GHENT, Belgium, 11 October 2010 – Ablynx [Euronext Brussels: ABLX] and Merck Serono, a
division of Merck KGaA, Darmstadt, Germany, today announced that they have expanded their
relationship and entered into a second agreement, to co-discover and co-develop Nanobodies against
an inflammatory disease target.
Ablynx’s Nanobodies are an innovative class of antibody-derived therapeutic proteins that combine
the advantages of conventional antibodies with key properties of small molecule drugs such as high
affinity, small size allowing alternative delivery and enhanced tissue penetration and high stability.
In September 2008, Merck Serono and Ablynx entered into an agreement to co-discover and co-
develop Nanobodies against two targets in oncology and immunology. This second agreement focuses
on the discovery and development of Nanobody-based therapeutics against an inflammatory disease
target. This new collaboration structure allows Ablynx to drive the process up to the clinic, leveraging
its strengths in Nanobody discovery and preclinical development.
Under the terms of the agreement, Ablynx will receive an up-front payment of €10 million and be
responsible for all activities and costs, excluding manufacturing costs, up to the delivery of a
preclinical package that will form the basis for the filing of an IND or IND equivalent. Upon
acceptance of the package by Merck Serono, Ablynx will be eligible for a €15 million milestone
payment. Ablynx has the option to continue with Merck Serono up to a 50:50 co-development basis
and share the resulting profits, or to convert this collaboration into an exclusive, worldwide licensing
deal with milestone payments and significant tiered royalties. Further details of the agreement are
undisclosed.
“We are very pleased with the progress made to date in our existing collaboration with Ablynx in
oncology and immunology and look forward to expanding it to the area of rheumatology where our
research focuses on proteins that modulate key pathogenic mechanisms. We believe that the specific
features of Nanobodies have the potential to address some of the challenges in treating autoimmune
and inflammatory diseases in general, and rheumatology in particular,” said Dr Bernhard Kirschbaum,
Executive Vice President Research and Development at Merck Serono.
GHENT, Belgium, 30 September 2010 - Ablynx [Euronext Brussels: ABLX] today announced that it
has opened recruitment in its first clinical trial centre for an open-label, randomised Phase II study for
patients with acquired thrombotic thrombocytopenic purpura (TTP). This Phase II study will be conducted
in Europe and North America and it is planned to enroll over 100 patients. Ablynx’s anti-von Willebrand
factor (vWF) Nanobody® was granted orphan drug designation for the treatment of TTP in May 2009, by
both the U.S. Food and Drug Administration and the European Commission.
During the Phase II study, the Nanobody will be administered to TTP patients as an adjunct to standard
plasma exchange therapy. The primary endpoint of the study will be the time to response, defined by the
normalisation of platelet count and the blood marker lactate dehydrogenase (LDH). The study goal is to
see a significant reduction in the time to response for the anti-vWF treated population compared with
placebo treatment. It is anticipated that this could translate into a shorter duration of life-threatening
episode, a reduction of the number of plasma exchanges required and the amount of plasma product
administered.
Dr Edwin Moses, CEO and Chairman of Ablynx commented: “There is currently no drug treatment
approved specifically for TTP. Patients are often hospitalised for up to two weeks and have to receive
frequent plasma exchanges which are costly and can lead to serious side effects such as allergic reactions
or infections. Despite the plasma exchange treatment, the condition is very serious with up to 20%
mortality. 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.” He added: “This is the third Nanobody programme
entering Phase II clinical trials.”
Coordinating investigator Professor Peyvandi from the IRCCS Maggiore Hospital Foundation in Milan
added: “We are very excited that the centre of Dr Dierickx, at the University Hospitals Leuven in
Belgium, is the first to be activated for recruitment in this study. This TTP study investigates a novel
treatment approach that could have an important impact on the future treatment of our TTP patients.” |
