A multi-center double-blind parallel-group placebo-control Phase II study on the efficacy of survivin-2B peptide vaccine therapy for patients with advanced or recurrent pancreatic cancer, and for which there is no effective treatment. - Phase II clinical study of vaccine therapy using survivin-2B peptide/STI01 for patients with advanced or recurrent pancreatic cancer. (SUCCESS-II)

Start Date16 Oct 2013

Sponsor / Collaborator-

JPRN-UMIN000008611 / CompletedPhase 1IIT

A single-center open-label parallel-group study on the efficacy and the safety of survivin-2B peptide vaccine therapy for patients with advanced or recurrent digestive organ cancer, for which there is no effective treatment. - Phase I clinical study of survivin-2B peptide vaccine therapy for patients with advanced or recurrent digestive organ cancer, for which there is no effective treatment.(SUCCESS)

Start Date30 Aug 2012

Sponsor / Collaborator-

JPRN-UMIN000000976 / CompletedPhase 1IIT

Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide for Patients with Oral Cancer - Phase I Clinical Study of Survivin-2B Peptide Vaccine Therapy

Start Date01 Sep 2003

Sponsor / Collaborator-

100 Clinical Results associated with Survivin 2b peptide vaccine(Sapporo Medical University)

100 Translational Medicine associated with Survivin 2b peptide vaccine(Sapporo Medical University)

100 Patents (Medical) associated with Survivin 2b peptide vaccine(Sapporo Medical University)

Literatures (Medical) associated with Survivin 2b peptide vaccine(Sapporo Medical University)

01 Feb 2020·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

Peptide vaccinations elicited strong immune responses that were reboosted by anti-PD1 therapy in a patient with myxofibrosarcoma

Q2 · MEDICINE

Article

Author: Watanabe, Kazue ; Hirohashi, Yoshihiko ; Hatae, Ryo ; Murai, Aiko ; Mizushima, Emi ; Takahashi, Akari ; Asanuma, Hiroko ; Sato, Noriyuki ; Torigoe, Toshihiko ; Kawahara, Rituko ; Murata, Kenji ; Hasegawa, Tadashi ; Kubo, Terufumi ; Ohno, Yasuo ; Tsukahara, Tomohide ; Nakatsugawa, Munehide ; Shibayama, Yuji ; Kanaseki, Takayuki ; Kameshima, Hidekazu ; Terui, Takeshi

Peptide-based immunotherapy does not usually elicit strong immunological and clinical responses in patients with end-stage cancer, including sarcoma. Here we report a myxofibrosarcoma patient who showed a strong clinical response to peptide vaccinations and whose immune responses were reboosted by anti-PD1 therapy combined with peptide vaccinations. The 46-year-old man showed a strong response to the peptide vaccinations (papillomavirus binding factor peptide, survivin-2B peptide, incomplete Freund's adjuvant, and polyethylene glycol-conjugated interferon-alpha 2a) and subsequent wide necrosis and massive infiltration of CD8+ T cells in a recurrent tumor. The patient's immune responses weakened after surgical resection; however, they were reboosted following the administration of nivolumab combined with peptide vaccinations. Thus, anti-PD1 therapy combined with peptide vaccinations might be beneficial, as suggested by the observations in this sarcoma patient.

01 Aug 2019·Cancer Science

Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA‐A24‐positive pancreatic adenocarcinoma

Article

Author: Ota, Yasunori ; Wada, Satoshi ; Tsurita, Giichiro ; Tsukahara, Tomohide ; Yasui, Hiroshi ; Miyakoshi, Takashi ; Imai, Kohzoh ; Murai, Aiko ; Hirata, Koichi ; Hirohashi, Yoshihiko ; Kutomi, Goro ; Hayashi, Hiroshi ; Ito, Yoichi M. ; Watanabe, Kazue ; Nakatsugawa, Munehide ; Torigoe, Toshihiko ; Kimura, Yasutoshi ; Kubo, Terufumi ; Kanaseki, Takayuki ; Takemasa, Ichiro ; Mizuguchi, Toru ; Sato, Noriyuki ; Sugita, Osamu ; Asanuma, Hiroko ; Tokita, Serina ; Nakae, Yutaka ; Shima, Hiroaki

