GCMinistery of Food and Drug Safety said on the 4th that it received approval from the Ministery of Food and Drug Safety for the phase 2/3 clinical trial protocol (IND) of its high-immunogenicity flu vaccine candidate "GC3114B."
The trial will evaluate the immunogenicity and safety of GC3114B in adults 65 and older by directly comparing it with an active control. GC Biopharma plans to begin dosing the first patient in phase 2 in the second half of this year and expand to a multinational phase 3.
GC3114B is a vaccine developed to elicit a stronger immune response in older adults by increasing the antigen content compared with standard-dose flu vaccines. Because aging diminishes immune function in the elderly, sufficient immune responses may not form after vaccination, making high-immunogenicity flu vaccines relatively more necessary.
Globally, the use of high-immunogenicity flu vaccines for older adults is expanding. The Advisory Committee on Immunization Practices (ACIP) under the U.S. Centers for Disease Control and Prevention (CDC) recommends that adults 65 and older receive high-immunogenicity vaccines over standard-dose vaccines.
In Korea, as the country enters a super-aged society, the need to expand flu prevention options for older adults is growing. The Korea Disease Control and Prevention Agency is recently reviewing the introduction of high-immunogenicity flu vaccines into the National Immunization Program (NIP).
GC Biopharma aims to enter the domestic high-immunogenicity flu vaccine market, which currently relies on imports, through GC3114B and to establish a foundation for localization. It also plans to pursue entry into global markets afterward.
It is also accelerating the expansion of its flu vaccine business. Recently, it signed a partnership with Osivax, a French vaccine development corporations, for the development and commercialization of next-generation flu vaccines, broadening its business scope in the flu vaccine market.
Lee Jae-woo, head of development at GC Biopharma, said, "As population aging accelerates, the importance of flu prevention strategies that consider the immune characteristics of older adults is growing," and added, "We will further strengthen our business competitiveness by expanding our portfolio to high-immunogenicity flu vaccines, based on the company's long-accumulated research and development and manufacturing capabilities."