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Presentation of interim results of YCP02 study at AACR 2020

Interim analysis results of the specified clinical trial “A phase I study of combination adjuvant immunotherapy with HSP70 derived peptide, GPC3 derived peptide, IMP321 and Hiltonol for patients with resectable hepatocellular carcinoma” (YCP02 study, Yamaguchi University Graduate School of Medicine) of CYT001 were presented at AACR (American Association for Cancer Research) Virtual Annual Meeting (June 22-24, 2020).
The results of histopathological and immunological analyses of surgical specimens of 9 patients who received neoadjuvant vaccination of CYT001 were reported as a poster. As concluded in the poster, tumor cell death and infiltration of T cells into tumor regions were observed in 6 patients (“Hot” patients), where, in two patients, the tumor cell death was also confirmed as the decrease of tumor stain of post-vaccination CT (computed tomography) image from that of pre-vaccination. However, no evidence of tumor cell death or T cell infiltration was observed in the remaining 3 patients (“Cold” patients). It is also notable that the population of key marker (PD-1, TIGIT, or CD39) positive CD8+ TILs (tumor infiltrated lymphocytes) were significantly higher in “Hot patients” than in “Cold patients”.
The inclusion of patients will be continued at Yamaguchi University Graduate School of Medicine, until the end of September 2020 or the number of included patients reaches 20.
Title and authors are following:
Title: Immunological and histopathological tumor responses of a novel neoadjuvant peptide vaccine (CYT001) targeting HSP70 and GPC3 antigens in patients with resectable HCC
Authors: Masao Nakajima1, Shoichi Hazama1, Koji Tamada1, Keiko Udaka2, Shun Doi3, Michiie Sakamoto4, Akira Saito5, Shiro Akinaga6, Hiroto Matsui1, Yoshitaro Shindo1, Satoshi Matsukuma1, Yukio Tokumitsu1, Shinobu Tomochika1, Michihisa Iida1, Shin Yoshida1, Ryouichi Tsunedomi1, Yuki Nakagami1, Nobuaki Suzuki1, Shigeru Takeda1, Naoya Kato7, Hiroaki Nagano1
  1. Yamaguchi University, Ube, Yamaguchi, Japan
  2. Kochi University, Nangoku, Kochi, Japan
  3. CYTLIMIC Inc., Shinagawa, Tokyo, Japan
  4. Keio University, Shinjukuku, Tokyo, Japan
  5. Tokyo Medical University, Shinjukuku, Tokyo, Japan
  6. AccuRna Incorporation, Bunkyoku, Tokyo, Japan
  7. Chiba Yuniversity, Chuoku, Chiba, Japan
 

YCP02 study:A phase I study of combination adjuvant immunotherapy with HSP70 derived peptide, GPC3 derived peptide, IMP321 and Hiltonol for patients with resectable hepatocellular carcinoma (PI: Hiroaki Nagano, MD, PhD, Professor and Chairman, Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University School of Medicine, Co-Investigator: Shoichi Hazama, MD, PhD, Professor, Department of Translational Research and Developmental Therapeutics against Cancer, Yamaguchi University School of Medicine, Collaboration: Cytlimic Inc.) (jRCTs061180033, (https://jrct.niph.go.jp/en-latest-detail/jRCTs061180033)

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