Date: 2013-06-21
Type of information: Treatment of the first patient
phase: 1
Announcement: dosing of the first patients
Company: Merck Serono (Germany)
Product: ALX-0761
Action
mechanism: Nanobodies are antibody-derived therapeutic proteins that contain the unique structural and functional properties of naturally-occurring heavy-chain antibodies. The Nanobody technology was originally 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 perfectly stable polypeptide harbouring the full antigen-binding capacity of the original heavy-chain antibody. These newly discovered VHH domains with their unique structural and functional properties form the basis of a new generation of therapeutic antibodies which Ablynx has named Nanobodies.
Disease: inflammatory diseases
Therapeutic area: Inflammatory diseases
Country:
Trial
details: The Phase I study involves a single-centre, randomised, double-blind, placebo-controlled trial to assess the safety, pharmacokinetics and pharmacodynamics of single ascending doses of subcutaneous injections with ALX-0761 in healthy subjects.
Latest
news: * On June 21, 2013, Ablynx has announced that its partner Merck Serono has dosed the first healthy volunteers in a Phase I clinical trial as part of the evaluation of the Nanobody®, ALX-0761, for the treatment of inflammatory diseases.
ALX-0761 is the first clinical Nanobody candidate to emerge from the collaboration which the companies entered into in 2008. The collaboration agreement allows Ablynx to convert, at certain time-points in the development, the 50-50 co-discovery and co-development collaboration into a license agreement. At this point, Ablynx has decided to convert this collaboration into a license agreement, and as a result, Merck Serono now has an exclusive worldwide license agreement for ALX-0761. Ablynx is eligible to receive additional development milestone payments associated with the progress of the product in multiple indications as well as regulatory and commercial milestones plus tiered royalties upon approval of the product. The start of the Phase I study triggers a €2.5 million milestone payment to Ablynx.
