Despite significant advances in medicine and technology, cancer and in-58fectious diseases remain serious threats to humanity. Immune check blockade (ICB) therapy has demonstrated great clinical utility for a few patients with a sustained response. Unfortunately, most patients do not respond to ICB. Concerning infectious diseases, the 21st century has seen a series of severe in-fectious disease outbreaks, led by the COVID-19 pandemic, that have had dev-astating effects on lives and livelihoods around the world.The artificial adjuvant vector cell (aAVC) drug translational research unit promotes aAVC drug platform technology, as one of the RIKEN’s original mo-dalities for oncology and infectious diseases. The unit will prepare for clinical studies using aAVC-tumor associated antigens (TAA) or -viral antigens (VA) by selecting those for which basic immunological data have been confirmed (Figure). In other words, the aAVC drug TR unit will perform CMC (Chemistry, Manufacturing, and Control), a series of processes necessary to actually create a drug product (quality control, toxicity testing, etc.), and produce aAVC-TAA or - VA for preclinical studies. Then, it will confirm the safety and efficacy in a va-riety of preclinical studies. In addition, it supports not only aAVC-TAA or -VA production in accordance with Good Manufacturing Practices but also consults with the Pharmaceuticals and Medical Devices Agency for clinical trials.We have recently reported that aAVC-WT1 induces immunological re-sponses as well as clinical responses in a phase I clinical trial. Currently, we are conducting a Phase II clinical trial for patients with early-stage acute myelog-enous leukemia in collaboration with IMSUT, Chiba University, and Kagawa University. We have also demonstrated the possibility of using aAVC-expressing a viral antigen as an antiviral vaccine therapy. Since aAVC is a platform, the an-tigens can easily be replaced, and we will attempt to apply this strategy for vari-ous cancers and infectious diseases.Figure: The aAVC drug TR unit works for translational research (TR). The basic research component of TR includes scien-tific inquiry that reveals the fundamental mechanisms of biology, disease, and behavior. All phases of TR build on basic research. Preclinical research links the basic science of disease with human medicine. In this phase, we need to establish interventional models to further understand the basis of a disease or disorder and find ways to treat it. Clinical research includes studies aimed at better understanding diseases in humans and relat-ing this knowledge to findings in animal models. This is crucial for testing and refining new technologies in humans, as well as for assessing the safety and efficacy of interventions.Recent Major PublicationsFujii S, Shimizu K. NKT-Licensed In Vivo Dendritic Cell–Based Immunotherapy as Cellular Immunodrugs for Cancer Treatment. Crit Rev Oncogenesis 29, 45-61 (2024)Shimizu K, Ueda S, Kawamura M, Aoshima H, Satoh M, Nakabayashi J, Fujii S. Combination of cancer vaccine with CD122-biased IL-2/anti-IL-2 Ab complex shapes the stem-like effector NK and CD8+ T cells against tumor. J Immunother Cancer 11, e006409 (2023)Iyoda T, Yamasaki S, Ueda S, Shimizu K, Fujii S. Natural Killer T and Natural Killer Cell-Based Immunotherapy Strategies Targeting Cancer. Biomolecules 13, 348 (2023)Invited presentationsFujii S. “Artificial adjuvant vector cells with multifunc-tionality for cancer and infectious disease.” Faculty De-velopment in Hiroshima University, School of Medicine (Hiroshima, Japan) December 2023Fujii S. “Therapeutic cellular vaccine eliciting multifunc-tional immunity against cancer” The 82nd Annual Meet-ing of the Japanese Cancer Association (Tokyo, Japan) September 2023Fujii S. “Development of monitoring system of antigen-specific T cells against infectious disease~Influenza viral model~.” The 1st Joint Symposium of Kyoto University and RIKEN-IMS as Support Institutions (Kyoto, Japan) August 2023Fujii S. “Therapeutic vaccine eliciting multifunctional immunity, artificial adjuvant vector cells (aAVC)” RIKEN IMS-JSI International Symposium on Immunology 2023 (Tokyo, Japan) June 2023Fujii S. “Novel Immunotherapeutic vaccine, artificial adjuvant vector cells eliciting both innate and adaptive immunity.” The 20th Annual Meeting of Japan Research Association for Immunotherapeutics. (Tokyo, Japan) June 2023aAVC Drug Translational UnitUnit Leader: Shin-ichiro Fujii
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