AstraZeneca and Kyowa Hakko Kirin partner on immuno-oncology clinical study

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.

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NOTES TO EDITORS

About MEDI4736
MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. MEDI4736 is being developed, alongside other immunotherapies (IMTs), to empower the patient’s immune system and attack the cancer.

About tremelimumab
Tremelimumab is an investigational, fully human monoclonal IgG2 antibody which binds to the protein CTLA-4, expressed on the surface of activated T cells. It is one of the only molecules in development for treating mesothelioma by blocking CTLA-4 to strengthen immune system response.

About mogamulizumab
Mogamulizumab is a novel, humanised monoclonal antibody directed against CC chemokine receptor 4. Engineered by Kyowa Hakko Kirin's unique POTELLIGENT® Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Mogamulizumab was launched in Japan in May 2012 for the treatment of patients with relapsed or refractory CCR4-positive Adult T-Cell Leukemia-Lymphoma (ATL). The drug was approved for indication expansion and was granted marketing authorisation for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014. Clinical trials with mogamulizumab in ATL, PTCL, and CTCL are ongoing in the US, EU and other countries.

About Kyowa-Hakko Kirin
Kyowa Hakko Kirin is a research-based life sciences company with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/ allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, we are working to realise our vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and comfort of people around the world. More information can be found at http://www.kyowa-kirin.com

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

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