ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company that is developing immune based therapies for the treatment of various forms of cancer, announced today that the Company has entered into a sponsored research agreement and an option agreement with The University of Pennsylvania ("UPENN") to support process development and manufacturing in a planned Phase II clinical trial of ICT-107, the Company's dendritic-cell based cancer vaccine product candidate for the treatment of glioblastoma multiforme (GBM). GBM is the most common and aggressive form of brain cancer. In a Phase I clinical trial, ICT-107 demonstrated the ability to significantly extend in patients their overall survival time as well as tumor free survival time compared to the current standard of care.
“We look forward to validating the promising results demonstrated in the Phase I trial through a more extensive study in Phase II.”
The UPENN agreement will include process optimization with the goal of increasing yields such that in a single manufacturing run enough doses could be produced for 2-3 years of each patients vaccination and reduce the cost of manufacturing of each dose significantly. In addition, the optioned dendritic cell production technologies developed at UPenn could result in a higher potency as well as reduced time to manufacture these vaccines.
"We are pleased that such a prestigious institution as The University of Pennsylvania has agreed to participate in our research efforts surrounding ICT-107," said Manish Singh, Ph.D., ImmunoCellular Therapeutics' President and CEO. "We look forward to validating the promising results demonstrated in the Phase I trial through a more extensive study in Phase II."
ICT-107 is a dendritic-cell based vaccine that works by activating a patient's immune system against specific tumor-associated antigens. This is accomplished by extracting dendritic cells from a patient, loading them with the antigens, and reintroducing them to the patient's body to trigger an immune response.
In a recent Phase I study of ICT-107 in GBM, newly diagnosed patients who received the vaccine demonstrated a median progression-free survival (PFS) of 17.7 months after surgery. This compared favorably with the historical median PFS of 6.9 months observed with standard treatment with surgery, radiation and chemotherapy. Seven of the 16 patients (44%) who participated in the study continue to live with no disease progression with an average time over 2 years, which is significantly better than historical data of less than 15% disease free survival.
The six tumor-associated antigens used in ICT-107 are AIM2, Her-2/neu, gp-100, MAGE-1, TRP-2 and IL13Ra2. These antigens are highly expressed in GBM as well as a number other types of cancer, including breast, ovarian, colon and melanoma. In addition, three of these antigens are also highly expressed on cancer stem cells. ICT-107 may, therefore, be potentially applicable to multiple cancer types and may target both the bulk of the tumor as well as cancer stem cells, which are widely considered as roots of these tumors.
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