Ablynx said today it will join with a Merck & Co. subsidiary to develop several new cancer drugs based on therapeutic proteins made of single-domain antibody fragments, or Nanobodies®, in a collaboration that could net the Belgian biopharma more than €1.7 billion (about $2.3 billion).

 The collaboration – the second between the companies – will focus on the discovery and development of several predefined Nanobody candidates (including bi- and tri-specifics) directed toward immune checkpoint modulators, proteins believed to provide potential targets for the development of cancer immunotherapies.

While the checkpoints modulate immune response to prevent undue damage under normal conditions, cancer tumors have been shown to co-opt several different immune-checkpoint pathways as a major mechanism to subvert immune responses. The companies reason that since many of the immune checkpoints are initiated by ligand-receptor interactions, they should be well-suited to targeting by biologics, especially multi-targeting agents such as Nanobodies.

Under the companies’ exclusive collaboration and licensing agreement, Merck agreed to pay Ablynx €20 million ($27 million) upfront, and up to €10.7 million ($14.4 million) in research funding during the initial three -year research term. Ablynx is also eligible to receive development, regulatory and commercial milestone payments on achieved sales thresholds for a number of products, plus tiered royalties.

Merck will be responsible for the development, manufacturing and commercialization of any products resulting from the collaboration.

“We are pleased to have expanded our relationship with Merck beyond the collaboration we signed in 2012. It demonstrates the potential of our Nanobody platform and how it can be used to discover and develop therapeutics in important areas of unmet medical need,” Ablynx CEO Edwin Moses, Ph.D., said in a statement.

The cancer collaboration comes more than a year after the companies’ neuroscience collaboration. In October 2012, Ablynx and Merck agreed to develop and commercialize Nanobody candidates directed towards a voltage gated ion channel, with the option to develop and commercialize a Nanobody to a second target. Ion channels are involved in a variety of conditions that include neurological disorders, hypertension, diabetes, cancer and arrhythmia.

In the earlier collaboration, Merck agreed to pay Ablynx €6.5 million (about $8.8 million) upfront and a €2 million ($2.7 million) fee for research funding. Ablynx is eligible for up to €448 million (about $605 million) in research, regulatory and commercial milestone payments associated with the progress of multiple candidates as well as tiered royalties on any products derived from the collaboration. Ablynx agreed to oversee discovery of Nanobody candidates, with Merck responsible for the research, development, manufacturing and commercialization of any Nanobody product resulting from their collaboration.

Ablynx said seven Nanobodies in clinical development as well as some 30 research programs in its pipeline, including ongoing collaborations with and seven Nanobodies in clinical development. Ablynx has ongoing research collaborations and significant partnerships with pharma giants that include AbbVie, Boehringer Ingelheim, Eddingpharm, Merck Serono and Novartis, in addition to Merck & Co.

“This collaboration positions Merck to expand our early oncology pipeline by developing innovative candidates based on Ablynx’s Nanobody technology,” added Roger M. Perlmutter, M.D., Ph.D., president of Merck Research Laboratories.








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