Three mid-stage trials are ongoing with camelid-derived antibody fragment candidates.

Ablynx received a €3 million (about $4 million) milestone payment from Boehringer Ingelheim (BI) as part of the firms’ ongoing alliance for the development and commercialization of up to 10 Nanobody® candidates in multiple therapeutic areas. Ablynx says it has now received €12 million in milestones through the collaboration, and could receive up to €125 million for each Nanobody therapeutic developed, plus additional royalties. BI retains responsibility for the development, manufacture and commercialization of products resulting from the partnership. Ablynx has certain co-promotion rights in Europe.

The latest news comes just 24 hours after Ablynx reported starting the first clinical trial with its lead in house Nanobody candidates targeting anti-von Willebrand factor, in patients with acquired thrombotic thrombocytopenic purpura (TTP). The trial will assess administration of both the intravenous and subcutaneous formulations of the Nanobody treatment as an adjunct to standard plasma exchange therapy. “We believe that our anti-vWF Nanobody may reduce the number of days a TTP patient is hospitalised for plasma exchange thereby reducing the overall number of plasma transfusions and increasing the quality of life for these patients,” commented Edwin Moses, Ph.D., CEO and Chairman of Ablynx.

Nanobodies  are antibody-based therapeutic proteins, generated in camelids, which comprise the structural and functional properties of naturally-occurring heavy-chain antibodies. Ablynx claims the molecules have a high homology with the VH domains of human antibodies, can be further humanized without any loss of activity, and have low immunogenic potential. Nanobodies thus display the beneficial features of both antibodies and small molecule drugs, the firm continues. They demonstrate high target specificity and affinity, are also extremely stable and easy to manufature, and could potentially be administered by means other than injection.

Ablynx’s lead clinical programme ALX-0081, is an intravenously administered anti-thrombotic candidate that targets von Willebrand factor, and is currently also undergoing Phase II trials in patients undergoing percutaneous coronary intervention (PCI). The firm is separately developing a subcutaneously administered version of the Nanobody, ALX-0681. Both ALX-0081 and ALX-0681 will be administered in the Phase III TTP trial started yesterday.

Ablynx’ third in house clinical program, ALX-0141, is a humanized Nanobody that targets the receptor activator for nuclear factor kappa B ligand (RANKL), which is a key regulator of bone metabolism. Ablynx aims to develop ALX-0141 for a range of indications including the treatment of osteoporosis. In September the firm reported positive results from a Phase I safety and pharmacokinetic study with ALX-0141 in healthy postmenopausal women.

Ablynx has a number of ongoing Nanobody development collaborations ongoing with partners including Boehringer Ingelheim, Merck Serono, Novartis and Pfizer. A Phase II trial with the Pfizer-partnered TNF-alpha Nanobody ATF-103, was initiated in September 2009.

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