FDA Grants Orphan Drug Designation to YS-ON-001 for the Treatment of Pancreatic Cancer

On February 26, Yisheng Biopharma Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to its lead immuno-oncology candidate, YS-ON-001, for the treatment of pancreatic cancer. 

YS-ON-001 is a clinical-stage immuno-oncology biologic product with unique immunomodulating mechanism and broad spectrum of antitumor activity.

“YS-ON-001 is an emerging immuno-oncology product with multiple modes of action in changing tumor microenvironment, such as induction of antitumor cytokines, activation of natural killer cells, regulation of macrophage polarization, and suppression of regulatory T cells.  We believe it has great potential to become a monotherapeutic agent or be combined with standard of care chemotherapies, targeted therapies, and checkpoint inhibitors, or with other emerging immunotherapies that produce additive or synergistic treatment effects," said Zhang Yi, Project Leader and Chairman of Yisheng Biopharma.

Orphan Drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis, or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States. 

About YS-ON-001

YS-ON-001 is a clinical stage biological product based on Yisheng Bipharma’s proprietary immunomodulating cell technology. It is a multicomponent complex with broad immunomodulating properties, such as promoting Th1-biased immunity; inducing the activation and proliferation of dendritic cell, B, and natural killer cells; promoting macrophage M1 polarization; and downregulating regulatory T cells. YS-ON-001 has demonstrated efficacy in animal studies in multiple solid tumors, such as breast, lung, liver, pancreatic, and other cancers. Toxicology studies in animals also demonstrated good safety of the product. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.