Ablynx Awarded €1.5M to Advance Nanobody Development

€1.1 million will be used on preclinical RSV candidate and €0.4 million to study delivery into the CNS.

Ablynx received a grant worth €1.1 million (about $1.38 million) from the Flemish agency for Innovation by Science and Technology (IWT) and a second unrelated grant of €0.4 million (roughly $0.5 million) from the Portuguese government as part of a consortium. Ablynx is focused on the discovery and development of Nanobodies, a novel class of therapeutic proteins based on single-domain antibody fragments.

The IWT grant allows Ablynx to accelerate preclinical development, which began in March, of ALX-0171 for respiratory syncytial virus (RSV) infections. The Nanobody reportedly binds to RSV and neutralizes the virus. In vivo data has demonstrated its potential to be effective both in the prevention of infection as well as in treatment once infection has occurred, according to Ablynx.

ALX-0171 is Ablynx’ first preclinical Nanobody candidate to be delivered through a route other than injection; ALX-0171’s stability makes it suitable for inhalation. It can also be manufactured at relatively low cost in microbial systems, Ablynx adds.

The grant from the Portuguese government will allow Ablynx and its collaborators to explore routes of delivery for Nanobodies into the central nervous system (CNS) and to develop Nanobodies against therapeutically relevant CNS targets.

Nanobodies reportedly contain the unique structural and functional properties of naturally occurring heavy-chain antibodies. The technology was originally developed following the discovery that camelidae possess fully functional antibodies that lack light chains. These heavy-chain antibodies contain a single variable domain (VHH) and two constant domains (CH₂ and CH₃). Importantly, the cloned and isolated VHH domain is a perfectly stable polypeptide harboring the full antigen-binding capacity of the original heavy-chain antibody, Ablynx points out.

Founded in 2001 in Ghent, Belgium, Ablynx now has over 25 programs in its pipeline, including four Nanobodies in clinical development. So far, Nanobodies have been successfully generated against more than 190 different protein targets including chemokines, GPCRs, ion channels, and viruses, according to the company. Efficacy data has reportedly been obtained in 28 in vivo models for Nanobodies against a range of different targets. Ablynx has collaborations with several companies including Boehringer Ingelheim, Merck Serono, Novartis, and Pfizer.

The firm’s lead program, ALX-0081, is an intravenously administered antithrombotic. In September 2009, it entered a Phase II study in patients undergoing percutaneous coronary intervention. In the same month, the firm’s partner Pfizer moved an anti-TNF-alpha Nanobody into a Phase II trial in rheumatoid arthritis patients. And 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 in healthy postmenopausal women. Additionally, ALX-0681, a subcutaneous administration of the anti-von Willebrand factor, recently concluded a Phase I trial, says Ablynx.

At the preclinical stage, ALX-0061, an anti-IL6R Nanobody, is being developed for the treatment of autoimmune and inflammatory diseases. In February, Ablynx also confirmed further development of another preclinical candidate, ALX-0651, a Nanobody against CXCR4, which plays an important role in cell mobility, tumor growth, and metastasis.