Ablynx announced that it has selected a new GPCR targeting development candidate, ALX-0651, an anti-CXCR4 Nanobody which is being developed for hematopoietic stem cell mobilisation

GHENT, Belgium | February 11, 2010 | Ablynx [Euronext Brussels: ABLX] announced today that it has selected a new GPCR targeting development candidate, ALX-0651, an anti-CXCR4 Nanobody which is being developed for hematopoietic stem cell mobilisation. The Company is also releasing new data on pulmonary to systemic administration and needle-free administration of Nanobodies. Ablynx will present an update of its therapeutic pipeline and its recent technology advances at its R&D Investor Update in New York, USA tomorrow at 8.00 a.m. EST.

Selection of GPCR targeting development candidate

In January 2009, Ablynx successfully generated functional Nanobodies against CXCR4, a clinically validated GPCR. Today, the Company has announced that its criteria for preclinical development have been reached and that Ablynx will progress this compound named ALX-0651, towards the clinic. CXCR4 plays an important role in cell movement, tumor growth and metastasis.

New data on alternative route of delivery and R&D update

Ablynx has announced additional data on the use of a needle-free device for transdermal delivery and data on the administration of Nanobodies systemically via the pulmonary route.

Specifically, the Company has successfully demonstrated that Nanobodies can be made as a solid formulation in clinically relevant amounts. Furthermore, when administered via a needle-free route, they have shown a similar pharmacokinetic (PK) profile compared with subcutaneously injected Nanobodies.

In addition to previous data showing that Nanobodies can be detected in the systemic circulation following delivery to the lungs, Ablynx has now demonstrated dose-dependent systemic bioavailability and functionality for Nanobodies delivered via the intrapulmonary route. The data indicate that they can survive the lung environment and can then be detected systemically with intact biological activity. Ablynx continues to investigate new routes of administration including oral to systemic, ocular and other forms of transdermal delivery.

"In the last twelve months we have made significant progress in advancing both our therapeutic pipeline and Nanobody-based technology platform,” commented Dr Edwin Moses, CEO and Chairman of Ablynx. "Nanobodies have clearly demonstrated themselves as a very promising new class of therapeutics and we are focused on developing our clinical pipeline as well as our technology platform. With these new data and new development candidate, we have again illustrated the advantages of Nanobodies over alternative approaches such as classical antibodies and small molecules," added Dr Moses.

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 230 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007.

Ablynx is developing a portfolio of Nanobody-based therapeutics in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Ablynx now has over 25 programmes in its therapeutic pipeline including four Nanobodies in clinical development. So far, Nanobodies have been successfully generated against more than 190 different protein targets including several complex targets such as chemokines, GPCRs, ion channels and viruses, which are typically very difficult to approach with conventional monoclonal antibodies. Efficacy data have been obtained in 28 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 130 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 Pfizer (previously 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 entered a Phase II study in patients undergoing percutaneous coronary intervention (PCI) in September 2009. Ablynx demonstrated proof-of-concept by biomarker for ALX-0081 in December 2009. ALX-0681 subcutaneous administration of the anti-von Willebrand factor (vWF) Nanobody has concluded Phase I.

In December 2009, Ablynx initiated a double-blind, randomised, placebo-controlled Phase I study with ALX-0141, a Nanobody targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL), in healthy postmenopausal women. ALX-0061, an anti-IL6R Nanobody is in preclinical development for the treatment of autoimmune and inflammatory diseases. In addition, in September 2009, Ablynx’s partner Pfizer entered a Phase II study in RA patients, with an anti-TNF-alpha Nanobody.

SOURCE: Ablynx