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Agreements

Date: 2017-06-27

Type of information: Milestone

Compound: Nanobody candidates (including bi- and tri-specifics) directed toward immune checkpoint modulators

Company: Ablynx (Belgium) Merck&Co (USA - NJ)

Therapeutic area: Cancer - Oncology

Type agreement: research - R&D - licensing

Action mechanism: nanobody.

Disease:

Details:

  • • On February 3, 2014, Ablynx has announced that the company has entered into a second research collaboration and licensing agreement with a subsidiary of Merck & Co. This new exclusive collaboration and licensing agreement is focused on the discovery and development of several predefined Nanobody candidates (including bi- and tri-specifics) directed toward so called "immune checkpoint modulators," proteins believed to provide potential targets for the development of cancer immunotherapies.
  • In October 2012, Ablynx has already entered into a collaboration with Merck, through a subsidiary, to develop and commercialise Nanobody candidates directed towards a voltage gated ion channel with the option to develop and commercialise a Nanobody to a second target.

Financial terms:

  • Under the terms of the agreement, Ablynx will receive an upfront payment of €20 million and up to €10.7 million in research funding during the initial three year research term of the collaboration. In addition, Ablynx is eligible to receive development, regulatory and commercial milestone payments on achieved sales thresholds for a number of products with ultimate potential to accrue as much as €1.7 billion plus tiered royalties. Merck will be responsible for the development, manufacturing and commercialisation of any products resulting from the collaboration.
  • Under the terms of this four year expansion announced in July 2014, Ablynx will receive a €13 million upfront payment comprising exclusivity fees and FTE payments as well as further research funding over the term of the collaboration. In addition, Ablynx will be eligible to receive additional exclusivity fees, depending on the number of programmes for which Merck decides to exercise its licensing option, plus development, regulatory and commercial milestone payments of up to €340 million per programme, as well as tiered royalties on annual net sales upon commercialisation of any Nanobody products. Merck&Co will be responsible for clinical development, manufacturing and commercialisation of any products resulting from the collaboration.

Latest news:

  • • On June 27, 2017, Ablynx announced that Merck & Co has started an IND-enabling toxicology study with a bi-specific Nanobody® as part of the immuno-oncology collaboration between the companies. This milestone triggers a €2.5 million payment to Ablynx. This Nanobody is a bi-specific molecule that selectively binds to two different immune modulators, believed to be key targets for the development of potent immunotherapies. Upon successful completion of the IND package, this bi-specific Nanobody could be the first candidate to enter clinical studies as part of this collaboration.
  • • On October 15, 2015, Ablynx announced that it has achieved pre-clinical proof-of-concept with a Nanobody construct as part of its immuno-oncology collaboration with Merck & Co, triggering a €3.5 million milestone payment to Ablynx. This collaboration with Merck includes the discovery and development of up to 17 Nanobody programmes against individual protein targets and target combinations (mono-specific and multi-specific Nanobodies) for application in immuno-oncology indications. This Nanobody construct is a selective bi-specific molecule that potently binds to two different immune modulators, proteins believed to be targets for the development of important cancer immunotherapies. The results from the pre-clinical study in relevant tumour models demonstrated that this bi-specific Nanobody construct potently inhibits tumour growth.
  • * On July 22, 2015, Ablynx announced an expansion of its immuno-oncology collaboration with Merck&Co to address an increased number of immune checkpoint modulator targets. The original collaboration announced in February 2014 focused on the discovery and development of five pre-defined Nanobody candidates (including multi-specific Nanobody combinations) directed towards immune checkpoint modulator targets for evaluation as immunotherapies for cancer.
  • As part of this expansion of the 2014 agreement, Ablynx will be responsible for the discovery and development of up to 12 additional Nanobody programmes against individual protein targets and target combinations (mono-specific and multi-specific Nanobodies) through to the in vivo pre-clinical proof-of-concept stage, after which Merck&Co will have the option to advance specified lead candidates.
 

Is general: Yes