GC Green Cross-Baekses, Announces Phase 1 Clinical Trial Results of Patch-Type Influenza Vaccine

Patch-type Influenza Vaccine 'MIMIX-Flu'
Shows Strong Immunogenicity Data Over 180 Days

GC Green Cross announced on the 7th that it has released the Phase 1 clinical trial results of the patch-type influenza vaccine 'MIMIX-Flu,' co-developed with the U.S. company Bexess Technologies.

GC Green Cross headquarters exterior.
[Photo by GC Green Cross]

MIMIX-Flu is a product that combines GC Green Cross's influenza vaccine antigen (H1N1) with Bexess's patch-based subcutaneous drug delivery system called MIMIX.

The results are based on data collected over a total of 180 days, including the interim results announced in December last year. The study was conducted on 45 healthy adults aged 18 to 39, evaluating the drug's safety, reactogenicity, tolerability, and immunogenicity compared to a placebo group.

Regarding immune response, the company explained that MIMIX-Flu induced not only consistently high immunogenicity over 180 days but also cross-reactivity. Antibody and neutralizing antibody titers against the vaccine virus strain increased significantly in the trial subjects, and the seroconversion rate and seroprotection rate met the U.S. Food and Drug Administration (FDA) guideline standards. Additionally, a strong correlation between hemagglutination inhibition (HAI) antibodies and neutralizing antibody titers was confirmed, along with cross-immune responses against virus strains with different sublineages from the vaccine virus strain.

In terms of safety, local and systemic reactions occurring within 7 days after vaccination were similar to those in the placebo group. No reports of pain, bruising, or tenderness were noted, and mild headache and fatigue were observed as systemic reactions.

Furthermore, there was no significant difference in virus titers between the two dosage levels. The company explained that this indicates no difference in immunogenicity compared to the existing dose, even with a lower dose.

Linda Tursi, Chief Development Officer of Bexess, stated, "One of the most notable points in these results is that the MIMIX patch showed potential protection against variant viruses," adding, "This means that the patch-type vaccine can enhance the effectiveness of influenza vaccines much more comfortably than administering vaccines through traditional syringes."

MIMIX-Flu features microneedles attached to the patch that allow the vaccine drug to be slowly delivered, enabling appropriate control of the drug delivery speed and duration. It can be shipped without the need for refrigerated distribution and is characterized by almost no pain.

This content was produced with the assistance of AI translation services.