Safety and antibody immune response of CHP-NY-ESO-1 vaccine combined with poly-ICLC in advanced or recurrent esophageal cancer patients

The nanoparticle complex of cholesteryl pullulan (CHP) and NY-ESO-1 antigen protein (CHP-NY-ESO-1) presents multiple epitope peptides to MHC class I and II pathways, leading to CD8 + and CD4 + T cell responses. Poly-ICLC is a synthetic, double-stranded RNA, an agonist of toll-like receptor (TLR)-3,...

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Veröffentlicht in:Cancer Immunology, Immunotherapy Immunotherapy, 2021-11, Vol.70 (11), p.3081-3091
Hauptverfasser: Ishikawa, Takeshi, Kageyama, Shinichi, Miyahara, Yoshihiro, Okayama, Tetsuya, Kokura, Satoshi, Wang, Linan, Sato, Eiichi, Yagita, Hideo, Itoh, Yoshito, Shiku, Hiroshi
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container_end_page 3091
container_issue 11
container_start_page 3081
container_title Cancer Immunology, Immunotherapy
container_volume 70
creator Ishikawa, Takeshi
Kageyama, Shinichi
Miyahara, Yoshihiro
Okayama, Tetsuya
Kokura, Satoshi
Wang, Linan
Sato, Eiichi
Yagita, Hideo
Itoh, Yoshito
Shiku, Hiroshi
description The nanoparticle complex of cholesteryl pullulan (CHP) and NY-ESO-1 antigen protein (CHP-NY-ESO-1) presents multiple epitope peptides to MHC class I and II pathways, leading to CD8 + and CD4 + T cell responses. Poly-ICLC is a synthetic, double-stranded RNA, an agonist of toll-like receptor (TLR)-3, and a cytoplasmic receptor of melanoma differentiation-associated gene (MDA)-5. It should be a suitable immune adjuvant of cancer vaccine to overcome the inhibitory tumor microenvironment. We conducted a phase 1 clinical trial of CHP-NY-ESO-1 with poly-ICLC in patients with advanced or recurrent esophageal cancer. CHP-NY-ESO-1/poly-ICLC (μg/mg) was administered at a dose of 200/0.5 or 200/1.0 (cohorts 1 and 2, respectively) every 2 weeks for a total of six doses. The primary endpoints were safety and immune response. The secondary endpoint was tumor response. In total, 16 patients were enrolled, and six patients in each cohort completed the trial. The most common adverse event (AE) was injection site skin reaction (86.7%). No grade 3 or higher drug-related AEs were observed. No tumor responses were observed, and three patients (30%) had stable disease. The immune response was comparable between the two cohorts, and all patients (100%) achieved antibody responses with a median of 2.5 vaccinations. Comparing CHP-NY-ESO-1 alone to the poly-ICLC combination, all patients in both groups exhibited antibody responses, but the titers were higher in the combination group. In a mouse model, adding anti-PD-1 antibody to the combination of CHP-NY-ESO-1/poly-ICLC suppressed the growth of NY-ESO-1-expressing tumors. Combining the vaccine with PD-1 blockade holds promise in human trials.
