Pfizer has entered into an agreement with Japanese pharmaceutical firm Kyowa Hakko Kirin to carry out an immuno-oncology combination Phase Ib trial in patients with solid tumours.
Under the deal, Kyowa’s anti-CCR4 antibody mogamulizumab will be evaluated in combination with Pfizer’s investigational 4-1BB agonist PF-05082566 in this Phase Ib trial designed to evaluate the safety and tolerability of the combination in these patients.
Pfizer’s PF-05082566 is an investigational, fully humanised monoclonal antibody (mAb) that stimulates signalling through 4-1BB (CD-137), a protein involved in regulation of immune cell activation, proliferation and survival.
The trial to be conducted by Pfizer will be co-funded by the two firms and is expected to establish a recommended dose regimen and evaluate the safety and preliminary efficacy of the combination therapy.
The companies intend to initiate the trial in 2015 and the results will determine the future clinical development of the combination.
Pfizer Oncology senior vice-president of Clinical Development and Medical Affairs and chief medical officer Dr Mace Rothenberg: "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 maximise 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."
In pre-clinical models, PF-05082566 has shown anti-tumour activity by enhancing T-cell mediated immune responses.
Kyowa Hakko Kirin managing executive officer, vice-president, head of Research and Development Division Yoichi Sato said: "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.
"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."
Currently, Pfizer is evaluating PF-05082566 in a Phase I trial as a single agent in multiple tumour types, as well as in several combination studies, including a clinical study of PF-05082566 in combination with rituximab in non-Hodgkin lymphoma patients.