Advaxis Announces FDA Lifts Clinical Hold on Phase 1/2 Combination Study of Axalimogene Filolisbac with Durvalumab
July 13 2018 - 8:00AM
Business Wire
Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology
company focused on the discovery, development and commercialization
of immunotherapy products, today announced that the U.S. Food and
Drug Administration (FDA) has lifted the clinical hold on the
Company’s Investigational New Drug (IND) application for its Phase
1/2 study of axalimogene filolisbac (AXAL) in combination with
durvalumab for the treatment of patients with advanced, recurrent
or refractory cervical cancer and HPV-associated head and neck
cancer.
The clinical hold for this study was issued on March 9, 2018
following submission by the Company of a safety report to the FDA
regarding a patient death that occurred on February 27, 2018,
post-dosing, involving acute respiratory failure after nine months
of combination therapy. New guidelines for the early detection and
treatment of such rare events were agreed to with the FDA and will
be implemented for this combination study. Enrollment and dosing in
all other Advaxis and durvalumab clinical programs were not
affected by the clinical hold.
“We are pleased to have resolved this issue with the FDA and
will implement these guidelines across Advaxis’ portfolio as
needed, to ensure patient safety. We remain confident in the safety
of axalimogene filolisbac based on our experience in treating
approximately 400 patients and more than 1200 doses across multiple
trials in HPV-associated cancers,” said Kenneth A. Berlin,
President and Chief Executive Officer of Advaxis.
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% in 50 patients. This is a 52% 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.
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 product candidates in various stages of clinical and
preclinical development in the following areas: HPV-associated
cancers, neoantigen therapy, hotspot/cancer antigens and prostate
cancer.
To learn more about Advaxis, visit www.advaxis.com and connect
on Twitter, LinkedIn, Facebook.
Advaxis Forward-Looking Statement
Some of the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. The factors that could
cause our actual results to differ materially include:
our ability to develop and commercialize the next generation of
cancer immunotherapies; the safety and efficacy of our proprietary
immunotherapies; the success and timing of our clinical trials,
including patient accrual; our ability to release the clinical hold
and reduce the impact to our trials; our ability to obtain and
maintain regulatory approval and/or reimbursement of our product
candidates for marketing; our plans to develop and commercialize
our products; our ability to successfully compete in the potential
markets for our product candidates, if commercialized; our ability
to obtain additional funding; the success and timing of our
preclinical studies including IND enabling studies; and our ability
to successfully implement our strategy. These forward-looking
statements are subject to a number of risks including the
forward-looking statements and risk factors set forth from time to
time in Advaxis’ SEC filings including, but not limited to, our
report on Form 10-K for the fiscal year ended October 31, 2017, and
on Form 10-Q for the quarter ended January 31, 2018, which are
available at www.sec.gov.
Any forward-looking statements set forth in
this press release 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: https://www.businesswire.com/news/home/20180713005040/en/
Investors:LHA Investor RelationsMiriam Weber Miller,
(212) 838-3777mmiller@lhai.comorAdvaxis, Inc.Ranya Dajani, (609)
250-7559Dajani@advaxis.com
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