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‘Good Week’ for Ablynx; Inks Merck Serono Discovery Deal

By Nuala Moran
Staff Writer

LONDON – Ablynx NV notched up a second deal last week, announcing a collaboration with Merck Serono under which a dedicated discovery unit will be set up at Ablynx.

Merck Serono is paying €11.5 million (US$15.5 million) up front to finance the creation of the unit and will provide a further 13.5 million over the next four years to fund the research.

Within that time the ambition is to deliver at least six programs with proof of principle in relevant animal models. Merck Serono will commit to taking at least four of those forward with Ghent, Belgium-based Ablynx in co-development agreements.

Last week, Ablynx announced an $840 million tie-up with Abbvie Inc. for ALX-0061, a treatment for rheumatoid arthritis and systemic lupus erythematosus. The product, which is the most advanced of the company’s single domain antibody fragments, or nanobodies, is targeted against the cytokine interleukin-6 receptor (IL-6R).

“It’s been a good week,” said Ed Moses, CEO. While this latest deal is very different in kind from that with Abbvie, it is the fourth collaboration Ablynx has signed with Merck Serono and is based on the good experience the biopharmaceutical division of Merck KGaA, of Darmstadt, Germany, has had with nanobodies since the two companies started working together in 2008.

“You can put up Powerpoints and talk to potential partners about the properties of nanobodies, but handling them tells a different story,” Moses told BioWorld International.

The first nanobody discovered in the earlier Ablynx/Merck Serono collaborations entered Phase I at the beginning of 2013. Bernhard Kirschbaum, head of global research and early development at Merck Serono, said that as a result of the long-running partnership both sides know how to design nanobody programs to ensure technology fit, differentiation potential and a clear scientific rationale. The goal “is to develop novel biologics with a high degree of differentiation for high value therapeutic targets,” Kirschbaum said.

Under previous deals, Merck Serono has paid Ablynx 10 million per project to develop nanobodies to targets it nominates. Under this new collaboration, both partners will be involved in target selection. “We wanted to set up a scheme whereby we can look together at targets that are less fully validated, to pick up earlier-stage ideas,” Moses said. “We will take [programs] to in vivo proof of principle in animals and can then choose to turn them into co-development programs, providing a pipeline for Ablynx.”

Having Merck Serono as a partner in the discovery effort is important because of the funding provided, but also because it gives Ablynx access to the pharma’s expertise. “We can discuss targets and indications with them, and also they have the animal models and the pharmacology skills.” Moses said.

In addition, Ablynx’s business plan is to out-license its programs, and working with Merck Serono from the start of discovery gives confidence that programs will be shaped to be of interest to potential future partners.

On Merck Serono’s part, the discovery collaboration will enable it to look at a broader field of targets than under the previous deals. “If Merck Serono is going to pay us 10 million to work on a target, they need to be pretty sure about that target, because there’s a risk,” Moses noted.

The targets in the discovery collaboration will span all of Merck Serono’s core research and development fields, including oncology, immunology and neurology, and will be sourced from academia and the literature. In addition, the flexibility of nanobodies will be used to approach known targets in different ways, for example, by building bivalent or trivalent constructs that engage targets in a novel fashion. Overall, Moses said, this approach could create substantial value for both parties. “It is a very interesting model and one which we believe could be applicable for us in other partnerships.”

The first contract between Ablynx and Merck Serono, signed in 2008, focused on two targets in oncology and immunology. That was followed by a second contract in 2010, adding a new program for an inflammatory diseases target. In November 2011, the two companies further cemented their relationship in an agreement to co-discover and co-develop nanobodies against two targets in osteoarthritis.