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ADXS-PSA in Combination with KEYTRUDA® Prolonged Survival in Metastatic Castration-Resistant Prostate Cancer

April 1, 2019 Off By BusinessWire

Updated Results from Phase 1/2 Study to be Presented Today at the
AACR Annual Meeting

PRINCETON, N.J.–(BUSINESS WIRE)–Advaxis,
Inc. (NASDAQ: ADXS), a late-stage biotechnology company
focused on the discovery, development and commercialization of
immunotherapy products, today announced updated data from the Phase 1/2
KEYNOTE-046 study in metastatic, castration-resistant prostate cancer
(mCRPC). This trial is being conducted in conjunction with Merck (known
as MSD outside the U.S. and Canada) 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.

Findings will be highlighted in a poster discussion entitled “Effects
of ADXS-PSA with or without Pembrolizumab on Survival and Antigen
Spreading in Metastatic, Castration-Resistant Prostate Cancer Patients” at
the American Association for Cancer Research (AACR) Annual Meeting
underway in Atlanta. The poster discussion will be held today from
1:00-5:00 p.m. ET and will be led by lead author Mark N. Stein M.D.,
FACS, Associate Professor of Medical Oncology at Columbia University
Medical Center.

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.

“There is a pressing need to improve the care and treatment of patients
with metastatic, castration-resistant prostate cancer,” said Dr. Stein.
“Data from 37 patients in the combination arm of KEYNOTE-046 are
promising as a median overall survival of 21.1 months was observed.
These results compare favorably to standard-of-care therapy and to study
results from similar unselected patient populations with
bone-predominant disease, which indicates that this combination warrants
further investigation.”

Key findings from the combination arm of KEYNOTE-046 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 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).

“We are very excited to report the updated ADXS-PSA data today at the
AACR meeting,” said Kenneth A. Berlin, President and Chief Executive
Officer of Advaxis. “These data show the clinical potential of ADXS-PSA
both alone and in combination with KEYTRUDA^®. It is
meaningful that the combination has been well-tolerated in the study
population because dose-related toxicities can present challenges for
cancer patients, and an additive therapy with a favorable safety and
tolerability profile may offer an attractive option for clinicians if
developed further in this indication.” He concluded, “Based on the
prolonged survival data and strong safety profile to date, we believe
that continued clinical development of ADXS-PSA in combination with
KEYTRUDA^®is warranted and represents a potentially
significant opportunity for Advaxis.”

The full abstract is available at www.advaxis.com
and the poster will be available on the Company’s website today at 1:00
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 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.