Advaxis Presents New Data Featuring Its Lm Technology™ at the Society for Immunotherapy of Cancer 2015 Annual Meeting
November 09 2015 - 9:05AM
High-dose axalimogene filolisbac immunotherapy
will advance to expansion phase
Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company
developing cancer immunotherapies, presented a poster featuring
clinical development advances with its Lm Technology™ at the
Society for Immunotherapy of Cancer 2015 Annual Meeting in National
Harbor, Md. The purpose of this study was to evaluate whether
axalimogene filolisbac could be dosed at higher levels than
previous studies conducted by Advaxis in patients with persistent
or recurrent metastatic (squamous or non-squamous cell) carcinoma
of the cervix (PRmCC).
While previous clinical studies of axalimogene
filolisbac were evaluated at 1 x 109 CFU, data from this Phase 1
dose escalation study showed axalimogene filolisbac may be safely
administered with prophylactic antibiotics up to 1 x 1010 CFU, a
tenfold increase. Higher doses of axalimogene filolisbac have been
shown pre-clinically to correlate with increased antigen
presentation and greater targeted anti-tumor activity.
Clinical data from the ongoing Phase 1/2
clinical trial reported the first evidence for the safety and
tolerability of axalimogene filolisbac at higher doses in patients
with PRmCC. In the study, a total of 27 cycles of therapy were
delivered at the 5 x 109 CFU dose level and to date, 5 cycles at
the high dose of 1 x 1010 CFU, which will now constitute the
randomized Phase 2 dose (RP2D). The adverse events observed at the
high dose are consistent with previous experience.
“I’m extremely excited about this study because
we have evaluated doses of axalimogene filolisbac at 5 and 10 times
the level currently administered in the clinical trial program to
date, with the goal of evaluating whether the increased dose and
protein expression may lead to greater clinical benefit,” said
principal investigator Sharad Ghamande, M.D., Director of
Gynecology Oncology at GRU Cancer Center, Georgia Regents
University in Augusta, Ga. “Importantly, even at higher doses, the
adverse event profile continues to be predominantly grade 1 grade
2, transient events, self-resolving within hours or resolving
promptly with the introduction of anti-inflammatory
medications.”
The RP2D will now be explored further in an
expansion cohort in subjects with PRmCC.
About Cervical Cancer
Cervical cancer is the fourth most common cancer
and the most common cause of mortality in women worldwide. In the
United States, nearly 13,000 new cases are diagnosed and
approximately 4,100 deaths are reported because of cervical cancer.
According to the WHO/ICO Information Centre on HPV and Cervical
Cancer, about 3.9 percent of women in the U.S. are estimated to
harbor high-risk cervical HPV infection at a given time, and 71.7
percent of invasive cervical cancers are attributed to high-risk
HPV strains.
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 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.
Clinical trials of axalimogene filolisbac have
been placed on clinical hold by the FDA. Advaxis is working closely
with the FDA and expects this clinical hold will be resolved
expeditiously and without significant interruption to the HPV
clinical development program.
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 immunotherapies. 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.
CONTACTS: |
|
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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