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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 that makes 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:
Creation of new ActoBiotics™ for PoC in animal models is straightforward and takes between four to six weeks.
TopAct allows a very efficient drug development: manufacturing, clinical formulation, preclincal pharmacoloy and toxicology studies can be performed in 1 year time frame.
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.
A phase IIb shall start in 2013, which will be a multicenter trial in the US and Europe.
AG014 is an ActoBiotic™ delivering an anti-TNF antibody for the treatment of Inflammatory Bowel Disease (Crohn's Disease & Ulcerative Colitis). This product is currently in pre-clinical development and anticipated to enter into the clinic in 2013.
ActoGeniX is developing an ActoBiotic™ expressing and secreting the anti-inflammatory cytokine IL-27 for the treatment of inflammatory bowel disease, celiac disease, and other auto-immune disorders. Positive efficacy data have been obtained with this product in an animal model of colitis. This work has been performed in collaboration with Professor Scott Durum at the National Cancer Institute (Frederick MD, US). This product is currently in pre-clinical development and anticipated to enter into the clinic in 2013.
ActoBiotics™ Type 1 Diabetes
ActoBiotic™ delivering beta-cell specific antigens and IL-10 in combination with anti-CD3. The company has showed an excellent long term remission of NOD diabetic mice via an antigen specific induction of immune tolerance against beta-cell antigens. For this program, an active partnering process has been initiated, in order to progress the ActoBiotic™ towards entering into the clinic.
ActoBiotics™ Celiac Disease
ActoBiotic™ delivering antigenic gliadin epitopes in order to obtain oral tolerance. A proof of concept has been obtained in sensitized non-obese diabetic abdegrees Dq8 transgenic mice by oral administration of a DQ8-restricted gliadin peptide. ActoGeniX is looking for a partner to initiate clinical studies in Celiac Disease patients.
Actogenix is seeking co-development and marketing partners for its (pre) clinical products. The company is also interested in collaboration deals with companies who wish to combine the TopAct™ oral delivery system with proprietary therapeutic proteins or peptides.
Phone: +32 9 261 06 00
Fax: +32 9 261 06 19
Foundation date: 6/2006