Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has approximately 30 programmes in the pipeline and seven Nanobodies in clinical development.
Potent functional Nanobodies have been generated to therapeutically relevant targets of all major classes, including cytokines, enzymes, cell surface receptors such as receptor tyrosine kinases and GPCRs, as well as ion channels.
ALX-0061 is a Nanobody that binds IL-6 receptor. It reported excellent safety and efficacy Phase IIa results at week 24 in February 2013. Ablynx signed a global license agreement with AbbVie in September 2013 and will responsible for completing Phase II development of ALX-0061 in RA and SLE. Upon achievement of pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 after which they will responsible for Phase III clinical development, registration and worldwide commercialisation.
Caplacizumab is a Nanobody targeting von Willebrand factor (vWF) and is being evaluated in patients with the orphan disease acquired thrombotic thrombocytopenic purpura (TTP). It is currently in a worldwide potential pivotal Phase II study and could be the first Nanobody on the market.
Ozoralizumab, an anti-TNF-alpha Nanobody achieved positive clinical proof-of-concept in a Phase II study in patients with active rheumatoid arthritis in May 2011. Ablynx is currently looking for a partner to license this product.
Ablynx’s anti-RANKL programme to treat bone-related disorders, ALX-0141, has completed a Phase I study. In October 2013, Ablynx exclusively licensed the product to Eddingpharm for development and commercialisation in Greater China.
Ablynx’s first inhaled Nanobody, ALX-0171,has the potential to be a first-in-class therapeutic to treat respiratory syncytial viral infections (RSV). Positive safety results were published in September 2012 and additional safety and pre-clinical studies will be performed throughout 2013. The first-in-infant study is expected to start in 2014.
In parallel with its internally developed products, Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including AbbVie, Boehringer Ingelheim, Eddingpharm, Merck Serono, Merck & Co and Novartis. Ablynx is building a diverse and broad portfolio of therapeutic Nanobodies through these collaborations. The first partnered programme, ALX-0761, with Merck Serono entered clinical development in 2013 and is being developed to treat inflammatory diseases.
Ablynx has a strong and broad patent portfolio of 550 patent applications and granted patents covering various aspects of the discovery, generation, optimalisation, formatting, manufacture, administration, formulation and clinical use of Nanobodies, as well as covering its clinical development programmes and product candidates. This, combined with the extensive experience and expertise that Ablynx has established as the first company to discover and develop Nanobodies and to achieve clinical proof-of-concept for multiple clinical programmes, puts Ablynx in a unique position to exploit the Nanobody platform in the field of therapy and diagnosis.
Ablynx is also the holder worldwide of the trademarks Ablynx®, Nanobody® and Nanoclone®.