LOS ANGELES, Nov. 21, 2016 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT:IMUC) announced the
presentation of updated immune monitoring data from the phase 2
trial of ICT-107 in patients with newly diagnosed glioblastoma.
Also presented were updated long-term survival data from the phase
1 trial of ICT-107. ICT-107 is a dendritic cell-based immunotherapy
targeting multiple tumor-associated antigens on glioblastoma stem
cells. ICT-107 is currently being tested in a phase 3 registration
trial in patients with newly diagnosed glioblastoma. The updated
phase 1 and phase 2 data were presented in two oral sessions on
Friday, November 18th, at
the 21st Annual Scientific Meeting and Education Day of the Society
for Neuro-Oncology, held in Scottsdale,
AZ.
The ICT-107 phase 2 trial was a randomized, double-blind,
placebo-controlled phase 2 study of the safety and efficacy of
ICT-107 in patients with newly diagnosed glioblastoma following
resection and chemoradiation. ICT-107 is an intradermally
administered autologous immunotherapy consisting of the patient's
own dendritic cells pulsed with six synthetic tumor-associated
antigens: AIM-2, MAGE-1, TRP-2, gp100, HER-2, IL-13Rα2. The placebo
control consisted of the patient's unpulsed dendritic cells. The
data from the phase 2 trial indicated a survival advantage in the
ICT-107 treated group compared to the control group. The data also
showed an association between immune response and survival,
especially in HLA-A2 positive (HLA-A2+) patients, which is the
target patient population for the ongoing phase 3 registration
trial.
The updated immune response data from the phase 2 trial showed
that treatment with ICT-107 resulted in the development of a
measurable anti-tumor T cell response in some patients, which was
associated with survival. Patients that developed the anti-tumor T
cell response which was measurable by both ELISpot (to detect
viable T cells capable of binding to a target antigen) and multimer
testing (to detect T cell binding with higher sensitivity than
ELISpot) had improved survival. The data demonstrated that
immuno-monitoring can provide an early indication of patients
responding to immunotherapy. In the current ongoing phase 3
registration trial of ICT-107, ImmunoCellular plans to perform
immuno-monitoring to support the trial.
The data were presented at SNO by Steven
J. Swanson, PhD, Senior Vice President, Research,
ImmunoCellular Therapeutics, in a presentation titled,
"Categorizing immune responders with fusion metrics and simulation
for association to survival and progression-free survival with
immune response in HLA-A2+ patients with GBM from a phase 2 trial
of dendritic cell (DC) immunotherapy (ICT-107)."
Dr. Swanson commented: "ICT-107 is designed to deliver
therapeutic benefit by stimulating the patient's immune system to
attack tumor tissue. A first indicator that the immunotherapeutic
is active is the production of tumor-specific T cells by the
patient. In our SNO presentation, we described our ability to
more clearly interpret the immune-monitoring data from the phase 2
trial. The ability to accurately identify negative and
positive responses enabled us to better understand which of the
patients in our trial generated T cells capable of attacking the
tumor. We determined that patients with a T cell response
measureable in both the ELIspot assay and through multimer analysis
achieved longer survival as compared with patients who did not show
a positive response. These data should enable us to better
interpret the results of our ongoing phase 3 trial."
Andrew Gengos, ImmunoCellular
Chief Executive Officer, said: "The phase 2 trial immune monitoring
results indicate that patients who mount a T cell response appear
to have improved survival over those without a detectable
response. In designing the phase 3 trial, we have made
important changes in the protocol to potentially enhance the immune
response in ICT-107 treated patients with the goal of optimizing
the potential survival outcomes in the trial."
Data from the phase 1 trial of ICT-107 were presented by
Surasak Phuphanich, MD, Department
of Neurology, Cedars-Sinai in Los
Angeles, in a presentation titled "Ten-year follow up with
long term remission in patients with newly diagnosed glioblastoma
(GBM) treated with ICT-107 vaccine (phase 1)." The phase 1
open-label, single institution trial, which was completed in 2010,
included 16 evaluable patients with newly diagnosed glioblastoma.
Results of the study were initially published in 2012 (Cancer
Immunol Immunother).
Updated survival data presented by Dr. Phuphanich at the 2016
SNO meeting showed that 19% of patients had long-term remission of
greater than 8 years, with the longest remission being 9.6 years.
Also, 38% of patients demonstrated long-term survival of greater
than 8 years, with the longest survivor greater than 10.2 years.
Immune response data showed a correlation between survival and
cancer-stem-associated expression, and a trend toward greater CD8 T
cell cytokine responses in long-term survivors.
ICT-107 Phase 3 Registration Trial Underway
The ongoing phase 3 registrational trial of ICT-107 is designed
as a randomized, double-blind, placebo-controlled study of HLA-A2+
subjects, which is being conducted at about 120 sites in the US,
Canada and the EU, with plans to
randomize at least 500 patients with newly diagnosed glioblastoma.
The primary endpoint in the trial is overall survival. Secondary
endpoints include progression-free survival and safety, as well as
overall survival in the two pre-specified MGMT subgroups.
For patients, families and physicians seeking additional
information about the ICT-107 phase 3 trial, please consult
www.clinicaltrials.gov.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that
is developing immune-based therapies for the treatment of brain and
other cancers. The phase 3 registrational trial of lead product
candidate, ICT-107, a patient-specific, dendritic cell-based
immunotherapy targeting multiple tumor-associated antigens on
glioblastoma stem cells, has been initiated. ImmunoCellular's
pipeline also includes: ICT-121, a patient-specific, dendritic
cell-based immunotherapy targeting the CD133 antigen on stem cells
in recurrent glioblastoma; ICT-140, a patient-specific, dendritic
cell-based immunotherapy targeting antigens on ovarian cancer stem
cells; and the Stem-to-T-cell research program which engineers the
patient's hematopoietic stem cells to generate antigen-specific
cancer-killing T cells. To learn more about ImmunoCellular, please
visit www.imuc.com.
Forward-Looking Statements for ImmunoCellular Therapeutics
This press release contains certain forward-looking statements,
including statements regarding ImmunoCellular's intentions and
current expectations concerning, among other things, timing for
enrollment and randomization of patients, the activation of
clinical sites, the receipt and announcement of clinical data; the
development and commercialization of ICT-107; the development of
our preclinical Stem-to-T-cell program and ImmunoCellular's ability
to achieve its other clinical, operational and financial goals.
Forward-looking statements are not guarantees of future performance
and are subject to a number of risks and uncertainties, including
the availability of resources to continue to develop
ImmunoCellular's product candidates, the uncertain timing of
completion and success of clinical trials, and the risk that
ICT-107 can be further successfully developed or
commercialized. Additional risks and uncertainties are
described under the heading "Risk Factors" in ImmunoCellular's most
recently filed quarterly report on Form 10-Q and annual report on
Form 10-K. Except as required by law, ImmunoCellular undertakes no
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Contact:
ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
jane@jmgcomm.com
Logo -
http://photos.prnewswire.com/prnh/20140109/AQ43875LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/immunocellular-therapeutics-reports-updated-immune-monitoring-data-from-ict-107-phase-2-trial-in-newly-diagnosed-glioblastoma-at-the-society-for-neuro-oncology-annual-meeting-2016-300366250.html
SOURCE ImmunoCellular Therapeutics, Ltd.