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October Edition 2020

Apitope – World-leading clinical-stage biotech firm, developing antigen-specific immunotherapeutics for autoimmune diseases


Nearly a century has passed since the first report describing antigen-specific immunotherapy (antigen-SIT) was published. Research into the use of antigen-SIT in the treatment of both allergic and autoimmune diseases has increased dramatically. Autoimmune and allergic diseases are significant causes of morbidity. Antigen-based immunotherapy (AIT) is immunologically the most satisfying means of explicitly targeting only those T cells driving disease, thereby inducing antigen-specific immune tolerance, with the lowest adverse risk profile. AIT is highly effective in rodent models of T cell-driven inflammation and is now in clinical trials. One of the major goals for autoimmune disease therapies is to restrict the immunosuppressive elements of the treatment so that they act upon the relevant autoimmune response without engendering a state of generalized immunosuppression.

Apitope is a clinical-stage biotech company developing potential first-in-class antigen-specific immunotherapeutics targeting the immunological basis of autoimmune diseases. The firm uses its novel, proprietary discovery platform to select and develop highly specific peptide-based therapies, known as "apitopes®," which restore the immune system's natural balance (immune tolerance). This action mechanism avoids global immune suppression and has the broad potential to treat a wide variety of autoimmune diseases. Besides, Apitope has developed a robust pipeline with several innovative, potential first-in-class product candidates advancing towards clinical development to treat, amongst other indications, uveitis, factor VIII inhibitors, myocarditis, and rheumatoid arthritis.

Path-breaking technologies

Apitopes®: Apitope develops potential first-in-class antigen-specific immunotherapies targeting the immunological basis of autoimmune diseases. Apitopes® treat autoimmune diseases (and treat and prevent other undesired immune responses) at the earliest possible moment in the inflammatory immune response to prevent further damage to the body. They are designed to mimic naturally processed epitopes to restore the immune system's natural balance (i.e., tolerance to a self-antigen). While current therapies for autoimmune diseases typically affect the immune system and modulate only the malfunctioning part of the immune system to avoid such global immune suppression. They can be selected for the treatment of any autoimmune or allergic disorder and other undesired immune responses (anti-drug antibodies) against biologic (protein) therapeutics. It can select and develop apitopes® using its patented and cost-efficient discovery platform that enables the continuous selection of peptides that are likely to be safe and well-tolerated.

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. Apitope's in vitro screening method first identifies peptides that do not require processing by APCs but can bind 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. 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. 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.

The ardent visionary behind the triumph of Apitope

Hayley French, Ph.D., MSc (IP), CLP serves as the Chief Executive Officer of Apitope. Dr. French brings over twenty years' experience of negotiating licenses and collaborations and managing alliances in the life sciences sector. Before joining Apitope, Dr. French spent three years at Novartis, based at the Basel headquarters, where she worked closely on all global deals and collaborations in the respiratory division. Dr. French started her career at University College London Ventures, where she was responsible for developing, managing, and commercializing technologies in the life sciences sector. She is past president of the Licensing Executives Society Britain & Ireland, and chair of the Licensing Executives Society International (LESI) life sciences committee.

Dr. French also teaches on the LESI Intellectual Asset Management courses and is a regular speaker on IP licensing and negotiation. She has a B.Sc. in Microbiology from the University of Liverpool and a Ph.D. in Microbiology and an M.Sc. in intellectual property from the University of London and is a certified licensing professional (CLP).

"We use our novel, proprietary discovery platform to develop highly specific peptide-based therapies, apitopes® which restore the natural balance of the immune system."