News Feature | October 1, 2014

Pfizer And Kyowa Hakko Kirin To Combine Immuno-Oncology Drugs

By Estel Grace Masangkay


Pfizer announced that it has entered an agreement with Kyowa Hakko Kirin to explore the potential of the immuno-oncology combination of Kyowa’s mogamulizumab and Pfizer’s antibody PF-05082566 in patients with solid tumors.

Mogamulizumab is a humanized mAb targeting CC chemokine receptor 4 (CCR4). The antibody kills target cells using its antibody-dependent cellular cytotoxicity. Kyowa Hakko Kirin launched mogamulizumab in Japan two years ago as treatment for relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL). The company also secured approval for expanded indications and marketing authorization for mogamulizumab in Japan earlier this year.

PF-05082566 is an investigational fully humanized monoclonal antibody (mAb) that induces signaling through the protein 4-1BB (CD-137). The protein plays a part in regulation of immune cell activation, multiplication, and survival. Findings from pre-clinical models show that PF-05082566 has demonstrated anti-tumor activity by boosting T-cell mediated immune response. Pfizer is conducting a Phase I trial to study PF-05082566 as monotherapy in several tumor types as well as in combo therapies. These include PF-05082566 in combination with rituximab as treatment for non-Hodgkin lymphoma.

As part of the agreement, both Pfizer and Kyowa Hakko Kirin will contribute funding to the Phase 1B clinical study that will assess the combo therapy’s safety and tolerability. Pfizer will take the lead in conducting the clinical study which is expected to begin in 2015. The Phase 1B trial will aim to establish a recommended dose regimen and investigate the safety as well as the preliminary efficacy of the combination therapy.

Dr. Mace Rothenberg, SVP of Clinical Development and Medical Affairs, and CMO for Pfizer Oncology, said, “Our collaboration with Kyowa Hakko Kirin provides an additional important partnership opportunity to explore the potential of 4-1BB as part of a novel immunotherapy combination regimen.”

“With recent progress in the field of cancer immunotherapy, the combination therapy of mogamulizumab and Pfizer’s 4-1BB agonist has the potential to bring significant benefits to patients,” said Yoichi Sato, VP, Head of R&D Division of Kyowa Hakko Kirin. The company also entered into a separate immuno-oncology collaboration for mogamulizumab with British drugmaker AstraZeneca in July.

Pfizer and Kyowa Hakko Kirin said results from the Phase IB study will guide the future clinical development of the immuno-oncology combo.