History

The TopAct™ technology platform was discovered in 1994 by scientists at the University of Ghent under the leadership of Dr Lothar Steidler, and provides an elegant solution for the delivery of therapeutic proteins and peptides via oral administration instead of injection.

Dr Steidler and his colleagues, later at the Flanders Institute of Biotechnology (VIB), further developed and improved TopAct™, turning it into a versatile and broadly applicable platform that enables the engineering of food-grade bacteria to become efficient production and delivery units for therapeutic proteins and peptides. Subsequently, a team of scientists led by Dr Pieter Rottiers provided in vivo proof-of-concept for the therapeutic effect of these engineered bacteria. A new concept was born: ActoBiotics™.

In June 2006, ActoGeniX was founded as a spin-off from VIB and the University of Ghent, to commercially develop ActoBiotics™. At that stage, VIB contributed their entire patent portfolio, ongoing programs and existing know-how exclusively to ActoGeniX.

In January 2007, ActoGeniX closed a Series A funding round of €20 million, one of the largest among European biotech start-ups, from a syndicate of experienced life science investors including GIMV, Biotech Fund Flanders and Baekeland Fund (Belgium), Life Sciences Partners and Aescap (The Netherlands) and Ventech (France).

In July 2007, ActoGeniX announced the approval of a €3 million grant from the Institute for Promotion of Innovation by Science and Technology in Flanders (IWT), to support its innovative therapeutic drug development activities during a two-year period.

In the first quarter of 2009, ActoGeniX announced that it had raised an additional €15.5 million from a strong syndicate of life science investors, including new investor Biovest (Belgium) as well as the existing investors.

In the second quarter of 2009, ActoGeniX was awarded a €0.9 million grant by IWT, to support the clinical development of AG013, a novel ActoBiotic™ for the treatment of oral mucositis in cancer patients.

Today, ActoGeniX holds a broad portfolio of ActoBiotics™ for the treatment of several gastrointestinal, immunological and metabolic diseases.

AG013, the Company’s lead product, is currently being developed for the treatment of oral mucositis. In May 2009, the FDA approved ActoGeniX’s IND application, allowing the Company to initiate a phase 1B clinical trial with AG013 in cancer patients at risk of developing oral mucositis. Meanwhile, ActoGeniX has started this clinical study in collaboration with several reputed oncology centers in the US. The primary aim of the study is to evaluate safety and tolerability of AG013, but it will also allow collection of initial efficacy data.

AG011, ActoGeniX’s first product for the treatment of inflammatory bowel disease (IBD) was evaluated in a phase 2 clinical trial in ulcerative colitis patients. All primary endpoints were successfully met. Based on the outcome of the clinical study, ActoGeniX is further developing  an optimized formulation of Actobiotics secreting anti-TNFalpha monoclonal antibodies for the treatment of inflammatory bowel disease.