FDA Lifts Partial Clinical Hold on Phase 3 AIM2CERV Study of Axalimogene Filolisbac
May 15 2019 - 8:00AM
Business Wire
Advaxis, Inc. (NASDAQ: ADXS), a late-stage
biotechnology company focused on the discovery, development and
commercialization of immunotherapy products, today announced that
the U.S. Food and Drug Administration (FDA or Agency) has lifted
the partial clinical hold on AIM2CERV, the company’s Phase 3
clinical trial of axalimogene filolisbac (AXAL) for the treatment
of patients with high-risk locally advanced cervical cancer. In its
letter, the FDA acknowledged that the company
satisfactorily addressed all hold questions.
As announced on January 23, 2019, the FDA placed a partial
clinical hold on this study relating to the Agency’s requests for
additional information pertaining to certain AXAL chemistry,
manufacturing and controls (CMC) matters. The Agency did not
cite any safety issues related to the trial and all enrolled
patients continued to receive treatment, per the trial protocol.
However, no new patients were permitted to enroll in AIM2CERV
during this partial hold.
“The Advaxis team worked diligently to provide a comprehensive
response back to the FDA’s requests for additional CMC information,
and through constructive dialogue, we successfully resolved the
partial clinical hold,” said Kenneth A. Berlin, President and Chief
Executive Officer of Advaxis. “Our AXAL product has demonstrated a
manageable safety profile in the over 400 patients we have dosed to
date, and we look forward to working with our clinical research
organization to reopen enrollment at AIM2CERV sites. We remain
focused on our mission of developing innovative therapies to
address unmet needs and improving the lives of people with
cancer.”
About Axalimogene Filolisbac
Axalimogene filolisbac is a targeted Listeria monocytogenes
(Lm)-based immunotherapy that attacks HPV-associated cancers by
altering a live strain of Lm bacteria to generate
cancer-fighting T cells against cancer antigens while neutralizing
the tumor’s natural protections that guard the tumor
microenvironment from immunologic attack. In a Phase 2 trial
evaluating axalimogene filolisbac for the treatment of persistent
or recurrent metastatic (squamous or non-squamous cell) carcinoma
of the cervix (PRmCC), the drug candidate showed a 12-month overall
survival rate of 38% in 50 patients. This is a 52% improvement over
the 12-month overall survival rate that was expected in the trial’s
patient population based on prognostic factors.
Axalimogene filolisbac has received Fast Track designation for
adjuvant therapy for high-risk locally advanced cervical cancer
(HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV
trial in HRLACC patients. The immunotherapy has also received
orphan drug designation in three clinical indications.
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; 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 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/20190515005119/en/
Investors:LHA Investor RelationsYvonne Briggs, (310)
691-7100ybriggs@lhai.com
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