Ablynx announced that it has advanced ALX-0061, a new Nanobody®-based therapeutic programme, into preclinical development for the treatment of autoimmune and inflammatory diseases

GHENT, Belgium | June 29, 2009 | Ablynx [Euronext Brussels: ABLX], a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins, today announced that it has advanced ALX-0061, a new Nanobody®-based therapeutic programme, into preclinical development for the treatment of autoimmune and inflammatory diseases.

ALX-0061 is a selective, low molecular weight biologic, binding to the IL6 receptor (IL6R). It has a very high potency and demonstrated a favourable PD, PK and safety profile in preclinical testing compared with the benchmark molecule. ALX-0061 has no Fc-mediated effector function which may translate into an improved safety profile. It also avoids cross-linking IL6R due to its monovalent binding to the target.

The low molecular weight and desirable biophysical properties of this Nanobody® open up opportunities for alternative routes of administration and superior tissue penetration in the clinical setting. The Nanobody® can be manufactured at a relatively low cost in a microbial system.

"We are delighted to strengthen our product portfolio by advancing another novel Nanobody®, discovered using our proprietary Nanobody® platform, into preclinical development. It is well positioned to translate into a superior treatment for rheumatoid arthritis and other autoimmune diseases. There are already three Nanobodies® in clinical development, with our lead programme, ALX-0081, a novel anti-thrombotic, on track to start Phase II in the next few months”, commented Dr. Edwin Moses, Chief Executive Officer and Chairman of Ablynx.

About ALX-0061 (IL6R)

ALX-0061 is a Nanobody® binding to the interleukin-6 receptor (IL6R). It has the potential to differentiate through its high potency, high stability and low molecule weight of only 26kD which should translate into superior tissue penetration, attractive PK/PD and superior safety and efficacy profile compared with a benchmark monoclonal antibody.

The involvement of the IL6 pathway in a variety of diseases indicates that multiple indications can be pursued with large market potential including rheumatoid arthritis (RA), Crohn’s disease, Castleman’s disease, multiple myeloma and systemic lupus erythematosus (SLE). Although there are biologics on the market for treatment of RA, there is a clear unmet medical need for novel RA treatments as many patients are not sufficiently helped with the current disease-modifying therapies such as TNF-α therapies and methotrexate.

About Ablynx [Euronext Brussels: ABLX] - http://www.ablynx.com

Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company currently has over 210 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007.

Ablynx is developing a portfolio of Nanobody®-based therapeutic programmes in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Nanobodies® have been generated against more than 150 different disease targets. Importantly the Nanobodies® which naturally exist in llamas have a very high homology with humans. Efficacy data has been obtained in over 26 in vivo models for Nanobodies® against a range of different targets.

Ablynx has an extensive patent position in the field of Nanobodies® for healthcare applications. It has exclusive and worldwide rights to more than 50 families of granted patents and pending patent applications, including the Hamers patents covering the basic structure, composition, preparation and uses of Nanobodies®.

Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Wyeth Pharmaceuticals. Ablynx is building a diverse and broad portfolio of therapeutic Nanobodies® through these collaborations as well as through its own internal discovery programmes. The Company’s lead programme, ALX-0081, an intravenously administered novel anti-thrombotic has reached its primary endpoint in a multi-dose Phase Ib study in patients undergoing PCI and is on track to initiate Phase II during the third quarter of 2009. ALX-0681, also an anti-thrombotic but with a subcutaneous route of administration is currently in Phase I in healthy volunteers. Ablynx has progressed ALX-0141, an anti-RANKL Nanobody® for bone disorders into preclinical development and aims to initiate a Phase I study before the end of 2009. In addition, Ablynx’s partner Wyeth Pharmaceuticals is currently in Phase I study with an anti-TNF-alpha Nanobody®.

SOURCE: Ablynx NV.

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