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AstraZeneca: Medimmune and Advaxis partner on immuno-oncology combination clinical trial

22 July 2014

AstraZeneca today announced that MedImmune, its global biologics
research and development arm, has entered into a clinical trial
collaboration with Advaxis, Inc., a US-based biotechnology company
developing cancer immunotherapies. The Phase I/II immunotherapy study
will evaluate the safety and efficacy of MedImmune's investigational
anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with
Advaxis' lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment
for patients with advanced, recurrent or refractory human
papillomavirus (HPV)-associated cervical cancer and HPV-associated
head and neck cancer.

Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of
treatments that use the body's own immune system to help fight
cancer. MEDI4736 is designed to counter the tumour's immune-evading
tactics by blocking a signal that helps tumours avoid detection,
while ADXS-HPV enhances the ability of immune cells to combat the
tumour. Preclinical evidence suggests that the combination of
ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can enhance
overall anti-tumour response.

"Our collaboration with Advaxis is further evidence of MedImmune's
commitment to explore novel combination approaches as we progress our
immuno-oncology portfolio," said Dr. Bahija Jallal, Executive Vice
President, MedImmune. "We believe there could be an important
clinical benefit from the combination of MEDI4736 with Advaxis's
antigen-specific cancer vaccine."

Under the terms of the agreement, MedImmune and Advaxis will evaluate
the combination as a treatment for HPV-associated cervical cancer and
squamous cell carcinoma of the head and neck. The Phase I part of the
trial is expected to establish a recommended dose regimen of MEDI4736
with ADXS-HPV, and the Phase II portion will assess the safety and
efficacy of the combination. The study will be funded and conducted
by Advaxis. Results from the study will be used to determine whether
further clinical development of this combination is warranted.

Under the terms of the deal, MedImmune has a non-exclusive
relationship with respect to HPV-driven tumour types. MedImmune has
first right of negotiation for future development of combinations
involving MEDI4736 and ADXS-HPV.

"We are excited to be partnering with MedImmune and evaluating
MEDI4736 in combination with our immunotherapy," said Daniel J.
O'Connor, Chief Executive Officer, Advaxis. "This is the first time a
PD-L1 checkpoint inhibitor will be used with a new class of
immunotherapies. As multiple companies vie for a competitive
advantage in the future PD-L1 market, the ability of our
immunotherapy platform to attack multiple tumour targets makes it an
attractive combination therapy."

AstraZeneca and MedImmune have recently initiated other
immuno-oncology combination trials, including a collaboration
with biopharmaceutical company Incyte to study MEDI4736 with Incyte's
oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360.

- ENDS -


About HPV-associated head and neck cancers

The incidence of HPV-associated head and neck cancers has been
increasing at an epidemic rate, while head and neck cancers from
other causes have been decreasing. According to the WHO,
approximately 15-20 percent of the 400,000 new cases of head and neck
cancer are HPV-related. In the US, there are about 12,000 new cases
of HPV-associated head and neck cancer per year and it affects men
about 3 times more frequently than women. HPV-associated head and
neck cancer is growing fastest in developed countries like the US.

About cervical cancer

There are 500,000 new cases of cervical cancer caused by HPV worldwide
every year, according to the WHO Human Papillomavirus and Related
Cancers, World Summary Report 2010. Current preventative vaccines
cannot protect the 20 million women who are already infected with
HPV, and of the high risk oncogenic strains, only HPV 16 and 18 are
present in these vaccines. Challenges with acceptance, accessibility,
and compliance have resulted in only a third of young women being
vaccinated in the US and even less in other countries around the
world. HPV is associated with 20-50 percent of oral squamous cell

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, to
empower the patient's immune system and attack the cancer.


ADXS-HPV is Advaxis's lead immunotherapy product candidate for the
treatment of HPV-associated cancers. It is currently under
investigation in three HPV-associated cancers: invasive cervical
cancer, head and neck cancer and anal cancer. In cervical cancer, a
recently completed Phase 2 study of ADXS-HPV demonstrated improved
survival and a manageable safety profile alone or in combination with
chemotherapy, which warrants further development of the molecule.
Clinical trials in head and neck cancer and in anal cancer are
ongoing. Advaxis has received Orphan Drug Designation from the US
Food and Drug Administration for ADXS-HPV for HPV-associated Stage
II-IV cervical cancer, head and neck cancer, and for anal cancer.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing multiple
cancer immunotherapies based on its proprietary platform that
redirects the immune system to kill cancer. The Advaxis technology,
using bioengineered live attenuated bacteria, is the only cancer
immunotherapy shown to actively suppress Tregs and MSDCs are key
components in the cancer microenvironment that contribute to tumour
growth and protect it from immunologic attack.

In addition to ADXS-HPV, Advaxis's second immunotherapy candidate,
ADXS-cHER2, targets the HER2 receptor, which is overexpressed in
certain solid-tumour cancers, including pediatric bone cancer (or
osteosarcoma), breast cancer, and gastric cancer. Advaxis is
developing ADXS-cHER2 for both human and animal-health, and has seen
promising results in canine osteosarcoma, a model for human bone
cancer. Advaxis is pursuing a clinical program in pediatric
osteosarcoma and has licensed ADXS-cHER2 and three other
immunotherapy constructs to a major animal-health company. For more
information, please visit

About MedImmune

MedImmune is the global 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

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:

Media Enquiries

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