Advaxis Provides Phase 1 Data of Higher Dose Axalimogene Filolisbac
May 15 2017 - 8:00AM
Business Wire
Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing
cancer immunotherapies, today published online a poster previously
presented at the National Cancer Research Institute (NCRI) Cancer
Conference in Liverpool that showed axalimogene filolisbac achieved
durable response in a patient with persistent or recurrent
metastatic (squamous or non-squamous cell) carcinoma of the cervix
(PRmCC).
Sharad Ghamande, MD, principal investigator and Professor and
Director of Gynecologic Oncology at the Georgia Cancer Center at
Augusta University, discussed cervical cancer and axalimogene
filolisbac in detail recently on the JENNIE Show on the News
Channel ABC 6, WJBF in Augusta, GA. Also, one patient in this phase
1 study experienced an ongoing and durable partial response, and
this patient was recently featured in the Augusta Chronicle, as she
is being treated by Dr. Ghamande at the Georgia Cancer Center at
Augusta University. Read the full Augusta Chronicle
article here.
Overall, nine patients who had documented disease progression
after they had received curative treatments of chemotherapy and/or
radiation with or without bevacizumab were enrolled in this phase
1, open-label, dose-determining study. Axalimogene filolisbac was
well-tolerated across two dose levels. The study also established a
recommended phase 2 dose of 1×1010 CFU and demonstrated
antitumor activity at that dose. Axalimogene filolisbac was safely
administered at 5 and 10 times the dose levels previously studied,
without significant toxicity.
“The best overall tumor response in eight of the nine enrolled
patients is encouraging in evaluating the potential of axalimogene
filolisbac,” said Dr. Ghamande. “We were pleased to see a sustained
and durable partial response in one patient, which is very rare for
this kind of tumor that is unresponsive to chemotherapy, and
survival in these patients is often less than 10 months. In
addition, we could safely administer the drug at 5 and 10 times the
dose levels previously studied, without any significant
toxicity.”
There was only one instance of dose-limiting toxicity, with that
patient experiencing a grade 3 treatment related adverse event
(TRAE) of hypotension at a dose of 5×109 CFU. Across all
doses, eight of nine patients experienced a grade 1-2 TRAE,
including chills, nausea and hypotension.
The poster on the phase 1 data, “High-dose treatment with
ADXS11-001, a Listeria monocytogenes-listeriolysin O
(Lm-LLO) immunotherapy, in women with cervical cancer: a phase I,
dose-escalation study” (no. 58) is available
at www.advaxis.com. The company is preparing to initiate a
phase 3 trial in PRmCC later this year.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170515005671/en/
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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