Agreements

Date: 2017-04-13

Type of information: Milestone

Compound: ARGX-115

Company: Abbvie (USA - IL) Argen-X (Belgium)

Therapeutic area: Cancer - Oncology

Type agreement: development, commercialisation

Action mechanism: monoclonal antibody. ARGX-115 is a preclinical-stage human antibody program targeting the novel immuno-oncology target GARP, a protein believed to contribute to immuno-suppressive effects of T-cells. Tumors grow and progress as they escape from immune surveillance, owing to their ability to suppress the immune system by co-opting different immunosuppressive cells such as regulatory T-cells (Tregs), which can inhibit other immune effector cells through the production of active TGF-Beta. The membrane protein GARP play a key role in the regulation of production of active TGF-Beta by Tregs. Preclinical studies completed at de Duve Institute/UCL/WELBIO show ARGX-115 can inhibit the immunosuppressive activity of human Tregs by binding to GARP-inactive TGF-Beta complex and preventing release of active TGF-Beta. ARGX-115 was discovered under argenx' Innovative Access Program with the de Duve Institute / Université Catholique de Louvain /WELBIO.

Disease:

Details:

• • On April 21, 2016, AbbVie and argenx announced that they will collaborate to develop and commercialize ARGX-115. Under the terms of the agreement, argenx will conduct research and development through IND-enabling studies. Upon successful completion of these studies, AbbVie may exercise an exclusive option to license the ARGX-115 program and assume responsibility for further clinical development and commercialization. argenx has the right to co-promote ARGX-115-based products in the European Union and Swiss Economic Area and combine the product with its own future immuno-oncology programs. Should AbbVie not exercise its option to license ARGX-115, argenx retains the right to pursue development of ARGX-115 alone.
• In addition to the ARGX-115 program, and upon reaching a predetermined preclinical stage milestone, AbbVie will fund further GARP-related research by argenx for an initial period of two years. AbbVie will have the right to license additional therapeutic programs emerging from this research, for which argenx could receive associated milestone and royalty payments.

Financial terms: argenx will receive an upfront payment of $40 million from AbbVie for the exclusive option to license ARGX-115 and near-term preclinical milestones of $20 million. argenx is also eligible to receive additional development, regulatory and commercial payments up to $625 million upon achievement of pre-determined milestones as well as tiered, up to double-digit royalties on net sales upon commercialization.

Latest news: • On April 13, 2017, argenx announced the achievement of the first of two preclinical milestones on its way to the investigational new drug  filing of ARGX-115, triggering a first $ 10 million payment from AbbVie.

Is general: Yes