AstraZeneca today announced that it has entered into a clinical study collaboration with Kyowa Hakko Kirin for a Phase I/Ib immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumours.
The study will evaluate AstraZeneca’s anti-PD-L1 antibody, MEDI4736, in combination with Kyowa Hakko Kirin’s anti-CCR4 antibody, mogamulizumab, and AstraZeneca’s anti-CTLA-4 antibody tremelimumab, in combination with mogamulizumab.
MEDI4736, tremelimumab, and mogamulizumab are part of a new class of cancer treatments known as immunotherapies, which use the body's own immune system to help fight cancer. MEDI4736 and tremelimumab block the signals that help tumours avoid detection by the immune system, while mogamulizumab suppresses some of the immune cells that shield the tumour from the immune system.
Under the terms of the agreement, AstraZeneca and Kyowa Hakko Kirin will co-fund the study, which will be conducted by Kyowa Hakko Kirin. The Phase I part of the study is expected to establish a recommended dose regimen and Phase Ib will assess the safety and efficacy of the two combinations. Results from these studies will determine the future clinical development of the combinations.
Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca, said: “We believe that combination therapy in immuno-oncology has the potential to be one of the most effective ways of treating cancer. Our partnership with Kyowa Hakko Kirin provides the opportunity to explore two novel and exciting combinations.”
“With recent progress in the field of cancer immunotherapy, we have the potential to bring significant benefits to patients,” said Yoichi Sato, Managing Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. “Given the potential synergistic activity of our anti-CCR4 antibody when combined with immune checkpoint inhibitors, we look forward to collaborating with AstraZeneca to explore these combinations in multiple types of cancer.”
AstraZeneca and MedImmune have a broad programme of immuno-oncology combination trials underway, including MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360 and MEDI4736 with Advaxis’ immunotherapy vaccine, ADXS-HPV.