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2014-05-14

AstraZeneca: Medimmune and Incyte announce collaboration on immuno-oncology combination clinical trial

AstraZeneca today announced that MedImmune, its global biologics
research and development arm, has entered into a clinical study
collaboration with biopharmaceutical company Incyte Corporation. The
Phase I/II oncology study will evaluate the efficacy and safety of
MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor,
MEDI4736, in combination with Incyte's oral indoleamine dioxygenase-1
(IDO1) inhibitor, INCB24360.

Both MEDI4736 and INCB24360 are investigational compounds that 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
blocks the signals that help tumours avoid detection by the immune
system, countering the tumour's immune-evading tactics, while
INCB24360 enhances the ability of immune cells to combat the tumour.
Preclinical evidence suggests that the combination of these two
agents may lead to an enhanced anti-tumour immune response.

Under the terms of the agreement, MedImmune and Incyte will
collaborate on a non-exclusive basis on the study, to evaluate the
combination in multiple solid tumours including metastatic melanoma,
non-small cell lung cancer, squamous cell carcinoma of the head and
neck and pancreatic cancer. The Phase I part of the trial is expected
to establish a recommended dose regimen of both MEDI4736 and
INCB24360 and the Phase II part of the study will assess the safety
and efficacy of the combination. Results from the study will be used
to determine whether further clinical development of this combination
is warranted. The study will be co-funded equally by Incyte and
MedImmune and conducted by Incyte.

Dr. Bahija Jallal, Executive Vice President, MedImmune, said:
"Immuno-oncology is one of the most exciting areas in our industry
and we are progressing our strong pipeline as rapidly as possible.
Our partnership with Incyte is further evidence of our belief that
combination therapies have the potential to be one of the most
effective ways of treating cancer."

"Research collaborations that evaluate combinations of novel
immunotherapies across a broad range of indications have the
potential to accelerate our understanding of this rapidly evolving
field, to identify new areas of opportunity for immunotherapies, and
to more rapidly address the unmet needs of patients with a wide range
of cancers," said Hervé Hoppenot, President and Chief Executive
Officer of Incyte. "For these reasons, we welcome the opportunity to
work with MedImmune to explore the potential of combining MEDI4736
with INCB24360."

AstraZeneca and MedImmune have recently initiated other
immuno-oncology combination trials, including MEDI4736 with IRESSA
and MEDI4736 with tremelimumab. Other combination trials are planned
to start imminently, demonstrating the strength and rapid progression
of the company's immuno-oncology portfolio.

- 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 INCB24360

INCB24360 is an orally bioavailable small molecule inhibitor of IDO1
that has nanomolar potency in both biochemical and cellular assays,
potent activity in enhancing T lymphocyte, dendritic cell and natural
killer cell responses in vitro, with a high degree of selectivity.
INCB24360 has been shown to be efficacious in mouse models of cancer
as a single agent and in combination with cytotoxic and immunotherapy
agents, and its ability to reduce tumour growth is dependent on a
functional immune system - consistent with its proposed mechanism of
action. A Phase I dose-escalation trial demonstrated that INCB24360
results in greater than 90 percent inhibition of IDO1 activity at
generally well-tolerated doses.

INCB24360 is currently in Phase I/II development for metastatic
melanoma in combination with ipilimumab (www.clinicaltrials.gov
Identifier: NCT01604889) and as monotherapy for ovarian cancer
(www.clinicaltrials.gov Identifier: NCT01685255). Incyte has also
established a clinical agreement to combine INCB24360 with a novel
anti-PD-1 immunotherapy checkpoint inhibitor.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization
of proprietary small molecule drugs, primarily for oncology. For
additional information on Incyte, please visit the Company's website
at www.incyte.com.

About MedImmune

MedImmune is the worldwide biologics research and development arm of
AstraZeneca. MedImmune is pioneering innovative research and
exploring novel pathways across key therapeutic areas, including
respiratory, inflammation and autoimmunity; cardiovascular and
metabolic disease; oncology; neuroscience; and infection and
vaccines. The MedImmune headquarters is located in Gaithersburg, Md.,
one of AstraZeneca's three global R&D centres. For more information,
please visit www.medimmune.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

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