Argenx, based in Ghent, Belgium, announced a global collaboration and license deal with Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson.
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Argenx, based in Ghent, Belgium, announced a global collaboration and license deal with Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson.
The deal is for cusatuzumab (ARGX-110), a differentiated anti-CD70 SIMPLE antibody, which is presently in a Phase I/II clinical trial with Vidaza for newly disagnosed, elderly patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) who are not eligible for chemotherapy.
Argenyx is also presenting data from the trial during a workshop held in conjunction with the American Society of Hematology (ASH) Annual Meeting today.
Under the terms of the agreement, Janssen is paying Argenx $300 million up front, and buying $200 million in newly issued shares, which represents 4.68 percent of Argenx’s outstanding shares. Argenx will also be eligible for up to $1.3 billion in development, regulatory and sales milestones, as well as tiered, double-digit royalties.
Janssen will handle worldwide commercialization activities.
Of the clinical trial, Nicolas Leupin, Argenyx’s chief medical officer, stated, “We continue to be excited by the encouraging dataset from our Phase I/II trial of cusatuzumab in AML and MDS. This agent targets the CD70/CD27 pathway which has the potential to be a novel and selective mechanism in treating newly diagnosed AML patients regardless of age or cytogenetic profile. Today we are seeing a growing depth of responses from patients on cusatuzumab, with 10 out of 12 patients reaching complete response and eight of these 10 with hematologic recover, which patients tolerated well. Six patients remain on trial, and we will watch as these data mature, including the durability of responses.”
Cusatuzumab was well-tolerated in AML patients at four different dosing levels, 1 mg/kg, 3 mg/kg, 10 mg/kg and 20 mg/kg. The study showed an overall response rate (ORR) across the 12 patients of 92 percent, including 10 with a complete remission with or without hematologic recover (CR/Cri) and one patient had partial remission (PR). The median duration on trial as of the October 15, 2018 cut-off date was 8.1 months, ranging from two to 17.4 months. Six patients remain on trial. Five patients accomplished minimal residual disease (MRD) negativity as measured by flow cytometry and molecular genetics in the bone marrow.
The company is currently enrolling 21 AML patients in the Phase II part of its Phase I/II clinical trial using the 10 mg/kg dose of cusatuzumab.
Of the licensing deal, Tim Van Hauwermeiren, chief executive officer of Argenyx stated, “AML continues to be an aggressive and deadly cancer of the blood and bone marrow with very high relapse rates. 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.”
He went on to say, “Janssen is an ideal strategic partner for us to develop this differentiated investigational therapy given its extensive clinical, regulatory and commercial expertise in oncology, and we believe that through this collaboration we are best positioned to reach the broadest number of patients as quickly as possible. The collaboration also strengthens our financial position, enabling our growth into a fully-integrated organization as we continue to exploit our deep pipeline of wholly-owned product candidates, including our lead product candidate efgartigimod which we are evaluating in four severe autoimmune indications.”
