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Abbvie Helps Ablynx ‘Grow Up’ With $840M; Will Nanobody be Son of Humira?

By Nuala Moran
Staff Writer

LONDON – Ablynx NV signed an $840 million licensing deal with Abbvie Inc. for its ALX-0061 nanobody targeted against the cytokine interleukin-6 receptor (IL-6R), in the treatment of rheumatoid arthritis and systemic lupus erythematosus.

Of this, $175 million is to be paid up front, helping to fund completion of Phase II development by Ablynx, with $665 million in potential milestones up to commercialization to be followed by double-digit royalties on sales of any products to reach market.

“It’s a real growing up thing for us,” said Ed Moses, CEO of Ablynx. Apart from the cash and the endorsement of the single-domain antibody fragment nanobody platform, the deal will take Ablynx to the next stage of maturity. “For me it’s a real validation of the business plan set out 10 years ago. Then the aim was to get to clinical proof of concept, which we’ve now done two times. The next stamp of approval is to get a big pharma partner to buy in,” Moses told BioWorld Today.

He’s also pleased to be in charge of finishing Phase II development of the product after successfully completing a Phase IIa in February 2013, in which ALX-0061 showed strong efficacy and good safety data in patients with moderately to severely active rheumatoid arthritis on a stable background treatment of the steroid methotrexate. Three-quarters of the 37 patients in the trial achieved durable disease remission.

“It’s an opportunity because we get to do the rest of Phase II, so we get the experience and build the skills that help us develop the company to another level. We’ll take ALX-0061 to the point where it is Phase III-ready,” Moses said.

In addition, Moses believes Abbvie’s huge experience in rheumatology, with its world-leading rheumatoid arthritis drug Humira (adalimumab), makes it the ideal pharma partner. However, he was coy when asked if ALX-0061 will be the son of Humira. “That’s for Abbvie to say. It’s clear with the amount of cash they are prepared to put in they see a lot of potential, but there’s a long way to go yet.”

IL-6R is widely touted to become the successor to TNF-alpha as the target for the next generation of anti-inflammatory drugs. ALX-0061 would not be the first anti-IL-6R to market as a rheumatoid arthritis treatment, with Acemtra (tocilizumab) from F. Hoffman-La Roche the leader of the pack. But for Moses that is a good thing. “It’s a well-established target that is clearly seen as very important. We will benefit from the pioneering work done by people at Roche,” he said.

If not the first anti-IL-6R product, Ghent, Belgium-based Ablynx is certainly hoping that the small size of the ALK-0061 nanobody – at 26 kilodaltons – will make it more effective than full-scale monoclonal antibodies. The company says its diminutive size may potentially allow ALX-0061 to penetrate more effectively into tissues, while the monovalent interaction of the molecule with its target reduces the possibility of off-target effects. The product has a very strong affinity for soluble IL-6R, a property which should ensure speedy blocking of the target and a fast onset of effect. In addition, Ablynx says ALX-0061 appears to benefit from the general nanobody characteristic of low immunogenicity.

Under terms of the agreement, Ablynx is responsible for completing Phase II clinical development in both rheumatoid arthritis and systemic lupus erythematosus. If successful, Abbvie will then exercise the right to in-license ALX-0061 and take on Phase III clinical development and commercialisation.

In another sign of how the deal takes Ablynx to the next stage of corporate development, it has an option for co-promotion rights in Belgium, the Netherlands and Luxembourg. Moses said there will now be rapid forward development of ALX-0061, with the current plan being to start various clinical trials in both rheumatoid arthritis and systemic lupus erythematosus during the course of 2014 and 2015.

Following publication of the Phase IIa trial results for ALX-006 in February, Ablynx raised €31.5 million (US$41 million) in a private placement, boosting its reserves to around €90 million and allowing the company to progress development ALX-0061 into Phase IIb, while negotiating with potential partners.