Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company
developing cancer immunotherapies, today announced that the
European Society of Gynaecologic Oncology (ESGO) has accepted an
abstract for a poster presentation at its 2017 congress on the
identification of potential baseline biomarkers indicative of
survival benefit from treatment with the company’s lead
immunotherapy candidate, axalimogene filolisbac. ESGO is Europe’s
landmark gynecologic oncology meeting. Held biennially, ESGO
congress brings together professionals to learn and discuss the
latest medical and scientific developments in gynecologic cancers
research, treatment and care.
Advaxis researchers identified certain pre-treatment baseline
levels of serum proteins that were strongly associated with overall
survival (OS) benefit in patients with persistent or recurrent
metastatic carcinoma of the cervix (PRmCC) that were treated with
axalimogene filolisbac in the Phase 2 GOG/NRG-0265 study. The
12-month survival rate in this study was 38 percent (19/50), and
these results were presented at a medical meeting earlier this
year.
This analysis of pre-treatment baseline serum proteins of 45
patients from the study showed that levels of a group of four
closely-aligned proteins were strongly correlated with OS. One
cluster of patients (n=25), had relatively lower levels of all four
proteins and exhibited an OS of 56 percent, while the second
cluster (n=20), with relatively higher levels, exhibited an OS of
15 percent. These data are statistically significant (HR=0.23; 95%
CI: 0.10-0.48; P<.001) and suggest that the baseline levels of
these analytes have prognostic value for OS, and high levels of
these individual proteins were negatively associated with clinical
outcomes in the trial.
Importantly, it was found that much of this effect was due to
levels of one particular protein, which was found to be most highly
correlated with OS in the study. This particular protein was
previously not known to be associated with survival in cervical
cancer. Advaxis will continue to evaluate this particular protein
as a potential biomarker to help identify patients most likely to
benefit from treatment with axalimogene filolisbac.
“In the field of cancer immunotherapy, biomarkers have been
playing an increasing role in guiding patient selection and
identifying early indicators of treatment response,” said Robert
Petit, Chief Scientific Officer of Advaxis. “The discovery of this
potential biomarker, which previously has not been known to be
associated with survival in cervical cancer, is significant and
could be a biomarker to predict efficacy, similar to how PD-L1
expression is used as a biomarker for checkpoint inhibitors. PD-L1
testing has become an important and routine strategy to guide
treatment, and this biomarker has the promise to do the same for
axalimogene filolisbac.”
Sandy Hayes, PhD, Associate Director of Research and Biomarker
Lead at Advaxis, is the first author and presenter of “Baseline
Serum Protein Levels Associated with Survival in Axalimogene
Filolisbac (Axal)-Treated Metastatic Cervical Cancer Patients: The
GOG/NRG-0265 Trial.” The poster will be presented at ESGO 2017,
held Nov. 4 to 7 in Vienna, Austria, and will also be published in
a supplement to the International Journal of Gynecological
Cancer.
About Cervical Cancer
Cervical cancer is the fourth most common cancer affecting women
worldwide. An estimated 13,000 cases were diagnosed in the United
States in 2016, and 4,100 women will have this disease as their
cause of death each year, according to the National Cancer
Institute. Decades of research have shown that persistent HPV
infection, particularly with high-risk virus types such as HPV-16
and HPV-18, is the most important factor in the development of
cervical cancer. The prognosis for women with advanced and
recurrent cervical cancer remains poor, with median survival of
only six to seven months following initiation of palliative
treatment with chemotherapy. According to the American Cancer
Society, the five-year survival rate for stage IV disease is at 15
to 16 percent. There is no approved therapy following failure of
first-line treatment, and there has been limited advancement in
developing new therapeutics for advanced cervical cancer over the
last 30 years.
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 while neutralizing the tumor’s natural
protections that guard the tumor microenvironment from immunologic
attack.
Axalimogene filolisbac has received Fast Track designation as an
adjuvant therapy for high-risk locally advanced cervical cancer
(HRLACC) patients and a Special Protocol Assessment for the Phase 3
AIM2CERV trial in HRLACC patients. Axalimogene filolisbac is the
only active product candidate to have received the U.S. FDA orphan
drug designation in cervical cancer.
Advaxis, in collaboration with Bristol-Myers Squibb, is
evaluating ADXS-DUAL, the next generation immunotherapy candidate
targeting HPV-associated cancers, with the PD-1 immune checkpoint
inhibitor, Opdivo (nivolumab), as a potential combination treatment
option for women with metastatic cervical cancer. Expected to start
by the end of 2017, the study will evaluate this combination
regimen in women with PRmCC who have failed at least one prior line
of systemic chemotherapy.
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a late-stage
biotechnology company developing multiple cancer immunotherapies
based on its proprietary Lm Technology™. 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 immunotherapies axalimogene filolisbac and ADXS-DUAL
target HPV-associated cancers and are in clinical trials for
invasive and metastatic cervical cancer, head and neck cancer and
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 enter the clinic 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
immunotherapies, axalimogene filolisbac and ADXS-DUAL. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170626005645/en/
Company:Advaxis, Inc.Noelle Heber, 609-250-7575Sr.
Director Corporate Communications and Government
Affairsheber@advaxis.comorMedia:JPA Health
CommunicationsDavid Connolly, 617-657-1301dconnolly@jpa.com
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