Market Overview

Advaxis Announces FDA Allowance of IND Application for ADXS-HOT Drug Candidate for Non-Small Cell Lung Cancer


Selects Bladder Cancer as Third ADXS-HOT Drug Candidate to Take
into the Clinic after Non-Small Cell Lung and Prostate Cancers

Advances Goal to Have Five Neoantigen-Based Drug Candidates in
Clinical Evaluation by 4Q 2019

 (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 allowed the Company's IND application for its ADXS-HOT drug
candidate for non-small cell lung cancer (NSCLC). Advaxis anticipates
that because of this timely allowance, the first patient in the Phase
1/2 trial for this NSCLC drug candidate will be dosed by the end of 2018.

ADXS-HOT is a cancer-type specific immunotherapy approach that leverages
the Company's proprietary Lm technology platform to target
hotspot mutations that commonly occur in specific cancer types as well
as other proprietary tumor-associated antigens. To date, more than 10
drug candidates have been designed for different tumor types in the
ADXS-HOT program.

"This is an exciting time for Advaxis as we prepare to initiate the
first clinical trial with a drug candidate from our ADXS-HOT program.
This drug candidate, ADXS-503, has been designed for the treatment of
patients with NSCLC," said Kenneth A. Berlin, President and Chief
Executive Officer of Advaxis. "With our increased strategic focus on
neoantigen-based therapeutics, including the personalized,
patient-specific approach of our ADXS-NEO program, already in a clinical
trial, we anticipate having five neoantigen-based drug candidates in
clinical evaluation by the end of 2019. Our next two ADXS-HOT drug
candidates will focus on prostate and bladder cancers. These two tumor
types, along with NSCLC, were prioritized based on our evaluation of a
number of factors relating to each, including the unmet medical need,
time and investment required to demonstrate meaningful clinical activity
and immunological sensitivity," concluded Mr. Berlin.

The Company plans to initiate a Phase 1/2 clinical trial that will seek
to establish the safety, tolerability and effectiveness of ADXS-503
administered alone and in combination with a checkpoint inhibitor in
approximately 50 patients with metastatic NSCLC in different lines of
therapy, at up to 20 centers across the U.S.

"I am pleased we can move forward to advance our first trial with
ADXS-503, the first drug candidate in our ADXS-HOT program. This is an
important clinical milestone as we seek to demonstrate proof-of-concept
for ADXS-HOT immunotherapy in NSCLC, where there remains significant
unmet need despite the introduction of checkpoint inhibitors and
targeted therapies," said Andres Gutierrez, M.D., Ph.D., Chief Medical
Officer and Executive Vice President of Advaxis. "Earlier drug
candidates from our Lm platform expressing a single antigen have
shown a favorable safety profile and preliminary clinical activity in
more than 500 subjects treated to date across different tumor types.
This clinical experience with prior Lm drug candidates, combined
with our ability to leverage the large capacity of our Lm vector
to express multiple neoantigens and other tumor-associated antigens,
provides the foundation for our belief that ADXS-HOT drug candidates
such as ADXS-503 for NSCLC can provide a new standard for off-the-shelf
neoantigen vaccines."

Advaxis affirms plans to submit a total of four INDs for drug candidates
from its ADXS-HOT program by the fourth quarter of 2019. Beyond NSCLC,
prostate cancer and bladder cancer, the fourth ADXS-HOT drug candidate
will be selected from breast, colorectal, ovarian or head and neck


ADXS-HOT is a program that leverages the Company's proprietary Lm
technology to target hotspot mutations that commonly occur in specific
cancer types. ADXS-HOT drug candidates are designed to target acquired
shared or "public" mutations in tumor driver genes along with other
cancer-testes and oncofetal tumor-associated antigens that also commonly
occur in specific cancer types. Although ADXS-HOT drug candidates have
not yet been tested in patients, they are an off-the-shelf treatment
approach been designed to potentially treat all patients with a specific
cancer type, without the need for pretreatment biomarker testing,
biopsy, DNA sequencing or diagnostic testing.


ADXS-NEO is an investigational personalized Lm-based
immunotherapy designed to generate immune response against
mutation-derived tumor-specific neoantigens identified through DNA
sequencing of a patient's own tumors. The program focuses on creating a
customized treatment for each patient targeting multiple neoantigens
found in a biopsy of the patient's tumor. ADXS-NEO is being developed in
partnership with Amgen.

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 four franchises in various stages of
clinical and preclinical development: HPV-associated cancers, neoantigen
therapy, hotspot/ cancer antigens and prostate cancer.

To learn more about Advaxis, visit
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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 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 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, the ability of our product candidates to
successfully perform in clinical trials; our ability to execute clinical
trials; our ability to maintain collaborations; our ability to initiate
pilot studies and clinical trials, enroll our trials, obtain and
maintain approval of our product candidates; 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.

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