Argenx in US$1.6bn deal with J&J affiliate Janssen

Under the deal, Janssen will pay US$300m in cash to argenx for the global commercialisation rights of cusatuzumab, currently developed in in AML, MDS and other hematological malignancies. argenx will be eligible to receive potentially up to $1.3bn in development, regulatory and sales milestones as well as tiered, double-digit royalties. Furthermore, Johnson & Johnson Innovation Inc. (JJDC) aquired a US$200m stake in argenx shares. argenx retains the option to participate in commercialization efforts in the U.S., where the companies have agreed to share economics 50/50 on a royalty basis and outside the U.S., Janssen will pay double-digit sales royalties to argenx. 

Cusatuzumab is currently in development in a Phase I/II combination study with Vidaza® for newly diagnosed, elderly patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) who are unfit for chemotherapy. Data announced today from the Phase I/II study will be presented later today at the 60th American Society of Hematology Annual Meeting (ASH).

“Cusatuzumab offers a novel mode of action targeting leukemic stem cells, which are a known driver of the relapse mechanism, and has shown a compelling response rate and tolerability profile to date,” said Tim Van Hauwermeiren, CEO of argenx. 

At ASH, competitor BerGenBio presented Phase II headline results of its selective AXL inhibitor bemcentinib in 26 patients with relapsed/refractory AML or high-risk MDS. In AXL-positive patient population (14/26, 54%), bemcentinib monotherapy achieved a 43% response rate and showed  a mild and manageable side effect profile. In AML patients Argenx’ anti-TNFSF7 (CD70) antibody cusatuzumab achieved an overall response rate of 92%.