Set to evaluate the safety and tolerability of PD-1 antibody, YBL006, in patients with solid cancers such as lung cancer and melanoma, with plans to register patients at Seoul National University Hospital and Seoul National University Bundang Hospital​

 

 

 

Y-Biologics has received a go-ahead from the Ministry of Food and Drug Safety for the Phase 1 clinical trial protocol for YBL-006, a PD-1 antibody developed for the first time in Korea. The company had previous received a clinical trial approval in Australia.

 

 

The antibody in question has been optimized after being derived based on Ymax-ABL, Y-Biologics’ naïve cDNA library of human antibodies. It has been patented in Korea, Australia, and other countries, and patent applications are currently under review in the United States among others.

 

 

In the domestic Phase 1 clinical trial, safety and tolerability in cancer patients such as lung cancer, melanoma, and head and neck cancer will be evaluated. The study will be conducted at Seoul National University Hospital and Seoul National University Bundang Hospital.

 

 

Based on the findings, the company will conduct a clinical trial of combination therapy with other anticancer drug candidates such as the LAG-3 antibody that it is currently developing.

 

 

The domestic market for PD-1/PD-L1 immune checkpoint inhibitors for anticancer therapy has been undergoing steady growth. Its size has surged from KRW 130 billion in 2018 to KRW 200 billion in 2019. However, without any domestically developed PD-1/PD-L1 drug granted marketing approval, multinational pharmaceutical companies are dominating the market.

 

 

In Korea, a limited number of patients are benefiting from the latest immuno-oncology drugs, due to the conflict caused by the high cost of the drugs that would pose a heavy financial burden on the national health insurance scheme if they were to be covered. If Y-Biologics’ YBL-006 can prove clinical safety and efficacy with respect to major types of cancer, more domestic patients will be able to benefit from immunotherapy.

 

 

Y-Biologics CEO Young Woo Park, stated, “The future of chemotherapy will be combination therapy with the use of an immuno-oncology drug and another type of anticancer agent, and clinical research is being actively conducted for this. [...] The localization of a PD-1 immuno-oncology drug, which is key to combination therapy for cancer, will help promote the treatment of cancer patients in Korea and ease the financial burden on the national health insurance scheme.”

 

By Sung Min Kim, sungmin.kim@bios.co.kr