Gynecologic
Oncology Group (GOG) Phase 2 Study of Advaxis's Lm-LLO Immunotherapy, ADXS-HPV,
for the Treatment of Persistent or Recurrent Cervical Cancer Achieves Safety
and Efficacy Criteria
a clinical-stage
biotechnology company developing cancer immunotherapies, announced an update
related to the Phase 2 open-label clinical study of ADXS-HPV (ADXS11-001) in
patients with persistent or recurrent cervical cancer with documented disease
progression being conducted by the Gynecologic Oncology Group (GOG), now part
of NRG Oncology. The study, known as GOG 0265, has completed its first stage and
has met the predetermined safety and efficacy criteria required to proceed into
the second stage of patient enrollment. This trial is being conducted in the
U.S. by the GOG, under the sponsorship of the Cancer Therapy Evaluation Program
(CTEP) of the National Cancer Institute (NCI).
GOG 0265 is an open-label,
single arm 2-stage study designed to evaluate the safety, tolerability and
efficacy of ADXS-HPV in approximately 67 patients. Patients receive one cycle
(three doses) of ADXS-HPV at 1 x 109 cfu every 28 days. The primary efficacy
endpoint is 12-month survival, with secondary efficacy endpoints of
progression-free survival, overall survival and objective tumor response. The
primary safety endpoints are the number of patients with dose-limiting toxicities
and the frequency and severity of adverse effects. Stage 1 enrolled 29 patients
and stage 2 is set to enroll another 38. Further information about GOG 0265 can
be found on ClinicalTrials.gov, using Identifier NCT01266460.
Dr. Warner Huh, Principal
Investigator for GOG 0265 commented, "We are encouraged by the data to
date and are looking forward to moving to the second stage of enrollment and
completion of the GOG 0265 study. Stage
1 patients that are still alive will continue to be followed for survival."
David Mauro, MD, Chief
Medical Officer of Advaxis stated, "We are very pleased this Phase 2 study
of ADXS-HPV in recurrent cervical cancer conducted by the GOG has reached the
predefined 12 month survival rate and safety measures to justify opening up the
second part of the study to an additional 37 patients."
Daniel J. O'Connor,
President and CEO of Advaxis, commented, "This is one of the most
significant milestones that we have reached in the ADXS-HPV clinical
development program to date. We are now seeing independent support for the data
that we observed in our own Phase 2 clinical trial. Our support for
investigator-initiated research like that being done by the GOG exemplifies our
strategy to leverage our assets and advance our clinical programs through key
collaborations and partnerships with leading clinical research institutions and
pharmaceutical companies."
About the Gynecologic Oncology Group
The Gynecologic Oncology
Group (GOG), now part of NRG Oncology, is a non-profit international
organization with the purpose of promoting excellence in the quality and
integrity of clinical and basic scientific research in the field of Gynecologic
malignancies. The GOG is committed to maintaining the highest standards in
clinical trials development, execution, analysis and distribution of results.
Continuous evaluation of its processes is utilized in order to constantly
improve the quality of patient care. The GOG conducts clinical trials for
patients with a variety of gynecologic malignancies, including cancers that
arise from the ovaries, uterus, cervix, vagina, and vulva. General information
on many of these trials for medical professionals and the lay public can be
obtained from the clinicaltrials.gov.
NRG Oncology is one of
four adult cooperative groups funded under the newly structured NCI National
Clinical Trials Network. NRG Oncology is comprised of three legacy cooperative
groups, the National Surgical Adjuvant Breast and Bowel Project (NSABP), the
Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group
(GOG).
About Advaxis, Inc.
Advaxis is a
clinical-stage biotechnology company developing multiple cancer immunotherapies
based on its proprietary Lm-LLO platform technology. The 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 myeloid-derived suppressor cells (MDSCs), that protect the
tumor microenvironment from immunologic attack and contribute to tumor growth.
Advaxis's lead Lm-LLO 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 2015 and has established licensing
partners in India and Asia for commercialization in those regions. Advaxis
entered into a clinical trial collaboration with MedImmune, the global
biologics research and development arm of AstraZeneca, for a Phase 1/2
immunotherapy study to evaluate the safety and efficacy of MedImmune's
investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in
combination with Advaxis's ADXS-HPV as a treatment for patients with advanced,
recurrent or refractory HPV-associated cervical cancer and HPV-associated head
and neck cancer.
Advaxis's second Lm-LLO
immunotherapy candidate in clinical testing will be ADXS-PSA, which is being
developed to address prostate cancer. Advaxis entered into a clinical trial
collaboration agreement with Merck & Co., Inc. ("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 PD-1 checkpoint inhibitor KEYTRUDA® (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.
Advaxis is also developing
Lm-LLO immunotherapy ADXS-HER2, to target the HER2 receptor expressing cancers.
HER2 is expressed in certain solid-tumor cancers, including pediatric bone
cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer.
ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug
Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing
ADXS-HER2 for both human and animal-health, and has seen encouraging data in
canine osteosarcoma, which is considered a model for human osteosarcoma.
Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to
Aratana Therapeutics, Inc. for pet therapeutics.
