Pfizer Inc. and Kyowa Hakko Kirin have announced a collaboration to further develop Pfizer’s PF-05082566, an investigational, fully humanized monoclonal antibody (mAb), together with Kyowa Hakko Kirin’s anti-CCR4 antibody mogamulizumab, in a Phase 1b clinical trial to assess the safety and tolerability of this combination treatment in patients with different types of solid tumors.
The study will be co-funded by both companies and is expected to begin in 2015, with the out coming results determining the future research of this combination therapy.
PF-05082566 is an experimental, fully humanized mAb that specifically binds 4-1BB (CD-137), a costimulatory receptor present in different types of immune cells. Several studies have already demonstrated that enhancing T-cell immune responses results in significant anti-tumoral activity.
Pfizer has an ongoing Phase 1 trial evaluating PF-05082566 efficacy as a single agent in different types of tumors, and as a combination therapy with rituximab in non-Hodgkin lymphoma patients.
Mogamulizumab is a humanized mAb that specifically targets the chemokine receptor 4 (CCR4). This antibody has been designed using Kyowa Hakko Kirin’s POTELLIGENT® Technology, and can kill tumor cells via antibody-dependent cellular cytotoxicity, a mechanism that allows immune cells to kill target cancer cells in the presence of antibodies.
Mogamulizumab is already commercialized in Japan for the treatment of CCR4-positive adult T-cell leukemia-lymphoma, CCR4-positive, peripheral T-cell lymphoma and cutaneous T-cell lymphoma, and is currently being evaluated in clinical trials in the U.S., E.U. and other countries.
“We believe that combination therapy in immuno-oncology holds great promise to improve outcomes for patients with cancer and provides an exciting opportunity for Pfizer to maximize the potential of our emerging immuno-oncology portfolio. 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”, Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology said in a Pfizer press release.
“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,” added Yoichi Sato, managing executive officer, vice president, Head of Research and Development Division of Kyowa Hakko Kirin. “Collaborating with Pfizer, a world’s leading pharmaceutical company, on a clinical study in emerging immuno-oncology field is an important component of Kyowa Hakko Kirin’s ongoing transformation into a global specialty pharmaceutical company. We are excited about this opportunity.”