Cilag International, a Janssen Pharmaceutical company, has opted to end its collaboration and licensing contract with Argenx for cusatuzumab, an experimental CD70- targeted antibody.
Janssen came to this conclusion after reviewing all existing data on cusatuzumab and considering it to be the standard treatment for AML (Acute Myeloid Leukemia).
The firms agreed to mutually manufacture and distribute cusatuzumab for AML, myelodysplastic syndrome and additional indications, in December 2018.
Johnson & Johnson granted Argenx a $300 million upfront payment, as well as a $200 million capital investment, according to the agreement. So far, the firm has received $25 million payments on achieving major milestones.
During a meeting of the executive committee on June 4th, Janssen informed Argenx of its decision to cancel the collaborative deal. The two businesses will work together to bring back the cusatuzumab production to Argenx.
Following the termination of the agreement, Argenx can acquire the functional assistance of Janssen pharmaceuticals to continue with the therapy and follow up in the ongoing clinical trials of cusatuzumab.
Cusatuzumab with venetoclax and azacitidine are being evaluated in a current phase lb ELEVATE trial in older people who are recently diagnosed with Acute Myeloid Leukemia.
A total of 44 people were included in the intent-to-treat population study. In preliminary efficacy evaluation, 48% of the 42 testable individuals attained Complete Remission (CR).
The interim results obtained from the ELEVATE study have encouraged the continuing production of cusatuzumab for the treatment of AML. The corporation will look into different possibilities for the drug’s future.
CEO of Argenx, Tim Van Hauwermeiren said: “We plan to evaluate all alternatives to advance cusatuzumab on behalf of the AML community while maintaining our focus on our priorities, the launch of efgartigimod, and the development of our autoimmune pipeline.”
In addition, translational studies on the bone marrow sample of AML patients from the phase 2 CULMINATE experiment of cusatuzumab+Azacytidine, found a decrease in rudimentary, leukemic stem cells and monocytic-like blasts, as well as an increase in normal myeloid cells.