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The University of Leuven and ActoGeniX, a clinical stage biopharmaceutical company focused on the development and commercialization of ActoBiotics™, today announce the results of a study in a mouse model of Type 1 diabetes evaluating the effect of an ActoBioticTM. ActoBiotics™ represent a novel class of orally administered and locally acting biopharmaceuticals. The results of the study have been published in the authoritative Journal of Clinical Investigation.
Prof. Chantal Mathieu and her team at the University Hospital of Leuven, Belgium, have realized a major breakthrough in the treatment of Type 1 diabetes in an animal model of autoimmune diabetes. Using an orally administered ActoBioticTM which secretes both the auto-antigen pro-insulin and the immune-modulatory cytokine interleukin-10 (IL-10), the team was able to revert established diabetes in a mouse model of spontaneous Type 1 diabetes. This innovative and effective strategy was without side effects and can now be further developed for human application.
Dr. Chantal Mathieu and her team describe in the Journal of Clinical Investigation that the orally administered ActoBioticTM, modified to secrete concurrently the beta-specific antigen pro-insulin and a biologically active immune-modulatory cytokine interleukin-10, can stably reinstate normal serum glucose levels in newly diagnosed diabetic NOD mice (non-obese diabetic mice). Fundamentally, the data showed that this effect is driven by a profound resetting of the immune system towards a safe and long-lasting beta-cell specific tolerance. Find more information in the full article: http://www.jci.org/articles/view/60530
In the context of current human clinical trials in Type 1 diabetes, this is a valuable and significant contribution to the concept that efficacy and safety of combination therapeutics can be addressed in a rational experimental approach.
This study demonstrates that oral intake of ActoBioticsTM capable of delivering auto-antigens and immune-modulating molecules to the gut mucosa provide a novel and safe strategy to control autoimmune diabetes via long-lasting restoration of antigen-specific tolerance.
This study has been realized with the support of the European Community's Health Seventh Framework Programme (NAIMIT), the Juvenile Diabetes Research Foundation (JDRF), and the Agency for Innovation by Science and Technology in Flanders (IWT).
The incidence of Type 1 diabetes in childhood is increasing at about 3% per year. Type 1 diabetes is the most common metabolic disease in the young. About two million people (around 0.5 % of the population) in Europe and several million people world-wide suffer from this disease.
Type 1 diabetes is an autoimmune disease characterised by immune-mediated destruction of insulin-producing beta-cells in the pancreas. The incidence of Type 1 diabetes in childhood is increasing at about 3% per year. Type 1 diabetes is the most common metabolic disease in the young. About two million people (around 0.5 % of the population) in Europe and several million people world-wide suffer from this disease. At present, Type 1 diabetes cannot be prevented or arrested in its course and lifelong insulin therapy is needed for survival. Still, chronic complications, such as eye disease, kidney disease and vascular disease, affect life span and in particular quality of life. Since it carries such a significant chronic disease burden, Type 1 diabetes has become a major public health concern worldwide, emphasizing the urgent need for safe and effective intervention and prevention strategies. The true cause of Type 1 diabetes remains elusive, but an autoimmune destruction of the insulin-producing beta-cell in the pancreas lies at the basis. Finding ways to interfere with this immune system, aimed at restoring tolerance in a specific way towards the beta-cell without interfering with the immune defences of the subject opens the way for prevention of this disease. To date, several interventions have been assessed in patients with Type 1 diabetes and treatment with antibodies directed against a marker of T lymphocytes, anti-CD3, have been the most promising. However, till now, solid evidence on the applicability of this intervention in a safe and acceptable way in patients is lacking.
ActoGeniX is a biopharmaceutical company focused on the development and commercialization of ActoBiotics™, a novel class of orally available biopharmaceuticals for the targeted treatment of severe diseases with a high medical need. ActoBiotics™ represent a novel concept for oral administration of therapeutic proteins, and are designed to be safer and more effective than injectable biopharmaceuticals. ActoBiotics™ can deliver a wide range of therapeutic peptides and proteins, including cytokines, enzymes, hormones and monoclonal antibodies.
AG013, ActoGeniX´s lead product for the treatment of oral mucositis in cancer patients has been evaluated in a phase 1B clinical trial in the US, confirming safety and tolerability as well as initial efficacy. Moreover, in preclinical models, ActoGeniX has confirmed the broad applicability of ActoBiotics™ and its proprietary technology platform for a wide range of diseases, including gastrointestinal, metabolic, immune diseases and allergies.
ActoGeniX was founded in 2006 as a spin-off from VIB and Ghent University. The Company is headquartered in Ghent (Belgium) and employs approximately 20 employees, half of whom are PhD’s, MD’s, or PharmD’s. ActoGeniX raised 35.5 million Euro (approximately 50 million US$) in two equity financing rounds from a consortium of leading life sciences investors such as Gimv, Biotech Fund Flanders, Baekeland Fund, Biovest (Belgium), Life Sciences Partners, Aescap Venture (The Netherlands) and Ventech (France).
ActoGeniX has a strong and broad intellectual property position with a patent estate encompassing more than 20 distinct patent families. With broad patent claims already granted in major territories like the US and Europe, ActoGeniX is uniquely positioned to successfully exploit the commercial potential of its promising ActoBiotics™.
The group at the University of Leuven has been involved in studies on prevention and intervention in Type 1 diabetes, extending from bench to bedside. Prof. C. Mathieu leads a basic science laboratory specialised in in vitro studies and animal models of Type 1 diabetes, and is head of the clinical Endocrinology department, where over 1000 patients with Type 1 diabetes are being treated. In that clinical department, several clinical studies on diabetes therapies are currently taking place.
The laboratory is part of several research networks, funded by national and international agencies, amongst which the JDRF (Juvenile Diabetes Research Foundation), FWO (Fonds Wetenschappelijk Onderzoek Vlaanderen), and the European Commission. The latter supports a network on Immune Intervention in Type 1 diabetes (NAIMIT), in the context of Framework 7.