Advaxis Granted U.S. Patent Relating to Axalimogene Filolisbac

Currently in a Phase 3 Pivotal Study for High-Risk Locally Advanced
Cervical Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Advaxis,
Inc. (NASDAQ: ADXS) (the Company), a late-stage
biotechnology company focused on the discovery, development and
commercialization of immunotherapy products, announces that the U.S.
Patent and Trademark Office has granted patent number 10,189,885 titled “Non-Hemolytic
LLO Fusion Proteins and Methods of Utilizing Same.” This
composition-of-matter patent extends protection for axalimogene
filolisbac (AXAL) through March 2028.

“We are pleased to receive another patent to further expand our robust
intellectual property portfolio of more than 400 issued or pending
patents worldwide,” said Robert G. Petit, Ph.D., Chief Scientific
Officer of Advaxis. “The issuance of this patent provides additional
intellectual property protection for AXAL, which has demonstrated
clinical activity across multiple tumor types.”

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. The U.S. Food and Drug Administration (FDA or Agency) has
granted AXAL Fast Track designation for adjuvant therapy for high-risk
locally advanced cervical cancer, and a Special Protocol Assessment
(SPA) for the Phase 3 AIM2CERV trial evaluating its potential to delay
or prevent the recurrence of locally advanced cervical cancer. The FDA
has also granted AXAL orphan drug designation in three clinical
indications.

Advaxis is in discussions with FDA regarding the partial clinical hold
on its Phase 3 AIM2CERV trial and is working to address the questions
raised by the Agency surrounding prior AXAL chemistry, manufacturing and
controls matters. The FDA did not cite any safety issues related to the
trial and all currently enrolled patients are continuing to receive
treatment, although no new patients are being enrolled. Advaxis is also
in dialogue with FDA to request an amendment to the SPA to include an
earlier interim analysis for efficacy.

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 (AXAL) 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 and to resolve FDA’s partial clinical hold; 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; 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
Miriam Weber Miller, (212)
838-3777
[email protected]