doi_str_mv 10.1007/s00262-021-02892-w
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Poly-ICLC is a synthetic, double-stranded RNA, an agonist of toll-like receptor (TLR)-3, and a cytoplasmic receptor of melanoma differentiation-associated gene (MDA)-5. It should be a suitable immune adjuvant of cancer vaccine to overcome the inhibitory tumor microenvironment. We conducted a phase 1 clinical trial of CHP-NY-ESO-1 with poly-ICLC in patients with advanced or recurrent esophageal cancer. CHP-NY-ESO-1/poly-ICLC (μg/mg) was administered at a dose of 200/0.5 or 200/1.0 (cohorts 1 and 2, respectively) every 2 weeks for a total of six doses. The primary endpoints were safety and immune response. The secondary endpoint was tumor response. In total, 16 patients were enrolled, and six patients in each cohort completed the trial. The most common adverse event (AE) was injection site skin reaction (86.7%). No grade 3 or higher drug-related AEs were observed. No tumor responses were observed, and three patients (30%) had stable disease. The immune response was comparable between the two cohorts, and all patients (100%) achieved antibody responses with a median of 2.5 vaccinations. Comparing CHP-NY-ESO-1 alone to the poly-ICLC combination, all patients in both groups exhibited antibody responses, but the titers were higher in the combination group. In a mouse model, adding anti-PD-1 antibody to the combination of CHP-NY-ESO-1/poly-ICLC suppressed the growth of NY-ESO-1-expressing tumors. 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Poly-ICLC is a synthetic, double-stranded RNA, an agonist of toll-like receptor (TLR)-3, and a cytoplasmic receptor of melanoma differentiation-associated gene (MDA)-5. It should be a suitable immune adjuvant of cancer vaccine to overcome the inhibitory tumor microenvironment. We conducted a phase 1 clinical trial of CHP-NY-ESO-1 with poly-ICLC in patients with advanced or recurrent esophageal cancer. CHP-NY-ESO-1/poly-ICLC (μg/mg) was administered at a dose of 200/0.5 or 200/1.0 (cohorts 1 and 2, respectively) every 2 weeks for a total of six doses. The primary endpoints were safety and immune response. The secondary endpoint was tumor response. In total, 16 patients were enrolled, and six patients in each cohort completed the trial. The most common adverse event (AE) was injection site skin reaction (86.7%). No grade 3 or higher drug-related AEs were observed. No tumor responses were observed, and three patients (30%) had stable disease. The immune response was comparable between the two cohorts, and all patients (100%) achieved antibody responses with a median of 2.5 vaccinations. Comparing CHP-NY-ESO-1 alone to the poly-ICLC combination, all patients in both groups exhibited antibody responses, but the titers were higher in the combination group. In a mouse model, adding anti-PD-1 antibody to the combination of CHP-NY-ESO-1/poly-ICLC suppressed the growth of NY-ESO-1-expressing tumors. Combining the vaccine with PD-1 blockade holds promise in human trials.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>33751208</pmid><doi>10.1007/s00262-021-02892-w</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-7682-3295</orcidid><oa>free_for_read</oa></addata></record>
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source MEDLINE; SpringerNature Journals; PubMed Central
subjects Adjuvants, Immunologic - therapeutic use
Adverse events
Aged
Aged, 80 and over
Animals
Antibodies
Antigens, Neoplasm - immunology
Antigens, Neoplasm - therapeutic use
Cancer
Cancer Research
Cancer vaccines
Cancer Vaccines - immunology
Cancer Vaccines - therapeutic use
Carboxymethylcellulose Sodium - analogs & derivatives
Carboxymethylcellulose Sodium - therapeutic use
CD4 antigen
CD8 antigen
Clinical trials
Combined vaccines
Double-stranded RNA
Epitopes
Esophageal cancer
Esophageal Neoplasms - drug therapy
Esophageal Neoplasms - immunology
Esophagus
Female
Glucans - immunology
Glucans - therapeutic use
Humans
Immunology
Immunotherapy
Interferon Inducers - immunology
Interferon Inducers - therapeutic use
Lymphocytes T
Major histocompatibility complex
Male
Medicine
Medicine & Public Health
Melanoma
Membrane Proteins - immunology
Membrane Proteins - therapeutic use
Mice
Middle Aged
Nanoparticles
Oncology
Original
Original Article
Patients
PD-1 protein
Poly I-C - immunology
Poly I-C - therapeutic use
Polylysine - analogs & derivatives
Polylysine - immunology
Polylysine - therapeutic use
Toll-like receptors
Tumor microenvironment
Tumors
Vaccines
title Safety and antibody immune response of CHP-NY-ESO-1 vaccine combined with poly-ICLC in advanced or recurrent esophageal cancer patients
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