ImmunoCellular Therapeutics (OTCBB:IMUC) said Monday that its proprietary method for manufacturing ICT-107, its dendritic cell (DC)-based vaccine for an aggressive type of brain cancer, has shown better performance compared to other methods for producing DC-based immunotherapies.
The company said its method has proven "meaningfully enhanced
efficiency, consistency and convenience". Analysis of manufacturing
data showed that its process can produce up to 30 vials of ICT-107
product, and 30 vials of placebo in a single production run.
Shares of ImmunoCellular gained more than one percent in early trading Monday, to $2.68.
"These manufacturing data demonstrate the robustness of our
proprietary, innovative method for manufacturing ICT-107, reinforcing
our consistent and controlled ability to produce the vaccine for our
ongoing Phase II study," said president and CEO, Manish Singh.
"In addition, our ability to manufacture in a single run up to 30
doses of vaccine — a multi-year supply — points to meaningful cost
advantages over standard methods for producing DC vaccines," he added,
noting that the process for manufacturing Provenge, Dendreon’s
(NASDAQ:DNDN) DC-based vaccine for the treatment of prostate cancer,
requires multiple production runs for making three shots of vaccines
required for treatment.
ImmunoCellular's CEO Singh said that Dendreon's product cannot be
preserved for future use, resulting in significant costs in terms of
time, labor, shipping and administration.
Developed in collaboration with the company’s partners,
ImmunoCellular's manufacturing method uses a closed-bag system designed
to produce highly potent dendritic cells from white blood cells (WBCs)
collected from patients, and to preserve the cells for future vaccine
The process has also been optimized to produce high levels of certain
cytokines that play a key role in initiating an immune response,
"Despite variability in cell compositions collected from various
patients, the product consistently met the purity and viability criteria
reviewed by the U.S. Food and Drug Administration," the cell therapy
company said in a statement Monday.
Further, the final manufacturing process is not expected to require
"significant changes" prior to eventual commercialization,
ICT-107 is ImmunoCellular's lead dendritic cell-based cancer vaccine
candidate for the treatment of glioblastoma multiforme (GBM), an
aggressive type of brain cancer.
The vaccine, which is currently in phase two trials, works by
activating a patient's immune system against specific tumour associated
antigens for glioblastoma multiforme.
This is done by removing dendritic cells from a patient, loading them
with the tumour-related antigens, and re-injecting them back into the
patient's body to trigger an immune response against cancer cells
exhibiting these antigens.
In the natural human immune system, dendritic cells are responsible
for capturing, processing and presenting antigens to T-cells in the
immune system, which in turn target the antigens and destroy them.
These cells' conversion from antigen-capturing to antigen-presenting
mode, known as maturation, relies on the production of special messenger
cells known as cytokines.
"Based on the benefits our manufacturing process provides in terms of
efficiency, cost and convenience for both patient and physician, we are
confident in our ability not only to produce sufficient vaccine for
current and future clinical trials, but also to bring to market a
commercially viable product that has been shown to provide highly
significant and urgently needed improvements in survival outcomes for
patients with GBM," Singh concluded.
Indeed, progression-free and overall survival times for GBM patients
treated with ICT-107 during the company's phase one trial of the drug
continue to be substantially longer than those associated with standard
of care (SOC) alone.
In September 2011, ImmunoCellular reported its three-year data, which
indicated an overall survival of 55 percent, compared to 16 percent
based on historical SOC.
Of the 16 newly diagnosed patients who received ICT-107, 38 percent
continue to show no tumor recurrence after three years, compared to the
historic disease-free survival rate of 6 percent with SOC.
Out of these patients, 19 percent remain disease-free after more than four years.
is a Los Angeles-based clinical-stage company that is developing
immune-based therapies for the treatment of brain and other cancers.