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.

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

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14 May 2014

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