title: Guidance for peptide vaccines for the treatment of cancer.
abstract: Recent progress in fundamental understanding of tumor immunology has opened a new avenue of cancer vaccines. Currently, the development of new cancer vaccines is a global topic and has attracted attention as one of the most important issues in Japan. There is an urgent need for the development of guidance for cancer vaccine clinical studies in order to lead to drug development. Peptide vaccines characteristically have the effect of indirectly acting against cancer through the immune system - a mechanism of action that clearly differs from anticancer drugs that exert a direct effect. Thus, the clinical development of cancer peptide vaccines should be planned and implemented based on the mechanism of action, which differs significantly from conventional anticancer drug research. The Japanese Society for Biological Therapy has created and published Guidance for peptide vaccines for the treatment of cancer as part of its mission and responsibilities towards cancer peptide vaccine development, which is now pursued globally. We welcome comments from regulators and business people as well as researchers in this area.
authors.affiliation: Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Yamaguchi
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yamaue
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Okuno
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Suzuki
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Fujioka
authors.forename: Atsushi
authors.initials: A
authors.lastname: Otsu
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Rumiko
authors.initials: R
authors.lastname: Shimazawa
authors.forename: Kazuto
authors.initials: K
authors.lastname: Nishio
authors.forename: Junji
authors.initials: J
authors.lastname: Furuse
authors.forename: Hironobu
authors.initials: H
authors.lastname: Minami
authors.forename: Takuya
authors.initials: T
authors.lastname: Tsunoda
authors.forename: Yuzo
authors.initials: Y
authors.lastname: Hayashi
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Nakamura
mesh_terms: D019496:Cancer Vaccines / Q000494:pharmacology* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D006801:Humans; D009369:Neoplasms / Q000276:immunology* / Q000628:therapy; D011786:Quality Control; D022223:Vaccines, Subunit / Q000493:pharmacokinetics / Q000494:pharmacology*
chemical_list: D019496:Cancer Vaccines; D022223:Vaccines, Subunit
keywords: Cancer vaccines; clinical study; guidance; non-clinical study; peptide vaccines