Project Outline


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Malignant Brain Tumors

Target Market Overview
Brain tumors may be classified as primary brain tumors, defined as neoplasms originating within the brain itself, and metastatic brain tumors, which are tumors that have spread to the brain from elsewhere in the body. It was reported that the incidence of primary brain tumors is 11~12 cases per 100,000 people annually. In fact, the total number of patients in Japan with primary brain tumors is approximately 13,000 to 14,000 people (General Rules for Clinical and Pathological Studies on Brain Tumors, The Community of Brain Tumor Registry of Japan, The Japanese Pathological Society, second edition, 2002).
Glioblastoma is highly feared as the type of malignant tumor most refractory to any treatment by current medical technologies.

Technical Background
We are developing a personalized peptide cancer vaccine, ITK-1, which can be used for the treatment of advanced HRPC and grade 4 malignant brain tumors.
The efficacy of these peptides to malignant brain tumors has already been confirmed by exploratory clinical research carried out by academic institutes including the Kurume University School of Medicine.

Research and Development Overview
We have already filed an IND application with the PMDA and started Phase I trials of personalized peptide vaccines for treatment of malignant brain tumors (glioblastoma).
Our target patients are HLA-A24(+) and are refractory to initial treatment (radiation therapy or combination chemotherapy and radiation therapy after surgery). We are administering personalized peptide vaccines without any concomitant drugs to confirm the safety and efficacy of the peptide vaccine.
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