides, which Apitope has used to develop an innovative pipeline of disease-specific product candidates focused on significant unmet medical need. Apitope's patented discovery platform enables a cost-efficient selection of peptides, which are likely to be safe and well tolerated.

Identifying the self-antigen towards which autoimmune reactions are targeted is a first step in assessing whether antigen-specific immunotherapy can be used. Once the molecular target has been discovered, the platform can design tolerogenic soluble peptides that induce disease halting, selective T-cell tolerance to the target self-antigen.

Apitope's in vitro screening method first identifies peptides that do not require processing by APCs but are capable of binding to the major histocompatibility complex class II ("MHC II") molecules on the surface of tolerogenic APCs in the appropriate conformation. This patented method significantly reduces the number of possible T-cell epitopes that require evaluation during expensive in vivo tests.

In the following phases of the process, human T-cell reagents are generated, which are used to identify T-cell epitopes and are an important component in the design of apitopes®. The human T-cell reagents are specific for naturally processed antigens. Apitopes® are selected to have the potential to stimulate these T cells when presented to them by APCs expressing co-stimulatory signals.

Subsequent in vivo data on the newly discovered apitopes® assesses the capacity of the apitopes® to induce tolerance to the antigen from which they were developed. Eventually, these apitopes® are intended to induce an antigen-specific Treg cell response when administered in soluble form to a human carrying the appropriate MHC II receptor.

When an apitope® has been characterized by both in vitro and in vivo assays and has passed Apitope's selection criteria at each stage, it is designated as a product candidate and moved into the pre-clinical development phase.