Advaxis Announces FDA Lifts Clinical Hold on Phase 1/2 Combination Study of Axalimogene Filolisbac with Durvalumab

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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