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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. With several ActoBiotics™ in various stages of clinical and preclinical development, ActoGeniX’s initial focus is on areas with unmet need in gastrointestinal, immunological and metabolic diseases.
TopAct™ is a proprietary platform technology which makes it possible to genetically engineer non-pathogenic bacteria so they become effective vehicles for the delivery of therapeutic proteins and peptides into the GI tract. ActoGeniX has chosen the food bacterium Lactococcus lactis as the preferred microorganism for the application of TopAct™. Lactococcus lactis has been used for thousands of years in preparation of food products such as yoghurt and cheese and is widely recognized as completely safe for human consumption.
Current collection of more than 1600 different ActoBiotics™. Expression of the following has been performed:
TopAct allows a very efficient drug development: from idea to IND takes 15 months.
AG013 is an ActoBiotic™ delivering Trefoil Factor peptide (TFF) for the treatment of oral mucositis. ActoGeniX completed in the US a Phase 1b, multi-center, single blinded, placebo-controlled, sequential dose escalation study to assess the safety of topically applied AG013 in 21 subjects receiving induction chemotherapy for the treatment of cancers of the head and neck. AG013 was proven safe and well tolerated. Analysis of initial efficacy showed a 35% reduction of the percentage of days with ulcerative oral mucositis in the AG013-treated patients versus the placebo-treated patients. Furthermore, close to 30% of patients treated with AG013 were full responders while all placebo-treated patients developed ulcerative oral mucositis. Orphan Drug status has been obtained in EU, pending in US.
AG014 is based on the expression and local delivery of an anti-TNF-alpha antibody fragment. AG014 provides the advantage of a proven therapeutic approach in IBD without any of the systemic side effects as there is only localized (sub)mucosal presence of the anti-TNF-alpha moiety without systemic exposure. Preclinical safety and pharmacodynamic studies have shown that AG014 is safe and efficacious in validated models of colitis. The IND application will be filed in the first quarter of 2014, and the phase 2A study in ulcerative colitis patients is scheduled to start in the second half of 2014.
The generation of ActoGeniX’ preclinical product pipeline is based on 3 lines of research. First, protein therapeutics targeting local mucosal, submucosal and luminal targets in the gut. Secondly, antigen/allergen-derived peptides targeting the immune system in the gut and inducing a state of tolerance towards these antigens and allergens. And thirdly, targeted modulation of the microbiome by antibody- or peptide-toxin conjugates.
ActoGeniX is progressing its preclinical product pipeline through preclinical development towards IND-ready stage. Positive efficacy data have been obtained in animal models for several disease areas. These areas include:
Notably, ActoGeniX has recently obtained efficacy data on the effect of an ActoBiotic™ expressing the anti-inflammatory cytokine IL-10 combined with the auto-antigens pro-insulin or GAD-65 in a type 1 diabetes animal model. This groundbreaking work has been performed in collaboration with Professor Chantal Mathieu at the University of Leuven with the support of an European FP7-program (Naimit) and a grant from the Juvenile Diabetes Research Foundation (JDRF). These data have been published in the top tier Journal of Clinical Investigation.
Based on the same principle, ActoGeniX is developing oral products for the treatment of allergic diseases (asthma amongst others) as part of the research agreement with Stallergenes.
ActoGeniX has also initiated testing of this concept for its effect in a celiac disease model.
Recently, ActoGeniX started a new line of research and product development in the arena of targeted modulation of the microbiome.
ActoGeniX closed 2 major partnership. In November 2012, ActoGeniX entered into a research collaboration with Merck. Last year, ActoGeniX signed an agreement with Stallergenes to develop together an innovative new class of oral treatments for allergy.