Advaxis Announces Enrollment of the First Patient in its Phase 1/2 Trial for ADXS-HOT in the Treatment of Non-Small Cell Lung Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Advaxis,
Inc.
 (NASDAQ:ADXS), a late-stage biotechnology company focused on
the discovery, development and commercialization of immunotherapy
products, announced it has initiated its Phase 1/2 clinical trial to
evaluate ADXS-503, part of the Company’s ADXS-HOT program, in the
treatment of non-small cell lung cancer (NSCLC) and has enrolled the
first patient in the trial. ADXS-HOT is a cancer-type specific
immunotherapy program which leverages Advaxis’ 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 under the ADXS-HOT program.

“Coming on the heels of the presentation of data from our immunotherapy
platform at the I/O 360 conference last week, we are excited to announce
the enrollment of the first ADXS-HOT patient in our Phase 1/2 trial
evaluating ADXS-503 for the treatment of NSCLC. The data presented at
I/O 360 suggest that our neoantigen-directed constructs from both our
ADXS-NEO and ADXS-HOT programs have the potential to demonstrate
best-in-class CD+8 T cell response for neoantigen therapies,” said
Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. He
continued, “We believe our ADXS-HOT drug constructs have significant
advantages compared to certain other neoantigen-focused therapies in
development as our ADXS-HOT drug constructs are off-the-shelf and
immediately available to administer to the patient and have a favorable
cost to manufacture.” He concluded, “The ADXS-HOT program supports our
goal of leveraging the significant experience we have gained from our
proprietary platform in order to advance programs in the fight against
cancer for patients in need of new therapeutic options and we look
forward to studying these constructs in the clinic.”

The Phase 1/2 clinical trial for ADXS-503 will seek to establish the
recommended dose, safety, tolerability and clinical activity of ADXS-503
administered alone (initially) and in combination with a checkpoint
inhibitor in approximately 50 patients with NSCLC in different lines of
therapy, at up to 20 centers across the U.S. Advaxis anticipates initial
data from the first cohort of ADXS-503 in the first half of 2019.

About ADXS-HOT

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
proprietary cancer-testes and oncofetal tumor-associated antigens that
also commonly occur in specific cancer types. ADXS-HOT drug candidates
are an off-the-shelf treatment, designed to potentially treat all
patients with a specific cancer type, without the need for pretreatment
biomarker testing, DNA sequencing or diagnostic testing.

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 programs 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 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; 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 to resolve FDA’s partial
clinical hold, the 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]

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