EMA Certification Paves the Way for the MAA Submission for Axalimogene Filolisbac in Metastatic Cervical Cancer
March 23 2017 - 8:00AM
Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing
cancer immunotherapies, today announced the European Medicines
Agency (EMA) issued an advanced therapy medicinal product
certificate for manufacturing quality and non-clinical data.
The certification procedure involved a thorough scientific
evaluation over several months of the quality (CMC) data and
non-clinical data by the EMA’s Committee for Advanced Therapies
(CAT). After a positive opinion from CAT, EMA issued a
certificate confirming that the CMC and non-clinical data comply
with the standards that apply for evaluating the Marketing
Authorization Application (MAA) of axalimogene filolisbac for the
treatment of metastatic cervical cancer. Advaxis is now
positioned to file the complete MAA in the second half of 2017.
“EMA’s issuance of this certification is a major
milestone for Advaxis,” said Daniel J. O’Connor, President and
CEO. “With a significant portion of the MAA now reviewed and
certified, we are preparing to file the complete MAA as we work to
bring this innovative immunotherapy to patients with metastatic
cervical cancer who have limited treatment options.”
About Axalimogene Filolisbac
Axalimogene filolisbac is a targeted Listeria
monocytogenes (Lm)-based immunotherapy that attacks HPV-associated
cancers by altering a live strain of Lm bacteria to generate
cancer-fighting T cells against cancer antigens while neutralizing
the tumor’s natural protections that guard the tumor
microenvironment from immunologic attack. In a phase 2 trial
evaluating axalimogene filolisbac for the treatment of persistent
or recurrent metastatic (squamous or non-squamous cell) carcinoma
of the cervix (PRmCC), the drug candidate showed a 12-month overall
survival rate of 38 percent observed in 50 patients in the trial.
This is a 52 percent improvement over the 12-month overall
survival rate that was expected in the trial’s patient population
based on prognostic factors.
Axalimogene filolisbac has received Fast Track
designation for adjuvant therapy for high-risk locally advanced
cervical cancer (HRLACC) and a Special Protocol Assessment for the
Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy
has also received orphan drug designation in three clinical
indications.
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a
biotechnology company developing multiple cancer immunotherapies
based on its proprietary Lm Technology™.
The Lm Technology, using bioengineered live
attenuated Listeria monocytogenes (Lm) bacteria, is the
only known cancer immunotherapy agent shown in preclinical studies
to both generate cancer fighting T cells directed against cancer
antigens and neutralize Tregs and myeloid-derived suppressor cells
(MDSCs) that protect the tumor microenvironment from immunologic
attack and contribute to tumor growth. Advaxis'
lead Lm Technology immunotherapy, axalimogene filolisbac,
targets HPV-associated cancers and is in clinical trials for three
potential indications: Phase 3 in invasive cervical cancer, Phase 2
in head and neck cancer, and Phase 2 in anal cancer. The FDA has
granted axalimogene filolisbac orphan drug designation for each of
these three clinical settings, as well as Fast Track designation
for adjuvant therapy for HRLACC patients and a SPA for the Phase 3
AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also
been classified as an advanced therapy medicinal product for the
treatment of cervical cancer by the EMA’s CAT. Advaxis has two
additional immunotherapy products: ADXS-PSA in prostate cancer and
ADXS-HER2 in HER2 expressing solid tumors, in human clinical
development. In addition, Advaxis and Amgen are developing
ADXS-NEO, an investigational cancer immunotherapy treatment
designed to activate a patient's immune system to respond against
the unique mutations, or neoepitopes, contained in and identified
from each individual patient's tumor, with plans to commence a
Phase 1 clinical trial in 2017.
To learn more about Advaxis, visit
www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and
YouTube.
Advaxis Forward-Looking Statement
This press release contains forward-looking
statements, including, but not limited to, statements regarding
Advaxis’ ability to develop the next generation of cancer
immunotherapies, and the safety and efficacy of Advaxis’
proprietary immunotherapy, axalimogene filolisbac. These
forward-looking statements are subject to a number of risks
including the risk factors set forth from time to time in Advaxis’
SEC filings including, but not limited to, its report on Form 10-K
for the fiscal year ended October 31, 2016, which is available at
http://www.sec.gov.
Any forward-looking statements set forth in this
presentation speak only as of the date of this presentation. We do
not intend to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof
other than as required by law.
You are cautioned not to place undue reliance on
any forward-looking statements.
CONTACTS:
Company:
Advaxis, Inc. Ranya Dajani, Vice President, Business Development
dajani@advaxis.com 609.250.7559
Media Contact:
JPA Health Communications David Connolly dconnolly@jpa.com
617.945.9316
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