Ablynx received a $3 million milestone payment from Pfizer on initiation by the latter of a Phase I trial with a second Nanobody candidate (PF-05230905) targeting tumor necrosis factor alpha (TNF-alpha). The study is anticipated to be completed by the second quarter of 2011. Pfizer’s lead anti-TNF-alpha Nanobody ATN-103, is currently undergoing Phase II evaluation in patients with rheumatoid arthritis.
Ablynx originally signed its anti-TNF-alpha nanobody alliance with Wyeth in 2006. The subsequent acquisition of Wyeth by Pfizer in 2009 means Pfizer now owns exclusive worldwide development and commercialization rights to the program.
Ablynx is dedicated to the discovery and development of its Nanobody class of therapeutic proteins based on camelid-derived single domain antibody fragments.
The firm currently has a number of Nanobody candidates in clinical trials, either in house or through partnerships. Lead program ALX-0081 is an intravenously administered antithrombotic targeting von Willebrand Factor (vWF), which started in a Phase II study in patients undergoing percutaneous coronary intervention in September 2009. The firm is separately developing a subcutaneous version of the candidate, ALX-0681, and in September started a Phase II study evaluating a combination of both ALX-0081 and ALX-0681 in the treatment of patients with acquired thrombotic thrombocytopenic purpura (TTP).
In December 2009 Ablynx initiated a double-blind, randomized, placebo-controlled Phase I study with ALX-0141, a Nanobody targeting receptor activator of nuclear factor kappa B ligand (RANKL), in healthy post-menopausal women. Positive initial data from this trial was reported in September 2010. Meanwhile, the preclinical-stage anti-IL6R Nanobody ALX-0061 is expected to start in Phase I/II studies in patients with active rheumatoid arthritis, during the first quarter of 2011.
In addition to its clinical-stage partnership with Pfizer, Ablynx also has ongoing collaborations with Boehringer Ingelheim (BI), Merck Serono, and Novartis, which are in preclinical development. Two separate collaborations with BI are centered on the development of Nanobodies against a specific Alzheimer disease targets, and up to 10 other candidates across multiple therapeutic areas. The agreement with Merck Serono is centered on developing Nanobodies against two targets in immunology and oncology. Ablynx’ agreement with Novartis covers Nanobodies against targets in a range of disease areas, including targets that are difficult to address using conventional antibodies or their fragments.