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2014-07-30

AstraZeneca: 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
(http://www.astrazeneca.com/Media/Press-releases/Article/20140514--medimm...)
oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360 and
MEDI4736 with Advaxis'
(http://www.astrazeneca.com/Media/Press-releases/Article/20140721--tba)
immunotherapy vaccine, ADXS-HPV.

- ENDS -

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

CONTACTS

Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 (UK/Global)

Vanessa Rhodes +44 20 7604 8037 (UK/Global)

Ayesha Bharmal +44 20 7604 8034 (UK/Global)

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 2677 (US)

Investor Enquiries

Karl Hård +44 20 7604 8123  mob: +44 7789 654364

Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729

Anthony Brown +44 20 7604 8067 mob: +44 7585 404943

Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627

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