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Release of Summary Report of YNP01 Phase I study

A Summary Report of the specified clinical trial “A phase I study of combination immunotherapy with HSP70 derived peptide, GPC3 derived peptide, IMP321 and Hiltonol for patients with advanced or metastatic solid cancer” (YNP01 study) was submitted to the Ministry of Health, Labor and Welfare (Chugoku-Shikoku Welfare Bureau) by Yamaguchi University Graduate School of Medicine, and an overview of the Summary Report has been released from JRCT (Japan Registry of Clinical Trials).
This First-in-Human phase I study was performed to evaluate the safety, peptide-specific immune responses, and antitumor effects of vaccination therapy comprising multi-HLA-binding HSP70/ glypican-3 peptides and a novel adjuvant combination of Poly-ICLC and LAG-3Ig. AI-designed peptide prediction enabled the discovery of multi-HLA binding and immunogenic epitope peptides, and the combination of Poly-ICLC and LAG-3Ig are expected to boost antitumor effects of these multi-HLA peptides synergistically.
Cytlimic continues to advance the development of CYT001 through collaborations with medical centers, based on the results and knowledges gained from the YNP01 study.
URL: https://jrct.niph.go.jp/en-latest-detail/jRCTs061180058
(Brief Summary)
This phase I study evaluated the safety, peptide-specific CTL, and antitumor effects of a novel vaccination therapy comprising multi-HLA-binding HSP70/GPC3 peptides and adjuvants of LAG-3Ig and Poly-ICLC against gastrointestinal cancers. Seventeen patients received therapy without DLT. Peptide-specific CTL induction by HSP70 and GPC3 proteins was observed in 11 and 13 cases. Tumor markers were decreased in 10 cases. This novel peptide vaccination therapy was safe and effective for patients with GI cancer.
YNP01 study - PI: Hiroaki Nagano, MD, PhD, Professor and Chairman, Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Co-Investigator: Shoichi Hazama, MD, PhD, Professor, Department of Translational Research and Developmental Therapeutics against Cancer, Yamaguchi University Graduate School of Medicine, Collaboration: CYTLIMIC Inc.

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