Monday, 12 March 2012

ImmunoCellular Therapeutics says manufacturing process for cancer vaccine shows "meaningful cost advantages"

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 treatments.
The process has also been optimized to produce high levels of certain cytokines that play a key role in initiating an immune response, ImmunoCellular said.
"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, ImmunoCellular added.
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.
ImmunoCellular Therapeutics is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers.

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