China Authorizes Cancer Immunotherapy Study

A Bejing China biopharmaceutical company announced that it has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China to initiate a clinical trial of Iveka (YS-ON-001), a cancer vaccine therapy. 

Iveka is a first-in-class immuno-cancer product and has demonstrated a highly effective tumor growth inhibition in preclinical studies with models of breast, lung, liver, colorectal, prostate and other cancers. 

In 2018, YS-ON-001 received Orphan Drug Designation from the U.S Food and Drug Administration for development of the treatment for both hepatocellular cancer and pancreatic cancer. 

This is important news since the AmericanCancer Society's estimates about 56,770 people (29,940 men and 26,830 women) will be diagnosed with pancreatic cancer in 2019. 

Pancreatic cancer starts in the type of cells that help break down food (exocrine cells). But there's another, less common type of pancreatic cancer that starts from the cells that make hormones (endocrine cells). 

Currently, the main ways to treat pancreatic cancer are surgery, chemotherapy, and radiation therapy, says Cancer.org. 

YS-ON-001 was granted a drug registration license by the Ministry of Health of the Kingdom of Cambodia in 2018. Iveka is being marketed as YivykaTM in the Cambodia market. 

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 is capable of increasing CD4+ and CD8+ T-cell responses, increasing the proportion of natural killer and natural killer T cells and promoting higher expression level of PD-L1 receptors in tumor tissues.   

YS-ON-001 also showed a reduction in the number of T regulatory cells and myeloid-derived suppressor cells. 

Immunotherapies enhance the cancer-fighting activity of the immune system in a variety of ways, which can be roughly divided into the 5 following classes: 

1. Cell-based immunotherapies physically supplement patients’ immune systems with immune cells. These include bone marrow transplants and newer more sophisticated cell transplants, such as CAR T cells.
2. Immunomodulators can act directly on immune cells to promote anti-cancer activity.
3. Vaccines help educate or arouse the immune system against a potential threat. In 1990, a tuberculosis vaccine called BCG (bacillus Calmette-Guerin), became the first to be FDA-approved in the United States, for the treatment of bladder cancer.
4. Antibody-based targeted therapies can target cancer cells directly, or other cells/proteins that help support tumor survival. The first antibody (the anti-CD20 rituximab) was approved in 1997 for lymphoma.
5. Oncolytic viruses can be modified to infect cancer cells and cause them to burst (think of dynamite!), which attracts the attention of the immune system.

"We plan to move forward with the clinical development of YS-ON-001 in China to bring it to the market as efficiently as possible," commented David Shao, Ph.D., President and Chief Executive Officer of Yisheng Biopharma. 

Yisheng Biopharma is a global, fully integrated biopharmaceutical company engaged in discovering, developing and commercializing innovative biotherapeutics for cancer and infectious disease using its novel PIKA® immunomodulating technology.