Shigetaka Shimodaira, Koichi Hirabayashi, Takashi Kobayashi, Yumiko Higuchi and Kiyoshi Yokokawa
Dendritic cell (DC)-based immunotherapy has been developed against various types of cancers. To develop and promote regenerative medicine and cell therapy in Japan, the Act on the Safety of Regenerative Medicine and the Revised Pharmaceutical Affairs Law have been enforced since November 25, 2014. Therapeutic vaccination with active DCs was evaluated under the legal framework. Cancer vaccination therapies with autologous monocyte-derived mature DCs are principally attributed to the presence of tumor-associated antigens. Clinical studies and trials should be conducted in accordance with legislation for approval of either DC-based cancer therapy or DC vaccine products. The following issues with regards to DC-based vaccination and vaccine products for clinical use may be raised: 1) Manufacturing of DCs according to the standard grade of Good Gene, Cellular, and Tissue-based Products (GCTP) Manufacturing Practice; 2) Peptides that target cancer-associated antigens for any cancer patient; 3) Quality of immunological analyses as proof of concept; and 4) Optimization of DC vaccines as add-ons to chemotherapeutic drugs and/or radiotherapy to predict potential biomarkers of response. Phase II clinical trials that are covered by Advanced Medical Care System would be conducted on DC vaccine pulsed with Wilms’ tumor 1-specific MHC class I/II-restricted epitopes for pancreatic cancer. The designed clinical trial adopted with new technology could reveal the efficacy of DC vaccine in combination with optimized therapies. This would be relevant to the development of personalized therapy in cancer patients.
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