Advaxis and Merck Form Collaboration to Evaluate Investigational Combination
of Two Novel Immunotherapy Candidates for Advanced Prostate Cancer
PRINCETON, N.J., Aug. 25, 2014 (GLOBE NEWSWIRE) -- Advaxis,
Inc.(Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer
immunotherapies, has entered into a clinical trial collaboration agreement
with Merck, known as MSD outside the United States and Canada, through its
subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer
immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1 antibody,
pembrolizumab. The planned clinical trial will evaluate the safety and
efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a
Phase 1/2 study of patients with previously treated metastatic,
castration-resistant prostate cancer.
Both ADXS-PSA and pembrolizumab are investigational members of a new class of
cancer treatments known as immunotherapies that are designed to enhance the
body's own defenses in fighting cancer. Preclinical evidence suggests that
Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead
to an enhanced anti-tumor immune response.
"We are excited to be working with Merck. Equally as exciting is the
combination potential of our Lm-LLO immunotherapy with Merck's anti-PD-1
immune checkpoint inhibitor," commented Daniel J. O'Connor, President and
Chief Executive Officer of Advaxis. "We believe the combination of Advaxis
Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant
promise for the treatment of prostate and other cancers."
Under the terms of the agreement, Advaxis and Merck will collaborate to
evaluate the ADXS-PSA/pembrolizumab combination as a treatment for prostate
cancer. The Phase 1 part of the trial is designed to establish a recommended
dose regimen for ADXS-PSA alone and combined with pembrolizumab, and the Phase
2 portion will assess the safety and efficacy of the combination. Advaxis will
sponsor and fund the study and Merck will provide pembrolizumab. The companies
will collaboratively oversee the conduct of the study, which is planned to
begin in early 2015. Results from the study will be used to determine the path
for further clinical development of the combination.
"Collaborations such as this are an integral part of Merck's strategy to
evaluate the potential of pembrolizumab in multiple combinations for a broad
range of cancers," said Dr. Eric Rubin, vice president Oncology, Merck
Research Laboratories."We look forward to working with Advaxis to evaluate
this novel investigational combination immunotherapy for the treatment of
advanced prostate cancer."
About Prostate Cancer
According to the American Cancer Society, prostate cancer is the most common
type of cancer found in American men, other than skin cancer. Prostate cancer
is the second leading cause of cancer death in men, behind only lung cancer.
One man in six will get prostate cancer during his lifetime, and one man in 36
will die of this disease.
ADXS-PSA is an Lm-LLO immunotherapy that is designed to target the PSA antigen
associated with prostate cancer. ADXS-PSA secretes the PSA antigen, fused to
the powerful immunostimulant tLLO, directly inside the antigen presenting
cells that are capable of driving a cellular immune response to PSA expressing
cells. The Advaxis approach is also designed to inhibit the Treg and MDSC
cells that contribute to immunologic tolerance of prostate cancer. In
preclinical analysis, ADXS-PSA inhibits the immunosuppression caused by Treg
and MDSC cells localized inside tumors that we believe promotes immunologic
tolerance of prostate cancer.
Pembrolizumab (MK-3475) is an investigational, humanized, monoclonal antibody
against PD-1 designed to reactivate anti-tumor immunity. Pembrolizumab exerts
dual ligand blockade of the PD-1 pathway by inhibiting the interaction of PD-1
on T cells with its ligands PD-L1 and PD-L2.
Pembrolizumab is currently being evaluated across more than 30 types of
cancers, as monotherapy and in combination. It is anticipated that by the end
of 2014, the pembrolizumab development program will grow to more than 24
clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical
trial sites worldwide. For information about Merck's oncology clinical
studies, please visithttp://www.merck.com/clinical-trials/index.html.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing multiple cancer
immunotherapies based on its proprietary platform intended to redirect the
immune system to kill cancer. The Advaxis Lm-LLO technology, using
bioengineered live attenuated Listeria monocytogenes bacteria, is the only
known cancer immunotherapy agent shown in preclinical studies to both generate
cancer fighting T-cells directed against a cancer antigen and neutralize Tregs
and MSDCs, that protect the tumor microenvironment from immunologic attack and
contribute to tumor growth. Advaxis's lead immunotherapy, ADXS-HPV, targets
human papillomavirus (HPV)-associated cancers and is in clinical trials for
three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and
neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan
drug designation for each of these three indications. The Company plans to
initiate a registrational clinical program for cervical cancer in 2014 and has
established licensing partners in India and Asia for commercialization in
those regions. Advaxis is planning to evaluate the combination of ADXS-HPV
with an anti-PD-L1 immune checkpoint inhibitor in HPV-associated cancers.
Advaxis's second immunotherapy candidate in clinical testing will be ADXS-PSA,
which is being developed to address prostate cancer. Advaxis is planning to
file an IND with the FDA and initiate a Phase 1-2 clinical study with
ADXS-PSA. Advaxis is also developing ADXS-cHER2, to target the Her2 receptor
overexpressing cancers.Her2 is overexpressed in certain solid-tumor cancers,
including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal,
and gastric cancer. Advaxis is developing ADXS-cHER2 for both human and
animal-health, and has seen promising results in canine osteosarcoma, which is
considered a model for human osteosarcoma. Advaxis is pursuing a clinical
program in pediatric osteosarcoma and has licensed ADXS-cHER2 and three other
immunotherapy constructs to a major animal-health company. Advaxis is planning
to file an IND for ADXS-cHER2 in Her2 overexpressing cancers.
For more information please visit www.advaxis.com or connect with us on
This news release contains forward-looking statements, including, but not
limited to: statements regarding Advaxis's ability to develop the next
generation of cancer immunotherapies; the safety and efficacy of Advaxis's
proprietary immunotherapy, ADXS HPV; whether Advaxis immunotherapies can
redirect the powerful immune response all human beings have to the bacterium
to cancers. These forward-looking statements are subject to a number of risks,
including the risk factors set forth from time to time in Advaxis's SEC
filings, including but not limited to its report on Form 10-K for the fiscal
year ended October 31, 2013, which is available at http://www.sec.gov. Advaxis
undertakes no obligation to publicly release the result of any revision to
these forward-looking statements, which may be made to reflect the events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events, except as required by law. You are cautioned not to
place undue reliance on any forward-looking statements.
CONTACT: Advaxis Contact:
Senior Director of Investor Relations and
Tiberend Strategic Advisors, Inc.
Amy S. Wheeler
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