AbstractThe prognosis of advanced pancreatic adenocarcinoma is still extremely poor. This study sought to determine the efficacy of, and immunological response to, peptide vaccination therapy in patients with this disease. In this multicenter randomized phase II study, patients with advanced pancreatic adenocarcinoma after gemcitabine and/or tegafur/gimeracil/oteracil were randomly assigned to 3 groups that each received a 2‐step treatment course. In Step 1, the groups received treatments of: (i) survivin 2B peptide (SVN‐2B) plus interferon‐β (IFNβ); (ii) SVN‐2B only; or (iii) placebo until the patients show progression. In Step 2, all patients who consented to participate received 4 treatments with SVN‐2B plus IFNβ. The primary endpoint was progression‐free survival (PFS) after initiation of Step 1 treatment. Secondary endpoints included immunological effects assessed by analysis of PBMCs after Step 1. Eighty‐three patients were randomly assigned to receive SVN‐2B plus IFNβ (n = 30), SVN‐2B (n = 34), or placebo (n = 19). No significant improvement in PFS was observed. Survivin 2B‐specific CTLs were found to be increased in the SVN‐2B plus IFNβ group by tetramer assay. Among patients who participated in Step 2, those who had received SVN‐2B plus IFNβ in Step 1 showed better overall survival compared with those who had received placebo in Step 1. Patients vaccinated with SVN‐2B plus IFNβ did not have improved PFS, but showed significant immunological reaction after vaccination. Subgroup analysis suggested that a longer SVN‐2B plus IFNβ vaccination protocol might confer survival benefit. (Clinical trial registration number: UMIN 000012146).

01 Aug 2019·Cancer ScienceQ2 · MEDICINE

Immunohistological analysis of pancreatic carcinoma after vaccination with survivin 2B peptide: Analysis of an autopsy series

Q2 · MEDICINE

ArticleOA

Author: Ota, Yasunori ; Kubo, Terufumi ; Hirata, Koichi ; Sato, Noriyuki ; Tsurita, Giichiro ; Nakatsugawa, Munehide ; Murai, Aiko ; Hirohashi, Yoshihiko ; Asanuma, Hiroko ; Tsukahara, Tomohide ; Kanaseki, Takayuki ; Imai, Kohzoh ; Torigoe, Toshihiko ; Wada, Satoshi ; Watanabe, Kazue ; Matsuo, Kazuhiko ; Shima, Hiroaki ; Takemasa, Ichiro ; Mizuguchi, Toru ; Yasui, Hiroshi

AbstractImmune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer by providing new options in addition to existing therapies. However, peptide vaccination therapies still represent an attractive approach, because of the antigen specificity. We identified survivin 2B peptide (SVN‐2B), a 9‐mer antigenic peptide encoded by survivin, and an SVN‐2B peptide vaccine‐based phase II randomized clinical trial targeting unresectable and refractory pancreatic carcinoma was undertaken. The SVN‐2B peptide vaccine did not have any statistically significant clinical benefits in that study. Therefore, we undertook an autopsy study to analyze the immune status of the pancreatic cancer lesions at the histological level. Autopsies were carried out in 13 patients who had died of pancreatic cancer, including 7 who had received SVN‐2B peptide vaccination and 6 who had not, as negative controls. The expression of immune‐related molecules was analyzed by immunohistochemical staining. Cytotoxic T lymphocytes were analyzed by tetramer staining and enzyme‐linked immunospot assay. Histological analysis revealed dense infiltration of CD8+ T cells in some lesions in patients who had received the SVN‐2B peptide vaccine. A high rate of programmed cell death ligand 1 expression in cancer cells was observed in these cases, indicating that CTLs were induced by SVN‐2B peptide vaccination and had infiltrated the lesions. The lack of a significant antitumor effect was most likely attributable to the expression of immune checkpoint molecules. These findings suggest that the combination of a tumor‐specific peptide vaccine and an ICI might be a promising approach to the treatment of pancreatic carcinoma in the future.

100 Deals associated with Survivin 2b peptide vaccine(Sapporo Medical University)

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Indication	Highest Phase	Country/Location	Organization	Date
Gastrointestinal Neoplasms	Phase 2	-	Sapporo Medical University	-

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