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April 21, 2016

AbbVie to Co-Develop Argen-X's Cancer Immunotherapy ARGX-115

  • AbbVie will partner to develop and commercialize argenx’s preclinical cancer immunotherapy ARGX-115 under a collaboration that could generate up to $685 million for the Dutch–Belgian biotech.

    ARGX-115 is a first-in-class human antibody targeting the novel immuno-oncology target GARP (glycoprotein A repetitions predominant), a membrane protein believed to enhance the immunosuppressive effects of T cells. The candidate has been developed by argenx with researchers at the de Duve Institute, located on the Brussels campus of the Université Catholique de Louvain (UCL).

    Preclinical studies by de Duve, UCL, and Walloon Excellence in Lifesciences and Biotechnology (WELBIO) have shown ARGX-115 can inhibit the immunosuppressive activity of human regulatory T cells by binding to the GARP-inactive transforming growth factor-β (TGF-β) complex and preventing release of active TGF-β.

    ARGX-115 was engineered through argenx’s SIMPLE Antibody™ platform, designed to source the variable or “V” regions of human antibodies from the immune system of outbred llamas, whose V regions are identical to those of humans.

    Because each llama has a different genetic background, each can generate a unique, individual immune response intended to provide a wide array of antibody V regions against potentially any target of interest—broadening the range of potential targets and antibody profiles that can be generated through the platform, argenx reasons.

    Under the collaboration, argenx agreed to conduct R&D through IND-enabling studies. Upon successful completion of these studies, AbbVie may exercise an exclusive option to license the ARGX-115 program and oversee further clinical development and commercialization.

    “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,” Anil Singhal, vp, early oncology development with AbbVie, said in a statement.

    The collaboration is AbbVie’s second cancer alliance announced in as many days. Yesterday, the biopharma giant joined the University of Chicago in launching a partnership intended to advance research in several areas of oncology—including, initially, breast, lung, prostate, colorectal, and hematological cancers.

    Should AbbVie not exercise its option to license ARGX-115, argenx retains the right to pursue development of ARGX-115 alone. Upon commercialization, argenx retains 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.

    AbbVie agreed to pay argenx $40 million upfront for the exclusive option to license ARGX-115, another $20 million in payments tied to unspecified near-term preclinical milestones, and up to $625 million tied to achieving development, regulatory, and commercial milestones. Also, argenx is eligible for tiered, up to double-digit royalties on net sales upon commercialization.

    In addition to ARGX-115, AbbVie agreed to fund further GARP-related research by argenx for an initial 2-year period. AbbVie will have the right to license additional therapeutic programs emerging from this research, for which argenx could receive associated milestone and royalty payments.

    “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,” added argenx CEO Tim van Hauwermeiren.

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