LOS ANGELES, March 6, 2017 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT:IMUC) today
provided an update on the Company's ICT-107 phase 3 registration trial in newly
diagnosed glioblastoma, and announced advances in its
Stem-to-T-cell Research program.
ICT-107 Phase 3 Trial in Newly Diagnosed Glioblastoma Update
As previously disclosed, ImmunoCellular submitted an amendment
of the ICT-107 phase 3 protocol to
the US FDA. The key change in this amendment will enable patients
to be randomized 30 days after commencing screening procedures,
accelerating the time to randomization by approximately 2
months.
"We are pleased to announce that the amendment is currently
being implemented at US clinical sites and that amended protocol
submissions are underway in Europe
and Canada," said Anthony Gringeri, PhD, ImmunoCellular President
and Chief Executive Officer. "As anticipated, as a result of the
protocol change, the Special Protocol Assessment (SPA) which was
based on the original protocol, is no longer applicable. We will
engage in further discussions with the FDA concerning the SPA in
the future. The change in the status of the SPA will not materially
impact the execution of the phase 3 trial, and data generated from
this phase 3 study can still be used as primary evidence to support
a marketing application."
Advances in the Stem-to-T-Cell Research Program
ImmunoCellular today announced successful completion of the
first milestone for the Company's Stem-to-T-cell program, the
sequencing of a selected T cell receptor (TCR) gene. When inserted
into a blood stem cell, this TCR gene is expected to enhance
patients' immune systems to produce killer T cells programmed to
attack tumors. This Stem-to-T-cell
therapeutic strategy has the potential to provide a safer,
sustainable and more specific immune treatment for cancer.
"We are excited that our Stem-to-T-cell program is advancing well and look
forward to working with our collaborators at The University of Texas MD Anderson Cancer Center to
develop antigen-specific killer T cells. This approach potentially
represents a major advance in cancer immunotherapy and may overcome
the challenge of short-lived T cell responses seen with the present
forms of T cell and CAR-T therapies," said Steven J. Swanson, PhD, ImmunoCellular's Senior
Vice President, Research.
Achieving this milestone required completion of several critical
steps: the collection and analysis of multiple clones of cells
containing the target TCR genes, harvesting the plasmids with the
TCR gene, and then sequencing that gene. Next, ImmunoCellular
Therapeutics will initiate development of the gene therapy
component. This phase entails loading the TCR gene sequence into a
viral vector (such as a lentivirus) for delivery into the patient's
hematopoietic stem cells which could become, in essence, an
internal factory producing antigen-specific killer T cells. Once
these fundamental elements are in place, a product candidate for
testing in cell lines and suitable preclinical models may be
generated. Successful testing would potentially lead to human
clinical trials.
In November 2015, ImmunoCellular
entered into a sponsored research agreement with MD Anderson, with
Dr. Cassian Yee as principal
investigator, which focused on identifying T cells that find and
kill tumor cells expressing a target antigen. The ultimate goal of
this work is to establish a clinical program based on hematopoietic
stem cells that are isolated from the patient, modified with the
TCR gene sequence, and then returned to the patient. These modified
stem cells would continually produce antigen-specific killer T
cells that target and kill the tumor.
ImmunoCellular plans to provide a more detailed update on the
ICT-107 phase 3 trial and the Stem-to-T-cell program when it
reports fourth quarter and full year 2016 financial results in
March.
About ImmunoCellular's Stem-to-T-Cell Program
ImmunoCellular's Stem-to-T-cell program seeks to create
antigen-specific cytotoxic or "killer" T cells that attack tumors
in patients. Autologous hematopoietic stem cells (HSCs) are
collected from cancer patients and transfected using a T cell
receptor sequence that recognizes the patient's tumor. After
transfection, the HSCs would be administered to the patient. These
transfected HSCs, now containing the T cell receptor gene, would
migrate to the patient's bone marrow and re-establish residence. In
addition to replicating transformed HSCs, these cells would begin
producing cytotoxic T cells specifically targeting the patient's
tumor. These cytotoxic T cells would migrate to the tumor location
and begin the process of tumor destruction. This renewable
population of killer T cells provides ongoing surveillance to
prevent disease recurrence.
ImmunoCellular's collaboration with the University of Maryland, established in January 2016, is designed to enhance the
Company's dendritic cell (DC) and stem cell technology platforms.
It is comprised of three projects currently underway. In the first
project, collaborators have screened and identified FDA approved
small molecule drugs that behave effectively like checkpoint
inhibitors, and potentially preventing cancer cells from evading
the immune system. These small molecules appear to down-regulate
important tumor features, such as the PD-1 ligand on the surface of
the tumor cells, and also up-regulate the display of tumor specific
antigens. If successfully developed, they could be used in
combination with ImmunoCellular's DC or Stem-to-T-cell therapies,
augmenting their ability to recognize and kill tumors cells.
A second project represents new ways to engineer T cells for
combination with DC immunotherapy by amplifying T cell properties
directed toward tumor antigens. A third project focuses on
modifying antigens for enhanced DC immunotherapy, including novel
peptide configurations for use in DC-based products to induce
enhanced T cell responses.
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 Company's lead product candidate, ICT-107, is a
patient-specific, dendritic cell-based immunotherapy targeting
glioblastoma and is currently being studied in an international
phase 3 trial. ImmunoCellular's pipeline also includes: ICT-121, a
patient-specific, dendritic cell-based immunotherapy targeting
CD133 found in recurrent glioblastoma; ICT-140, a patient-specific,
dendritic cell-based immunotherapy targeting ovarian cancer; and
the Stem-to-T-cell research program which engineers hematopoietic
stem cells to generate cytotoxic 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, the
development of the preclinical Stem-to-T-cell program and whether
any early stage research programs can lead to successful
development of product candidates for human clinical trials; timing
for enrollment and randomization of patients in ongoing clinical
trials and the receipt and announcement of clinical data; the
development and commercialization of ICT-107; 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
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SOURCE ImmunoCellular Therapeutics, Ltd.