Immunogenicity and safety to be evaluated in adults 65 and older
First Phase 2 dose expected in second half of this year; Phase 3 to go multinational
Company aims to end reliance on imported high-immunogenicity vaccines
Green Cross said Friday that the Ministry of Food and Drug Safety has approved an investigational new drug application for Phase 2 and Phase 3 clinical trials of GC3114B, its high-immunogenicity influenza vaccine candidate.
The trials will evaluate GC3114B's immunogenicity and safety in adults 65 and older through direct comparison with an active control. Green Cross plans to administer the first dose in the Phase 2 trial in the second half of this year, with Phase 3 to be conducted as a multinational study.
GC3114B contains more antigen than a standard-dose flu vaccine, triggering a stronger immune response in older adults.
Because immune function declines with age, older adults may not mount an adequate immune response even after vaccination. Demand for high-immunogenicity flu vaccines has been growing globally as a result. The Advisory Committee on Immunization Practices, which operates under the US Centers for Disease Control and Prevention, recommends that adults 65 and older receive a high-immunogenicity vaccine over a standard-dose vaccine.
In South Korea, the need to broaden flu prevention options for the elderly is growing as the country enters super-aged society status. The Korea Disease Control and Prevention Agency is reviewing whether to include high-immunogenicity flu vaccines in the National Immunization Program.
Green Cross aims to enter the National Immunization Program market and build a domestic supply base for high-immunogenicity flu vaccines, which currently depend on imports. The company also plans to pursue global markets on the back of its multinational clinical program.
"As the population ages rapidly, the importance of flu prevention strategies tailored to the immune characteristics of older adults is growing," said Lee Jae-woo, head of Green Cross's development division. "We will expand our portfolio to include high-immunogenicity flu vaccines, drawing on our long-accumulated research, development and production capabilities, and further strengthen our business competitiveness."
Green Cross is targeting regulatory approval for the high-immunogenicity flu vaccine within three years and has also begun securing production capacity ahead of commercialization. In July, the company signed an MOU with Korea Vaccine to cooperate on CMO services, agreeing to build a manufacturing and supply chain for the high-immunogenicity flu vaccine using prefilled syringe production facilities.
boo@heraldcorp.com
