GC Biopharma Corp. Begins Phase 2/3 Trial of High-Immunogenicity Influenza Vaccine

[Financial News] GC Biopharma Corp. is accelerating development of a high-immunogenicity influenza vaccine targeting older adults.
GC Biopharma Corp. announced on the 4th that the Ministry of Food and Drug Safety had approved the investigational new drug (IND) application for a Phase 2/3 clinical trial of its high-immunogenicity influenza vaccine candidate, GC3114B.
The trial will involve adults aged 65 and older. An existing influenza vaccine will serve as the active comparator, allowing researchers to directly compare it with GC3114B and evaluate immunogenicity and safety. GC Biopharma Corp. plans to begin dosing the first participants in the Phase 2 trial in the second half of this year. Starting in Phase 3, the trial will be conducted as a multinational study across several countries.
GC3114B is a vaccine candidate designed to contain a higher amount of antigen than a standard-dose influenza vaccine. As immune function declines with age, older adults may not develop a sufficient immune response after vaccination. This has led to the development of high-immunogenicity vaccines designed to induce a relatively stronger immune response.
The use of high-immunogenicity influenza vaccines among older adults is also expanding overseas. The Advisory Committee on Immunization Practices (ACIP) under the Centers for Disease Control and Prevention (CDC) recommends that adults aged 65 and older receive high-immunogenicity vaccines in preference to standard-dose vaccines.
In South Korea, the need to expand influenza prevention options for older adults is also growing. As the country enters a super-aged society, calls are increasing for a wider range of vaccine choices to prevent influenza among older people.
The Korea Disease Control and Prevention Agency (KDCA) is also considering introducing high-immunogenicity influenza vaccines into the National Immunization Program (NIP). GC Biopharma Corp. plans to enter the domestic NIP market, establish a foundation for local production of high-immunogenicity influenza vaccines that currently rely on imports, and expand into overseas markets.
Jae Woo Lee, head of development at GC Biopharma Corp., said, "As the population ages rapidly, the importance of influenza prevention strategies that take the immune characteristics of older adults into account is growing. We will strengthen our business competitiveness by expanding our product portfolio to include high-immunogenicity influenza vaccines, leveraging our research and development and manufacturing capabilities."
Meanwhile, GC Biopharma Corp. is expanding its influenza vaccine business, recently signing a partnership with French vaccine developer Osivax for the development and commercialization of next-generation influenza vaccines.
[email protected] Sang-hee Jung Reporter