argenx and AbbVie to collaborate on ARGX-115 against novel immuno-oncology target
21 April 2016 — AbbVie (NYSE:ABBV), a global biopharmaceutical company, and argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies to treat cancer and severe autoimmune diseases will collaborate to develop and commercialize ARGX-115. ARGX-115 is argenx’ preclinical-stage human antibody program targeting the novel immuno-oncology target GARP, a protein believed to contribute to immunosuppressive effects of T-cells.
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“ARGX-115 has been developed in collaboration with an outstanding team of academics at the de Duve Institute / Université Catholique de Louvain through our Innovative Access Program, which gives argenx rights to novel, exciting targets in our areas of therapeutic focus. We believe ARGX-115 has the potential to advance immuno-oncology by selectively targeting tumor immune escape pathways,” said Tim van Hauwermeiren, Chief Executive Officer of argenx. “We are proud to develop and commercialize ARGX-115 through collaboration with AbbVie, a global leader in oncology. In addition to the attractive financial elements of this transaction, our shared interest in the commercial potential of ARGX-115, including the right to co-promote the drug in Europe, makes this a highly strategic collaboration for argenx.”
“The ability to modulate the body’s own immune system to fight cancer is one of the most promising scientific advancements over the past decade,” said Anil Singhal, Vice President, Early Oncology Development, AbbVie. “We believe that the ARGX-115 program is a unique opportunity to explore the potential to block certain immune-suppressive pathways that allow cancers to grow.”
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 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. 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.
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-β. The membrane protein GARP plays a key role in the regulation of production of active TGF-β 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-β complex and preventing release of active TGF-β.
ARGX-115 was discovered under argenx’ Innovative Access Program with the de Duve Institute / Université Catholique de Louvain /WELBIO.
About the Innovative Access Program
Through the Innovative Access Program argenx collaborates closely with academic experts, bringing cutting edge antibody discovery technologies to the heart of novel target research. The extraordinary diversity of argenx’ SIMPLE AntibodyTM immune repertoires streamlines target validation, transforming novel proteins into next generation therapeutic antibody programs.