Boehringer Ingelheim selected a Nanobody lead candidate under its partnership with Ablynx related to the development of Alzheimer disease treatments. This is the first lead candidate emerging from the collaboration and will result in a €2 million (about $2.47 million) milestone payment to Ablynx.
In January 2007, Boehringer Ingelheim and Ablynx entered into a worldwide research and licensing agreement to discover and develop new therapies for Alzheimer disease using Ablynx' Nanobodies. The arrangement calls for up to $265 million in milestone fees plus undisclosed royalties. Boehringer Ingelheim is solely responsible for the development, manufacture, and commercialization of any resulting products.
“Ablynx’ delivery of this potentially first-in-class Nanobody candidate for the treatment of Alzheimer disease highlights the speed at which we progressed from initiation of the discovery program in 2007 to this stage of development for a very challenging target,” notes Edwin Moses, Ph.D., CEO and chairman of Ablynx. “This lead candidate demonstrates the power of the Nanobody platform in addressing a complex disease such as Alzheimer.”
Ablynx says that its Nanobodies combine the advantages of conventional antibodies with important features of small molecule drugs. Like conventional antibodies, Nanobodies show high target specificity, high affinity for their target, and low inherent toxicity. Additionally, like small molecule drugs they have the opportunity to inhibit enzymes and readily access receptor clefts.
The Nanobody technology was developed following the discovery that camelidae (camels and llamas) 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 stable polypeptide harboring the full antigen-binding capacity of the original heavy-chain antibody, Ablynx reports.
These newly discovered VHH domains form the basis of Ablynx’ Nanobodies, which have a high homology with the VH domains of human antibodies and can be further humanized without any loss of activity.
Ablynx and Boehringer Ingelheim have a separate deal, which was inked in September 2007, to develop up to 10 Nanobodies in areas including immunology, oncology, and respiratory. At the time, Ablynx said it expected to receive payments of €75 million (roughly $92.76 million) during the research term, including a €15 million (approximately $18.56 million) equity investment. Both firms will propose target opportunities.
During 2009, Ablynx reported three milestone fees of €3 million (about $3.71 million) each. The company is eligible for development-related milestones of up to €125 million (roughly $154.63 million) for each Nanobody as well as undisclosed royalties. Similar to the Alzheimer disease deal, Boehringer Ingelheim has exclusively responsibility for developing, manufacturing, and commercializing any compounds resulting from the alliance. Ablynx will have certain co-promotion rights in Europe.