Beijing-based Yisheng Biopharma Co. is celebrating this morning after its lead immunology treatment snagged a second Orphan Drug Designation from the U.S. Food and Drug Administration.
Beijing-based YiSheng BioPharma is celebrating this morning after its lead immunology treatment snagged a second Orphan Drug Designation from the U.S. Food and Drug Administration.
This morning the company shared the news that its early stage treatment YS-ON-001 scored the ODD for pancreatic cancer. In 2016 the FDA granted YS-ON-001 Orphan Drug Designation for hepatocellular carcinoma.
“The orphan drug designation of YS-ON-001 in pancreatic cancer is an important regulatory milestone as it will accelerate our clinical development in this particular oncology indication where pancreatic cancer is one of the deadliest cancers and is estimated to be the fourth leading cause of cancer-related death in the United States in 2018, according to the American Cancer Society,” Hui Shao, Yisheng’s president and chief executive officer said in a statement.
The FDA’s Orphan Drug Designation is awarded to treatments that are deemed as a potentially effective treatment for rare diseases/disorders that affect fewer than 200,000 people in the United States. If Yisheng is able to bring YS-ON-001 to market in the United States the Orphan Drug Designation would entitle the company to a seven-year period of marketing exclusivity.
Yisheng’s YS-ON-001 was developed in-house. The company called it a “multi-component complex with broad immunomodulating properties.” Those immunomodulating properties include the promotion of Th1-biased immunity, the induction of the activation and proliferation of dendritic cell (DC), B and natural killer cells (NK cells), promotion of macrophage M1 polarization and downregulating regulatory T cells, the company said. In pre-clinical work, YS-ON-001 showed efficacy against multiple solid tumors including those in breast, lung, liver and pancreatic cancers.
In May 2017 the company dosed its first patient with YS-ON-001 in a Phase I trial for the treatment of advanced solid tumors. The Phase I trial is an open-label study that includes dose escalation followed by cohort expansion in patients with advanced breast and liver cancers, the company announced.
The drug is being tested as both a stand-alone treatment as well as in combination with other medications. In August 2017 Yisheng said YS-ON-001 demonstrated strong anti-tumor efficacy as a standalone therapy and “synergistic effect” when combined with antibody blocking programmed death receptor-1 (PD-1) in multiple animal models of solid tumors.
Zhang Yi, the project leader and chairman of Yisheng Biopharma, said the company believes it has “great potential” as a future treatment for pancreatic cancer and other solid tumors. He noted the early positive results the company has seen as both a stand-alone treatment and in combination with standard of care treatments and checkpoint inhibitors.
