Cusatuzumab (ARGX-110) is a checkpoint inhibitor targeting CD70.

Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson, has signed an agreement with clinical-stage biotechnology company argenx to collaborate on a joint global clinical development plan to evaluate cusatuzumab, a checkpoint inhibitor targeting CD70, in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and other potential future indications.

As part of the deal, which is expected to close in the first quarter of 2019, argenx will receive a $300 million upfront payment from Janssen, and Johnson & Johnson Innovation will purchase $200 million worth of newly issued shares representing 4.68% of argenx’s outstanding shares. argenyx will also be eligible to receive up to $1.3 billion in development, regulatory and sales milestone payments. Janssen will be responsible for global commercialization, while argenyx will retain the right to co-promote cusatuzumab in the United States and share economics 50–50 on a royalty basis. Outside the United States, Janssen will pay double-digit sales royalties to argenx.

Cusatuzumab (ARGX-110) is an investigational SIMPLE Antibody™ targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. It has a novel mode of action, targeting leukemic stem cells, a known driver of the relapse mechanism.

Currently cusatuzumab is being evaluated in a phase I/II combination study with Vidaza® (azacytidine, Celgene), an antineoplastic or cytotoxic chemotherapy drug, for the treatment of newly diagnosed, elderly patients with AML and high-risk MDS who are unsuitable for chemotherapy.