Advaxis’s Cancer Immunotherapies to be Featured in Three Poster Presentations at the 2015 SITC Annual Meeting
October 13 2015 - 9:05AM
Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage
biotechnology company developing cancer immunotherapies, today
announced that three abstracts featuring Advaxis’s Lm Technology™
cancer immunotherapies have been selected for poster presentation
at the Society for Immunotherapy of Cancer’s (SITC) 30th
Anniversary Annual Meeting & Associated Programs, November 6-8,
2015, at Gaylord National Hotel & Convention Center in National
Harbor, Md.
The poster presentations featuring Advaxis
immunotherapies at SITC 2015 include:
- Cohen et al., Phase I/II study of ADXS11-001 or MEDI4736
immunotherapies alone and in combination, in patients with
recurrent/metastatic cervical or human papillomavirus
(HPV)-positive head and neck cancer.
- Haas et al., Phase 1-2 study of ADXS31-142 alone and in
combination with pembrolizumab in patients with previously treated
metastatic castration-resistant prostate cancer (mCRPC): The
KEYNOTE-046 trial.
- Ghamande et al., High-dose treatment with ADXS11-001, a
Listeria monocytogenes (Lm)-listeriolysin O (LLO) immunotherapy, in
women with cervical cancer.
The first poster will feature an ongoing Phase
1/2 clinical trial of Advaxis’s lead immunotherapy candidate
axalimogene filolisbac (ADXS-HPV) in combination with MedImmune's
investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab
(MEDI4736), for the treatment of patients with advanced, recurrent
or refractory HPV-associated cervical cancer and HPV-associated
head and neck cancer.
The second poster will feature an ongoing Phase
1/2 clinical trial (KEYNOTE-046) evaluating the combination of
ADXS-PSA and Merck’s PD-1 checkpoint inhibitor KEYTRUDA®
(pembrolizumab) in patients with previously treated, metastatic
castration-resistant prostate cancer (mCRPC). The KEYNOTE-046 trial
is the first-in-human study of ADXS-PSA and the second study
initiated to evaluate the use of KEYTRUDA® in advanced prostate
cancer.
Data from preclinical studies suggest that
Advaxis's Lm Technology™ immunotherapies in combination with a
checkpoint inhibitor, such as durvalumab or KEYTRUDA®, may lead to
an enhanced anti-tumor immune response. Results from these two
studies will determine the future clinical development program for
both combinations.
The third poster will include preliminary data
from an ongoing Phase 1/2 clinical trial of axalimogene filolisbac
at a high dose in patients with recurrent or refractory cervical
cancer. Cervical cancer is the fourth most common cancer and the
most common cause of mortality in women worldwide.
About Axalimogene
Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis's
lead Lm Technology™ immunotherapy candidate for the treatment of
HPV-associated cancers and is in clinical trials for three
potential indications: invasive cervical cancer, head and neck
cancer, and anal cancer. In a completed randomized Phase 2 study in
recurrent/refractory cervical cancer, axalimogene filolisbac showed
apparent prolonged survival, objective tumor responses, and a
manageable safety profile alone or in combination with
chemotherapy, supporting further development of the company’s Lm
Technology™.
About ADXS-PSA
ADXS-PSA is an Lm Technology™ immunotherapy
under investigation for targeting the prostate-specific antigen
(PSA) associated with prostate cancer. ADXS-PSA is in clinical
development both as a monotherapy and in combination with immune
checkpoint inhibitors for the treatment of metastatic
castration-resistant prostate cancer (mCRPC).
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a
clinical-stage biotechnology company developing multiple cancer
immunotherapies based on its proprietary Lm Technology™. The Lm
Technology™, using bioengineered live attenuated Listeria
monocytogenes (Lm) 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
myeloid-derived suppressor cells (MDSCs) that protect the tumor
microenvironment from immunologic attack and contribute to tumor
growth. Advaxis's lead Lm Technology™ immunotherapy, axalimogene
filolisbac, targets human papillomavirus (HPV)-associated cancers
and is in clinical trials for three potential indications: Phase 2
in invasive cervical cancer, Phase 1/2 in head and neck cancer, and
Phase 1/2 in anal cancer. The U.S. Food and Drug Administration
(FDA) has granted axalimogene filolisbac orphan drug designation
for each of these three clinical settings. Advaxis has two
additional immunotherapy products, ADXS-PSA in prostate cancer and
ADXS-HER2 in HER2 expressing solid tumors, in human clinical
development. For additional information on Advaxis, visit
www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube
and Google+.
Forward-Looking Statements
This media statement contains forward-looking
statements, including, but not limited to: statements regarding
Advaxis’s ability to develop the next generation of cancer
immunotherapies; and the safety and efficacy of Advaxis’s
proprietary immunotherapy, axalimogene filolisbac. 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, 2014, 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.
KEYTRUDA® is a registered trademark of Merck & Co., Inc.
Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.452.9813 ext. 102
Media Contact:
JPA Health Communications
Carolyn Sobczyk
carolyn@jpa.com
402.718.3974
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