Advaxis, Inc. (OTCQB: ADXS) (“Advaxis” or the “Company”), a leader in
developing the next generation of immunotherapies for cancer and
infectious diseases, announced the publication of preclinical
research with ADXS-HPV, Advaxis’ Lm-LLO lead drug candidate, for
the treatment of HPV-associated cancers in combination with PD-1
antibody.
The research was conducted by Dr. Samir N. Khleif and his research team
at the Georgia Regents University Cancer Center. Advaxis provided the Lm-LLO
immunotherapies and partial research funding. The paper titled
“Anti-PD-1 antibody significantly increases therapeutic efficacy of Listeria
monocytogenes (Lm)-LLO immunotherapy” by Drs. Mkrtichyan,
Chong, Eid, Wallecha, Singh, Rothman, and Khleif, has been e-published
in the Journal for Immunotherapy of Cancer.
The studies demonstrated that treatment with an Lm-LLO
immunotherapy, in combination with an anti-PD-1 antibody, significantly
improved immune and therapeutic efficacy in preclinical mouse models. In
addition, the study showed that a significant reduction of regulatory T
cells (Treg) and myeloid-derived suppressor cells (MDSC) in both the
spleen and the tumor microenvironment were mediated solely by the Lm-LLO
immunotherapy. The addition of anti-PD-1 antibody to the Lm-LLO
immunotherapy treatment resulted in a significant increase in
antigen-specific immune responses in the periphery and in CD8 T cell
infiltration into the tumor. As a result, this treatment combination led
to significant inhibition of tumor growth and prolonged
survival/complete regression of tumors in treated animals.
Given the findings in the mouse model, additional studies were conducted
to evaluate activity in human cells. In separate studies, Lm-LLO
immunotherapy treatment was found to significantly upregulate surface
PD-L1 expression on human monocyte-derived dendritic cells isolated from
healthy volunteers. This finding suggests that the combination of Lm-LLO
immunotherapy with an anti-PD-1 antibody could have clinical application.
“Previous studies with Lm-LLO immunotherapies have established
the ability to combine with chemotherapy and radiation. Dr. Khleif’s
data are first to show the potential of combining Advaxis constructs
with promising immune modulator (PD-1) in active clinical development,”
commented Dr. Petit.
The provisional
publication is available online.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next
generation of immunotherapies for cancer and infectious diseases.
Advaxis immunotherapies are based on a novel platform technology using
live, attenuated bacteria that are bio-engineered to secrete an
antigen/adjuvant fusion protein(s) that is designed to redirect the
powerful immune response all human beings have to the bacterium to
the cancer itself.
ADXS-HPV is currently being evaluated in four clinical trials for human
papillomavirus (HPV)-associated cancers: recurrent/refractory cervical
cancer (India), locally advanced cervical cancer (GOG/NCI U.S. study,
Clinical Trials.gov Identifier NCT01266460), head & neck cancer
(CRUK study, Clinical Trials.gov Identifier NCT01598792), and anal
cancer (BrUOG study, Clinical Trials.gov Identifier NCT01671488).
Advaxis has over 15 distinct immunotherapies in various stages of
development, developed directly by Advaxis and through strategic
collaborations with recognized centers of excellence such as: the National
Cancer Institute, Cancer
Research – UK, the University
of Pennsylvania, the Georgia
Regents University Cancer Center, the Karolinska
Institutet, and others.
For more information please visit: www.advaxis.com
Forward-Looking Statements
This news release contains forward-looking statements, including,
but not limited to: statements regarding the potential clinical
application of combining Lm-LLO immunotherapy with an anti-PD-1
antibody. These forward-looking statements are subject to a number of
risks, including the risk factors set forth from time to time in
Advaxis' SEC filings, including but not limited to its report on Form
10-K for the fiscal year ended October 31, 2012, which is available at http://www.sec.gov.
The Company 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.
Copyright Business Wire 2013