Advaxis Submits Conditional Marketing Authorization Application for Axalimogene Filolisbac for the Second-Line Treatment of M...
February 13 2018 - 8:30AM
Business Wire
- Advaxis reaches important regulatory
milestone for axalimogene filolisbac with submission of Conditional
MAA to treat metastatic cervical cancer in patients who progress
beyond first-line therapy
- The MAA submission is centered around
the encouraging results from the GOG-0265 study
- Each year, more than 24,000 women in
Europe die from metastatic cervical cancer1
Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology
company focused on the discovery, development and commercialization
of cancer immunotherapies has submitted a conditional Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) for the company’s lead Lm Technology product candidate,
axalimogene filolisbac, for the treatment of adult women who
progress beyond first-line therapy of persistent, recurrent or
metastatic carcinoma of the cervix (PRmCC).
“The submission of the MAA represents a significant regulatory
milestone for Advaxis and the ongoing development of our Lm
Technology Platform,” stated Anthony Lombardo, interim Chief
Executive Officer of Advaxis. “The submission is based on the
improvement in 12-month survival rates observed in the Phase 2
GOG-0265 study. We feel that these data support axalimogene
filolisbac as a potential therapeutic option for patients living
with PRmCC who are in desperate need of new treatment options
beyond first-line therapy,” added Lombardo.
The MAA submission is built around data from the GOG-0265 study
which examined overall survival rates in 50 women and showed a
12-month overall survival rate (primary efficacy endpoint) of 38%
(n=19/50) in women with PRmCC, representing a 55% improvement over
an expected, model-predicted,12-month survival rate of 24.5%.2 More
than 50% of treated women in this study had previously received
multiple prior lines of therapy including treatment with
bevacizumab and subsequently experienced progression of their
disease.2
“Despite the availability of preventative measures, metastatic
cervical cancer continues to be a major public health concern
associated with high mortality rates within Europe,” said Mansoor
Mirza, M.D., Chief Oncologist at the Copenhagen University Hospital
in Denmark and Medical Director of the Nordic Society of
Gynaecological Oncology (NSGO). “The results from GOG-0265 are
encouraging and could represent a meaningful step forward in the
care of women suffering from PRmCC, which has seen very little
innovation in almost 30 years.”
In the GOG-0256 study, axalimogene filolisbac was generally
well-tolerated with mostly Grade 1 and 2 flu-like adverse events
associated with cytokine release which were managed with standard
medical care. This safety profile is consistent with the ongoing
clinical experience of axalimogene filolisbac across all clinical
trials.
The EMA will evaluate the totality of the data, including
results from GOG-0265 as well as supportive data from other
clinical trials evaluating axalimogene filolisbac. In parallel with
the MAA review process, the company will continue assessing
partnership opportunities for the potential commercialization of
axalimogene filolisbac in Europe.
The company has also decided to align and simplify its strategy
by using axalimogene filolisbac exclusively in all ongoing and
planned HPV-related cancer clinical trials, including the upcoming
ADVANCE trial, previously planned with ADXS-DUAL. The strategic
decision to harmonize all trials to axalimogene filolisbac is based
on its clinical profile to date in over 250 patients, and its
demonstration of similar activity in both HPV 16 and 18 subtypes in
GOG-0265. The company believes that harmonizing to a single product
candidate for all HPV-related programs will streamline
developmental, regulatory and commercialization strategies.
About Axalimogene Filolisbac
Axalimogene filolisbac is a targeted Listeria monocytogenes
(Lm)-based investigational 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.
Axalimogene filolisbac has already achieved multiple regulatory
milestones, including classification as an EMA advanced
therapy-medicinal product for the treatment of cervical cancer,
receipt of the U.S. Food and Drug Administration (FDA) Fast Track
Designation as an adjuvant therapy for treating high-risk, locally
advanced cervical cancer (HRLACC), receipt of a Special Protocol
Assessment agreement with the FDA for the Phase 3 AIM2CERV trial,
and orphan drug designations in three HPV-associated indications
(PRmCC, head and neck, and anal cancer). In addition, axalimogene
filolisbac will be studied in combination with nivolumab in the
ADVANCE trial, a potential registrational trial for patients with
PRmCC, which is planned to begin in 2018.
About Advaxis, Inc.
Advaxis, Inc. is a late-stage biotechnology company focused on
the discovery, development and commercialization of
proprietary Lm-based antigen delivery products. These
immunotherapies are based on a platform technology that utilizes
live attenuated Listeria monocytogenes (Lm) bioengineered to
secrete antigen/adjuvant fusion proteins. These Lm-based
strains are believed to be a significant advancement in
immunotherapy as they integrate multiple functions into a single
immunotherapy, and are designed to access and direct antigen
presenting cells to stimulate anti-tumor T-cell immunity, activate
the immune system with the equivalent of multiple adjuvants and
simultaneously reduce tumor protection in the tumor
microenvironment to enable the T cells to eliminate tumors. Advaxis
has four franchises in various stages of clinical and near-clinical
development: HPV-associated cancers, individualized neoantigen
immunotherapy, cancer-specific hotspot mutation immunotherapies and
prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect
on Twitter, LinkedIn, Facebook, and YouTube.
References
1. Ferlay J, et al. Eur J Cancer 2013;49:1374-403.2. Huh W, et
al. Presented at the Annual Meeting on Women’s Cancer. March 12-15,
2017.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements regarding Advaxis’
ability and strategies to develop and commercialize cancer
immunotherapies, timing of planned clinical trials and regulatory
milestones, potential partnership opportunities and the safety and
efficacy of Advaxis’ proprietary immunotherapies. 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, 2017, which is available
at www.sec.gov.
Any forward-looking statements set forth in this press release
speak only as of the date of this press release. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180213005807/en/
Company:Advaxis, Inc.Noelle Heber, 609-250-7575Sr.
Director Corporate Communications and Government
AffairsHeber@advaxis.comorMedia:Stern Strategy GroupBrian
Hyland, 908-325-3891Bhyland@sternstrategy.comorRachel Auerbach,
908-325-3898Rauerbach@sternstrategy.comorInvestors:LHA
Investor RelationsAnne Marie Fields,
212-838-3777afields@lhai.com
Ayala Pharmaceuticals (CE) (USOTC:ADXS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Ayala Pharmaceuticals (CE) (USOTC:ADXS)
Historical Stock Chart
From Sep 2023 to Sep 2024