Yisheng Biopharma Starts Enrollment in Phase 1 Immuno-Oncology Clinical Trial of YS-ON-001 in Patien

Yisheng Biopharma Co., Ltd. ("Yisheng Biopharma"), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immuno-oncology products and vaccines, today announced that the first patient with advanced stage cancer was enrolled in a Phase I immuno-oncology trial of YS-ON-001, a lead product candidate for the treatment of advanced solid tumors. 

YS-ON-001 is an investigational biological product that demonstrates broad immuno-modulating effects, such as induction of anti-tumor cytokines, activation of NK cells, regulation of macrophage polarization, and suppression of regulatory T cells. The U.S. Food and Drug Administration (FDA) granted YS-ON-001 orphan drug designation (ODD) for the treatment of hepatocellular carcinoma in 2016.

Dr. Lee Soo Chin, the Principal Investigator of the clinical program at the National University Cancer Institute, Singapore (NCIS), commented, "We are pleased to carry out the clinical study of YS-ON-001 in patients with advanced solid tumors, which was designed to investigate its clinical safety, tolerability and preliminary anti-tumor activity of YS-ON-001 in patients with advanced solid tumors. This open label study starts with dose escalation cohorts followed by cohort expansion in patients with advanced breast and liver cancers."

"Today's news is an important development milestone as we advance YS-ON-001 into the clinic.  We are grateful to the National University Cancer Institute, Singapore (NCIS) for supporting the YS-ON-001 trial, and excited about the product being actively studied in patients with advanced solid tumors, where there are limited treatment options," said Yi Zhang, Chairman and Chief Executive Officer. "YS-ON-001 is an emerging immuno-oncology product with its unique immunological mechanisms. It demonstrated robust anti-tumor activity against breast, lung, liver and other cancers as compared to the first-line chemotherapies or targeted therapies in animal studies.   The animal studies did not reveal significant safety concerns.   We believe YS-ON-001 has great potential as a novel therapy for cancer patients. As the drug is entering clinical development phase in multiple countries, we look forward to working closely with the regulatory authorities in various territories to bring this potentially beneficial therapy to patients."

About YS-ON-001

YS-ON-001 is a clinical stage biological product based on our proprietary technology developed in-house at Yisheng Biopharma.  It is a multi-component complex with broad immunomodulating properties, such as promoting Th1-biased immunity, inducing the activation and proliferation of dendritic cell (DC), B and natural killer cells (NK cells), promoting macrophage M1 polarization and downregulating regulatory T cells. YS-ON-001 demonstrates excellent efficacy in animal studies against multiple solid tumors, such as breast, lung, liver and other cancers. Toxicology studies in animals also demonstrated good safety of the product. 

About Yisheng Biopharma Co., Ltd.

Yisheng Biopharma Co., Ltd. is a biopharmaceutical company headquartered in Beijing, China, focusing on the research, development, manufacturing and sales and marketing of immunological and vaccine products, with approximately 1000 employees in China, the USA and Singapore.