FDA Lifts Partial Clinical Hold on Phase 3 AIM2CERV Study of Axalimogene Filolisbac

PRINCETON, N.J.–(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 or Agency) has lifted the partial clinical hold on
AIM2CERV, the company’s Phase 3 clinical trial of axalimogene filolisbac
(AXAL) for the treatment of patients with high-risk locally advanced
cervical cancer. In its letter, the FDA acknowledged that the company
satisfactorily addressed all hold questions.

As announced on January 23, 2019, the FDA placed a partial clinical hold
on this study relating to the Agency’s requests for additional
information pertaining to certain AXAL chemistry, manufacturing and
controls (CMC) matters. The Agency did not cite any safety issues
related to the trial and all enrolled patients continued to receive
treatment, per the trial protocol. However, no new patients were
permitted to enroll in AIM2CERV during this partial hold.

“The Advaxis team worked diligently to provide a comprehensive response
back to the FDA’s requests for additional CMC information, and through
constructive dialogue, we successfully resolved the partial clinical
hold,” said Kenneth A. Berlin, President and Chief Executive Officer of
Advaxis. “Our AXAL product has demonstrated a manageable safety profile
in the over 400 patients we have dosed to date, and we look forward to
working with our clinical research organization to reopen enrollment at
AIM2CERV sites. We remain focused on our mission of developing
innovative therapies to address unmet needs and improving the lives of
people with cancer.”

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 T cells to eliminate
tumors. Advaxis has four programs in various stages of clinical
development: ADXS-HPV for cervical cancer; ADXS-NEO, a personalized
neoantigen-directed therapy for multiple cancers; ADXS-503 for non-small
cell lung cancer, from its ADXS-HOT off-the-shelf neoantigen-directed
program; and ADXS-PSA for prostate cancer.

To learn more about Advaxis, visit www.advaxis.com
and connect on Twitter, LinkedIn, Facebook and YouTube.

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: the success and timing
of our clinical trials, including subject accrual; our ability to avoid
any clinical holds; our ability to obtain and maintain regulatory
approval and/or reimbursement of our product candidates for marketing;
our ability to obtain the appropriate labeling of our products under any
regulatory approval; our plans to develop and commercialize our
products; the successful development and implementation of our sales and
marketing campaigns; the size and growth of the potential markets for
our product candidates and our ability to serve those markets; our
ability to successfully compete in the potential markets for our product
candidates, if commercialized; regulatory developments in the United
States and other countries; the rate and degree of market acceptance of
any of our product candidates; new products, product candidates or new
uses for existing products or technologies introduced or announced by
our competitors and the timing of these introductions or announcements;
market conditions in the pharmaceutical and biotechnology sectors; our
available cash, including to support current and planned clinical
activities; the accuracy of our estimates regarding expenses, future
revenues, capital requirements and needs for additional financing; our
ability to obtain additional funding; our ability to obtain and maintain
intellectual property protection for our product candidates; the success
and timing of our preclinical studies including IND-enabling studies;
the timing of our IND submissions; our ability to get FDA approval for
study amendments; the timing of data read-outs; the ability of our
product candidates to successfully perform in clinical trials; our
ability to initiate, enroll, and execute pilots and clinical trials; our
ability to maintain collaborations; our ability to manufacture and the
performance of third-party manufacturers; the performance of our
clinical research organizations, clinical trial sponsors and clinical
trial investigators; our ability to successfully implement our strategy;
and, other risk factors identified from time to time in our reports
filed with the SEC. 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.

Contacts

Investors:
LHA Investor Relations
Yvonne Briggs, (310) 691-7100
[email protected]