Advaxis Announces Increasing Focus on Neoantigen-Directed Immunotherapies and Closing of Its Phase 3 AIM2CERV Study
June 27 2019 - 6:50AM
Business Wire
Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage
biotechnology company focused on the discovery, development and
commercialization of immunotherapy products, today announced that
it is increasing its focus on neoantigen-directed immunotherapies
and closing the AIM2CERV Phase 3 clinical trial with axalimogene
filolisbac (AXAL) in high-risk locally advanced cervical cancer.
Advaxis intends to continue to support the clinical development of
AXAL, its single-antigen construct, in other HPV-related cancers
while redirecting resources towards advancing its
neoantigen-directed programs. Specifically, the company plans to
continue developing ADXS-NEO, currently in a Phase 1 clinical
trial, in patients with several types of advanced or metastatic
solid tumors including melanoma, lung, colorectal, head and neck
and bladder cancers, and ADXS-HOT, currently in a Phase 1/2
clinical trial, for non-small cell lung cancer. The company
anticipates advancing additional drug constructs from its ADXS-HOT
program into the clinic over the next 18 months.
“We remain firmly committed to our Lm Technology™ platform,
including our personalized and off-the-shelf approaches for
neoantigen-directed therapies, and the development of AXAL against
HPV-related cancers,” said Kenneth A. Berlin, President and Chief
Executive Officer of Advaxis. “While closing the AIM2CERV trial was
a difficult decision due to the efforts of many individuals
including the investigators and patients, the delays we incurred as
a result of the recent FDA partial clinical hold and the estimated
cost and time to completion for AIM2CERV led us to believe the best
path forward for the company is to focus on our neoantigen
programs. We believe this increased focus will enable a quicker and
more cost-effective approach to demonstrate the strength and
versatility of our Lm platform, thereby enhancing shareholder
value.”
The estimated remaining cost to complete the AIM2CERV trial
ranges from $80 million to $90 million, and initial efficacy data
is not anticipated for at least three years. Therefore, results
from the clinical trial were not the basis for the decision to
close the study, nor was safety as the trial recently underwent its
third Independent Data Monitoring Committee (IDMC) review with no
safety issues noted. The company plans to unblind the AIM2CERV
clinical data generated to date and anticipates submitting these
data for publication. In addition, Advaxis will continue to pursue
monetization opportunities for AXAL.
“The emerging data from our neoantigen programs look very
promising, and therefore these programs merit an increased focus of
the company’s resources,” stated Mr. Berlin. “With this redirection
of resources to our neoantigen programs, we anticipate our cash
usage for the next 12 months will be in the range of $33 million to
$37 million, which includes $8 million to $9 million in
non-recurring costs associated with prior AXAL studies including
AIM2CERV. This reduction in our cash burn is a significant
improvement over the past several years and also betters the goal
we set of $45 million at the beginning of our fiscal year 2019.” He
concluded, “We believe these changes will enable us to pursue a
leadership position in the neoantigen field by building upon the
early and exciting data from our ADXS-NEO and ADXS-HOT
programs.”
About Advaxis, Inc.
Advaxis, Inc. is a clinical-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 development: ADXS-NEO, a
personalized neoantigen-directed therapy in principle for any solid
tumor; ADXS-503 for non-small cell lung cancer, from its ADXS-HOT
off-the-shelf neoantigen-directed program, ADXS-PSA for prostate
cancer and ADXS-HPV for HPV-associated cancers.
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 impact
of the discontinuation on relationships related to the AIM2CERV
Study; 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, including to support current and planned clinical activities;
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 our existing 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190627005184/en/
Investors: LHA Investor Relations Yvonne Briggs, (310) 691-7100
ybriggs@lhai.com
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