Bristol-Myers Squibb (BMS) and Kyowa Hakko Kirin said today they have begun a collaboration to conduct a Phase I/II study of an immuno-oncology combination therapy of the former’s Opdivo™ (nivolumab) and the latter’s mogamulizumab. The value of the collaboration was not disclosed.

The study—to be conducted by Kyowa Hakko Kirin in the U.S.—will assess the safety, tolerability, and anti-tumor activity of combining mogamulizumab and Opdivo in patients with advanced or metastatic solid tumors, BMS and Kyowa Hakko Kirin said.

The collaboration builds on an earlier clinical collaboration launched by the two companies and Ono Pharmaceutical in December 2014 to study the Opdivo/ mogamulizumab combination in Japan.

“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,” Yoichi Sato, director of the board, managing executive officer, vp, head of research and development division at Kyowa Hakko Kirin, said in a statement.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor type 4 (CCR4), sold in Japan under the brand name Poteligeo®. The antibody was engineered by Kyowa Hakko Kirin's Potelligent® Technology platform, designed to improve the potency and efficacy of antibody drugs.

Mogamulizumab was launched in Japan in 2012 for CCR4-positive adult T-cell leukemia-lymphoma (ATL). Last year, the drug was approved in Japan for an additional indication, relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). Clinical trials with mogamulizumab are ongoing in the U.S., the E.U., and other countries.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor approved by the FDA for two cancer indications. One is unresectable or metastatic melanoma and disease progression following the BMS drug Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. In March, Opdivo won approval for the additional indication of metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.








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