Safety and Immunogenicity of Cholesterol-Bearing Hydrophobized Pullulan HER2 Protein 146 (CHP-HER2) and NY-ESO-1 Protein (CHP-NY-ESO-1) in Combination With OK-432 in HER2- and/or NY-ESO-1-Expressing Cancers

Mixed cancer vaccines, CHP-HER2 protein and CHP-NY-ESO-1 protein, are to be studied to evaluate the safety and immune responses in patients who are positive either or both antigens. Nine patients will be enrolled, who are refractory to standard therapies for cancer or at high risk to relapse. CHP-HER2 and CHP-NY-ESO-1 are subcutaneously given on bimonthly basis, together with OK-432(Picibanil) as an immunoadjuvant. Six doses will be given. Toxicity profiles will be monitored, and antigen specific humoral anad T cell responses will be described.

开始日期2005-07-01

申办/合作机构

Ludwig Institute for Cancer Research Ltd.

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100 项与 CHP-HER2(Mie University) 相关的临床结果

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100 项与 CHP-HER2(Mie University) 相关的转化医学

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100 项与 CHP-HER2(Mie University) 相关的专利（医药）

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项与 CHP-HER2(Mie University) 相关的文献（医药）

2008-03-01·Cancer Science2区 · 医学

Humoral immune responses in patients vaccinated with 1–146 HER2 protein complexed with cholesteryl pullulan nanogel

2区 · 医学

ArticleOA

作者: Michiko Hirayama ; Eric W. Hoffman ; Kazunari Akiyoshi ; Naoyuki Katayama ; Roger Murphy ; Shigehisa Kitano ; Yasuhiro Nagata ; Hiroshi Imai ; Hiroshi Shiku ; Taizo Shiraishi ; Shinichi Kageyama ; Andrew M. Scott ; Lloyd J. Old

The CHP‐HER2 vaccine, comprising truncated 146HER2 protein complexed with nanogels of cholesteryl pullulan (CHP), is a novel protein antigen vaccine that elicits 146HER2‐specific CD8+ and CD4+ T‐cell immune responses in patients with HER2‐expressing tumors. We analyzed the humoral responses in patients vaccinated with CHP‐HER2 and those with CHP‐HER2 plus granulocyte‐macrophage colony‐stimulating factor (GM‐CSF). The vaccine was injected subcutaneously at a dose of 300 µg protein. Nine patients received the vaccine alone over the first four injections, followed by CHP‐HER2 with GM‐CSF or OK‐432, whereas six received CHP‐HER2 plus GM‐CSF from the first cycle. 146HER2‐specific IgG antibodies were induced in 14 patients, who were negative at baseline. The antibodies became detectable after the second or third vaccination and reached plateau levels after the third or fourth cycle in patients vaccinated with CHP‐HER2 plus GM‐CSF. In contrast, the antibodies appeared only after the third to sixth vaccination and the plateau appeared after the fourth to eighth cycle in patients vaccinated with the CHP‐HER2 vaccine alone over the first four cycles. The antibodies induced by the vaccine were not reactive with HER2 antigen expressed on the cell surface in any of the patients. Epitope analysis using overlapping peptides revealed a single region in the 146HER2 protein, amino acids 127–146, in eight patients who were initially vaccinated with CHP‐HER2 alone. Similarly, the same HER2 region was recognized dominantly in patients vaccinated with GM‐CSF. Our results indicate that CHP‐HER2 induced HER2‐specific humoral responses in patients with HER2‐expressing tumors and that GM‐CSF seems to accelerate the responses. (Cancer Sci 2008; 99: 601–607)

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	临床1期	日本	Mie University	2005-07-01
乳腺癌	临床1期	日本	Ludwig Institute for Cancer Research Ltd.	2005-07-01
食管癌	临床1期	日本	Ludwig Institute for Cancer Research Ltd.	2005-07-01
食管癌	临床1期	日本	Mie University	2005-07-01
HER2表达癌症	临床1期	日本	Ludwig Institute for Cancer Research Ltd.	2005-07-01
HER2表达癌症	临床1期	日本	Mie University	2005-07-01
肺癌	临床1期	日本	Mie University	2005-07-01
肺癌	临床1期	日本	Ludwig Institute for Cancer Research Ltd.	2005-07-01
卵巢癌	临床1期	日本	Ludwig Institute for Cancer Research Ltd.	2005-07-01
卵巢癌	临床1期	日本	Mie University	2005-07-01