Mogamulizumab is a new, humanized mAb directed against CC chemokine receptor type 4 (CCR4).
Opdivo is a PD-1 immune checkpoint inhibitor that has received approval from the US Food and Drug Administration (FDA) as a monotherapy in two cancer indications.
Conducted in the US, the trial will focus on evaluating the safety, tolerability and anti-tumor activity of combining mogamulizumab and Opdivo as a potential treatment option for these patients.
Before signing this agreement, Kyowa Hakko Kirin, Bristol-Myers and Ono Pharmaceutical entered into a clinical trial collaboration agreement to study the combination of mogamulizumab and Opdivo in Japan.
Both mogamulizumab and Opdivo are new immunotherapies designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system.
Kyowa Hakko Kirin Board Managing Executive Officer director, vice-president and Research and Development Division head Yoichi Sato said: "We are pleased to conduct a combination study with Bristol-Myers Squibb not only in Japan but also in the US.
"We believe that the planned combination of these two immunotherapies has the potential to deliver better outcomes in patients with advanced cancers than existing treatments."
The Phase I/II combination trial will be conducted by Kyowa Hakko Kirin.