Preliminary Data from Phase 1 Study Evaluating ADXS-NEO Suggest Rapid Immunogenicity and Clinical Activity

March 29, 2019 Off By BusinessWire

Data to be Presented at AACR Annual Meeting

 (NASDAQ: ADXS), a late-stage biotechnology company
focused on the discovery, development and commercialization of
immunotherapy products, announces the presentation of ADXS-NEO data in a
poster discussion entitled “Safety and Immunogenicity of a
Personalized Neoantigen-Listeria Vaccine in Cancer Patients”
at the
American Association for Cancer Research (AACR) Annual Meeting underway
in Atlanta. The discussion will be held on Sunday, March 31, 2019 from
1:00-5:00 p.m. ET and will be led by J. Randolph Hecht, M.D., Professor
of Clinical Medicine, David Geffen School of Medicine at UCLA and
Director of the UCLA Gastrointestinal Oncology Program.

ADXS-NEO is a live, attenuated Listeria monocytogenes (Lm)
using personalized antigen delivery based on
whole-exome sequencing of a patient’s tumor to identify personal
neoantigens. The ongoing Phase 1 trial is designed to evaluate the
safety, tolerability and preliminary clinical immunological activity of
ADXS-NEO alone (Part A) and in combination with anti-PD-1 antibody
therapy (Part B) in subjects with certain types of advanced or
metastatic solid tumors. Part C of the trial will be an expansion of the
combination therapy arm and will be initiated based on emerging data
from the first two parts of the trial.

Preliminary findings from the ADXS-NEO Phase 1 study include the

  • Substantial anti-tumor immunity, including T cell responses to
    neoantigens and antigen spreading, was observed within one week of
    first dose at both dose levels
  • Dosing of ADXS-NEO at 1×108 colony forming units
    (CFU) has been well-tolerated in two patients
  • ADXS-NEO dosed at 1×109 CFU was beyond the maximum
    tolerated dose (MTD)

    • Reversible Grade 3 hypoxia (n=2) and Grade 3 hypotension (n=1)
      were dose-limiting toxicities (DLTs)
  • Manufacturing of ADXS-NEO, comprised of 40 personal neoantigens, was
    successfully completed within seven to eight weeks for each subject

“Advaxis’ ADXS-NEO is a novel, personalized vaccine encoding mutations
specific to an individual patient’s tumor designed to induce anti-cancer
immunity. Four patients have been evaluated across two dose levels thus
far in this ongoing clinical trial. While dose level 1 (1×109
CFU) was determined to be above the MTD, dose level -1a (1×108
CFU) has been safe and well tolerated in two patients treated to date,
with primarily Grade 1 and Grade 2 chills, fever and tachycardia.
Substantial immunological activity was observed across both dose levels,
including rapid neoantigen-specific CD8+ T cell generation, which is
essential for potential clinical benefit. We look forward to the planned
combination therapy arm with checkpoint inhibitors,” said Dr. Hecht.

“The patients being evaluated for safety and tolerability in Part A all
have late-stage disease and have been treated with numerous prior
therapies. As a result, we did not expect to observe significant
clinical activity in this cohort,” said Andres Gutierrez, M.D. Ph.D.,
Chief Medical Officer of Advaxis. “Nevertheless, we have seen some
encouraging clinical signals to date, including one patient at dose
level 1 with non-small cell lung cancer who achieved stable disease
after only two doses of ADXS-NEO, which is consistent with rapid immune
activation.” He concluded, “This is the first presentation of clinical
data from our ADXS-NEO program at a major medical conference. We are
continuing to enroll subjects and gather additional clinical and immune
correlative data, and plan to share updated data from this study
throughout this year.”

The full abstract is available at
and the poster will be available on the Company’s website on Sunday,
March 31, 2019 at 1:00 p.m. ET.


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 tumor. The program focuses on creating a
customized treatment for each patient targeting multiple neoantigens
found in a biopsy of the patient’s tumor.

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
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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 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.


LHA Investor Relations
Miriam Weber Miller, (212)
[email protected]