Immuno-Oncology Biotherapeutics
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PIKA-based Biotherapeutics
Disruption of Tumor Growth through Multiple Steps of Immune Activation
YS-ON-001
PIKA-enabled Anticancer Product Candidate
YS-ON-001 consists of a complex of protein and PIKA immunomodulating agent and is designed to reduce immunosuppressive effects within the tumor microenvironment and enhance antitumor immune responses. YS-ON-001 can be delivered via intramuscular, subcutaneous or intratumoral injection and has demonstrated a high rate of tumor growth inhibition in preclinical studies with models of breast, lung, liver, colorectal, prostate and other cancers.
In preclinical studies YS-ON-001 has demonstrated the ability to enhance macrophage phagocytosis, upregulate the activation of dendritic cells, natural killer cells and T cells, induce the production of multiple tumor-inhibitory cytokines and increase tumor cell apoptosis. Preclinical studies of the immune response in the tumor microenvironment have demonstrated that in addition to increasing CD4+ and CD8+ T-cell responses, YS-ON-001 can also significantly increase the proportion of natural killer and natural killer T cells. In several tumor models, administration of YS-ON-001 resulted in the reduction in the number of T regulatory cells and myeloid-derived suppressor cells. At the same time, M2 subtype macrophages of the tumor microenvironment reverse polarity to become M1 macrophages, enhancing the antitumor immune response.
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The multiple mechanisms of action for YS-ON-001 suggest potential for development as a combination therapy with standard of care chemotherapies, targeted therapies, checkpoint inhibitors or with emerging cancer immunotherapies. YS-ON-001 has demonstrated antitumor efficacy as a standalone therapy and has demonstrated synergistic effects when combined with PD-1 checkpoint inhibition. Preclinical studies have also demonstrated enhanced anticancer activity of YS-ON-001 when combined with targeted therapies or cytotoxic agents.
YS-ON-001 has received Orphan Drug Designation from the U.S. FDA for development of the treatment for both hepatocellular cancer and pancreatic cancer. YS-ON-001 is currently in clinical development for advanced solid tumors.
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