Advaxis Announces Two Poster Presentations at the Frontiers in Cancer Immunotherapy Conference

• Updated data from Phase 1/2 ADXS-PSA study combination arm show
  prolonged survival in heavily pretreated prostate cancer patients with
  microsatellite-stable (MSS) disease
• Updated early findings from Phase 1 ADXS-NEO study show encouraging
  safety, immunogenicity and clinical signals in MSS colorectal cancer
  patients

PRINCETON, N.J.–(BUSINESS WIRE)–Advaxis,
Inc. (NASDAQ: ADXS), a late-stage biotechnology company
focused on the discovery, development and commercialization of
immunotherapy products, announces the presentation of two posters at the
Frontiers in Cancer Immunotherapy conference, being held today at the
New York Academy of Sciences in New York City. Both posters were first
presented at the recent American Association for Cancer Research (AACR)
Annual Meeting, and each has updated findings being presented today.

The first presentation regarding a poster entitled “Effects of
ADXS-PSA With or Without Pembrolizumab on Survival and Antigen Spreading
in Metastatic, Castration-Resistant Prostate Cancer Patients (Results
from KEYNOTE-046)” is conference poster #31, and will be
presented by Robert Petit, Ph.D., Advaxis Chief Scientific Officer, and
Mark N. Stein, M.D., FACS, Associate Professor of Medical Oncology at
Columbia University Medical Center, from 4:45 to 5:30 p.m. Eastern time.

The Phase 1/2 KEYNOTE-046 study is being conducted in conjunction with
Merck (known as MSD outside the U.S. and Canada) in metastatic,
castration-resistant prostate cancer (mCRPC). This trial and is
evaluating ADXS-PSA, one of Advaxis’ Listeria monocytogenes (Lm)-based
immunotherapies, alone and in combination with KEYTRUDA^® (pembrolizumab),
Merck’s anti-PD-1 therapy.

KEYNOTE-046 is an open-label, multicenter, dose-determining safety and
tolerability Phase 1/2 trial of 50 heavily pretreated patients conducted
in two parts (Part A and Part B), with a Phase 2 expansion cohort. The
objective of the study is to evaluate ADXS-PSA alone (Part A) and in
combination with KEYTRUDA^® (Part B) for primary endpoints
that include safety, tolerability and dosing. Secondary endpoints
include anti-tumor activity and progression-free survival, and
exploratory endpoints include associations between biomarkers of
immunologic response (serum PSA) with clinical outcomes.

Key findings from 37 patients treated in the combination arm (Part B) of
KEYNOTE-046 as reported at AACR include the following:

• The majority of treatment-related adverse events consisted of
  transient and reversible Grade 1-2 chills/rigors, fever, hypotension,
  nausea and fatigue. The combination of ADXS-PSA and pembrolizumab has
  been well-tolerated to date, with no additive toxicity observed.
• Median overall survival (OS) was 21.1 months at data cutoff (February
  1, 2019) (95% CI, range 16.0 months to not-yet-reached) in this
  dataset of 37 patients.
• Correlative immune analyses showed T-cell responses against PSA in 75%
  of subjects and antigen spreading in 85% of subjects.
• Broader immune stimulation, including B-cell activation, was observed
  in the combination arm (n=37) than in the ADXS-PSA monotherapy arm
  (n=13).

Updated findings being presented at the Frontiers in Cancer
Immunotherapy conference include:

• Microsatellite Instability-High (MSI-High), the condition of genetic
  hypermutability that results from defective DNA mismatch repair, is
  observed in 5-12% of all mCRPC patients and often leads to a higher
  likelihood of response to immunotherapy. In this study, 36 of the
  patients in the combination arm, which observed prolonged survival,
  were MSI-High negative (with one subject not tested), thereby making
  them unlikely to respond to checkpoint blockade.
• There are 16 patients in the combination therapy part of this trial
  who are alive and continue to be monitored.

“The latest results from our KEYNOTE-046 study demonstrate that
practically all the patients in the combination arm of this study are
microsatellite stable and therefore are not expected to respond to
treatment with a checkpoint inhibitor,” said Kenneth A. Berlin,
President and Chief Executive Officer of Advaxis. “These data suggest
that the combination of ADXS-PSA and pembrolizumab appears to show
activity and to be associated with prolonged OS in this population.”

The second poster discussion entitled “Safety and Immunogenicity of a
Personalized Neoantigen-Listeria Vaccine in Cancer Patients” is
conference poster #9, and will be presented by Frank Tsai, M.D.,
Medical Oncologist and Investigator at Honor Health Research Institute
and one of the lead investigators of the ADXS-NEO clinical study, from
4:45 to 5:30 p.m. Eastern time.

ADXS-NEO is a live, attenuated Lm immunotherapy 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 as reported at AACR
include the following:

• 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.

Updated findings being presented at the Frontiers in Cancer
Immunotherapy conference include:

• Data from the two MSS colorectal cancer patients dosed with
  ADXS-NEO at 1×10⁸ CFU demonstrated increased CD8+ T
  cell infiltration in the tumor microenvironment after three doses of
  ADXS-NEO. Both patients had metastatic colorectal cancer, which is
  considered to be a “cold” tumor and typically exhibits little CD8+ T
  cell infiltration and resistance to immunotherapy, yet both
  successfully transitioned from “cold” tumors into “hot” tumors with
  ADXS-NEO therapy. An estimated 80-85% of colorectal cancer patients
  are MSS.
• Two patients (one treated at 1×10⁹ and one at 1×10⁸
  CFU) achieved stable disease per RECIST 1.1 criteria. Another patient
  has yet to be evaluated but has experienced normal performance status
  and an active lifestyle over the three months of therapy with ADXS-NEO
  at 1×10⁸ CFU.

“Although we have just started to define the safety, immunogenicity and
changes in the tumor microenvironment with ADXS-NEO monotherapy, it is
possible that these effects may have a positive impact in the
sensitivity to checkpoint inhibitors in ‘cold’ tumors,” said Dr. Tsai.
“We look forward to further documenting the effects of ADXS-NEO
monotherapy in MSS metastatic colorectal cancer (CRC) and in other
tumors. Also, since the majority of patients with MSS-CRC do not respond
well to immunotherapy, we are also looking forward to starting the
combination therapy of ADXS-NEO and a checkpoint inhibitor, as called
for in the current study.”

Mr. Berlin added, “We are pleased to report encouraging updated findings
from both of these ongoing studies at the Frontiers in Cancer
Immunotherapy conference. We are encouraged given that we are seeing
clinical benefit from our immunotherapy drug candidates in
difficult-to-treat patient populations in furtherance of our mission to
helping improve the lives of people with cancer. We look forward to
sharing further data from our programs throughout the balance of the
year.”

Both posters will be available at www.advaxis.com
today at 4:45 p.m. ET.

About KEYNOTE-046

KEYNOTE-046 (NCT02325557) is a Phase 1/2 open-label, multicenter,
dose-determination and expansion trial that evaluates the safety,
tolerability and preliminary clinical activity of ADXS-PSA as
monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA^®
(Part B; n=37) in heavily pretreated patients with progressive and
refractory mCRPC.

About ADXS-PSA

ADXS-PSA, one of Advaxis’ Lm-based immunotherapies, utilizes
live, attenuated, bioengineered Lm as a vector to deliver PSA
directly to antigen presenting cells. Development is being pursued in a
clinical trial collaboration and supply agreement with Merck.

About ADXS-NEO

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 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.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

Contacts

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