Advaxis and MedImmune Partner on Immuno-Oncology Combination Clinical Trial
PRINCETON, N.J., July 22, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc.
(Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer
immunotherapies, has entered into a clinical trial collaboration with
MedImmune, the global biologics research and development arm of AstraZeneca.
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
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
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."
About HPV-associated head and neck cancer
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% 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 in the
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 United States and even
less in other countries around the world. HPV is associated with 20-50% of
oral squamous cell carcinomas.
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
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.
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 www.medimmune.com.
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.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing multiple cancer
immunotherapies based on its proprietary platform intended to redirect the
immune system to kill cancer. The Advaxis Lm-LLO technology, using
bioengineered live attenuated listeria monocytogenes bacteria, is the only
known cancer immunotherapy shown in preclinical studies to neutralize Tregs
and MSDCs, that protect the tumor microenvironment from immunologic attack and
contribute to tumor growth. Advaxis's lead immunotherapy, ADXS-HPV, targets
human papillomavirus (HPV)-associated cancers and is in clinical trials for
three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and
neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan
drug status for each of these three indications. The Company plans to initiate
a registrational clinical program for cervical cancer in 2014 and has
established licensing partners in India and Asia for commercialization in
Advaxis's second immunotherapy candidate in clinical testing will be ADXS-PSA,
which is being developed to address prostate cancer. Advaxis is planning to
file an IND with the FDA and initiate a Phase 1 clinical study with ADXS-PSA
in 2014. Advaxis is also developing ADXS-cHER2, to target Her2 receptor
over-expressing cancers. Her2 is overexpressed in certain solid-tumor cancers,
including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal,
and gastric cancers. Advaxis is developing ADXS-cHER2 for both human and
animal-health, and has seen promising results in canine osteosarcoma, which is
considered 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. Advaxis is planning
to file an IND for ADXS-cHER2 in Her2 overexpressing cancers.
For more information please visit www.advaxis.com or connect with us on
This news release contains forward-looking statements, including, but not
limited to: statements regarding Advaxis's ability to develop the next
generation of cancer immunotherapies; the safety and efficacy of Advaxis's
proprietary immunotherapy, ADXS HPV; whether Advaxis immunotherapies can
redirect the powerful immune response all human beings have to the bacterium
to cancers. These forward-looking statements are subject to a number of risks,
including the risk factors set forth from time to time in Advaxis's SEC
filings, including but not limited to its report on Form 10-K for the fiscal
year ended October 31, 2013, which is available at http://www.sec.gov. Advaxis
undertakes no obligation to publicly release the result of any revision to
these forward-looking statements, which may be made to reflect the events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events, except as required by law. You are cautioned not to
place undue reliance on any forward-looking statements.
CONTACT: Advaxis Contact:
Senior Director of Investor Relations
and Corporate Communications
Tiberend Strategic Advisors, Inc.
Amy S. Wheeler
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