Argenx To Regain Global Rights To Anti-CD70 Antibody Cusatuzumab From Janssen's Cilag

argenx SE (ARGX), an immunology company, announced Monday that it will regain worldwide rights to its anti-CD70 antibody cusatuzumab from Cilag GmbH International, part of Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ).

The company noted that interim data from the Phase 1b ELEVATE trial support continued development in acute myeloid leukemia or AML. argenx plans to evaluate further options.

In was in 2018 that argenx and Janssen initiated the collaboration and licensing agreement to develop cusatuzumab to treat AML and myelodysplastic syndromes or MDS. Under the deal terms, argenx received $300 million in an upfront payment, approximately $200 million in an equity investment from Johnson & Johnson Innovation - JJDC, Inc., and $25 million in milestone payments to date.

argenx was notified of Janssen's decision to discontinue the collaboration deal during a regularly scheduled steering committee meeting on June 4. Following termination of the collaboration, argenx can elect that Janssen operationally support the treatment and follow-up of patients enrolled in ongoing cusatuzumab clinical trials.

The ongoing Phase 1b ELEVATE trial is evaluating cusatuzumab in combination with venetoclax and azacitidine in newly-diagnosed, elderly patients with AML. The intent-to-treat or ITT population included 44 patients.

Cusatuzumab was observed to be well-tolerated and the safety profile was consistent with prior studies. ELEVATE is ongoing, and the company will present complete results in an upcoming peer-reviewed forum.

The company further said that ongoing translational research on AML patient bone marrow samples from the Phase 2 CULMINATE trial show a decrease in primitive, monocytic-like blasts and leukemic stem cells, and an increase in normal myeloid cells, following treatment with cusatuzumab and azacitidine.

Tim Van Hauwermeiren, Chief Executive Officer of argenx, said, "We set our target high with the ELEVATE trial, recognizing that cusatuzumab would have to add benefit to an already-established combination regimen. We believe these interim data show that cusatuzumab could be meaningful to AML patients. 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."

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