바이오스펙테이터

바이오스펙테이터 Naeun Bong 기자

The company has made an announcement on the development status of SOD targeting microbiome therapeutic agents, and plans to enter a global clinical trial of 'GF-103' by this year and also expects GF F

GenoFocus, which develops microbiome treatments, has announced its plan to prepare for a global clinical trial of 'GF-103,' a candidate therapeutic agent for wet age-related macular degeneration (Wet AMD) and inflammatory bowel disease (IBD). The company plans to complete the clinical trial design for AMD and to submit Investigational New Drug (IND) application to the FDA in the latter half of the year.

As most treatments for AMD, such as Eylea, an anti-vascular endothelial growth factor (anti-VEGF) injection, are directly injected into the inside of the eye, patients often complain about discomfort. In contrast, GF-103 with the equal efficacy as Eylea has differentiated advantages in terms of safety because it can be an orally administered microbiome-derived treatment.

GenoFocus has its own enzyme and protein engineering base technology of inducing the expression of a wanted protein from microorganisms and of mass-producing it and 'Spore Biologics' a platform of using spores as a vehicle to deliver protein drugs displayed on the spore surface. GenoFocus has developed microbiome-derived treatment drugs based on the above-mentioned core technologies since the early 2010s.

GenoFocus has been developing pipeline treatment drugs which are derived from eatable

Bacillus amyloliquefaciens. While it was conducting research on Bacillus amyloliquefaciens, the company found out the potential of 'Superoxide Dismutase,' an antioxidant enzyme protein and used it as a protein drug. CEO Kim Eui-Joong explains that the treatment drug can reduce free radicals (ROS) in an inflammation site to regulate oxidative stress and restore microbiome balance, which consequently leads to a relief of inflammation.

GenoFocus expands the scope of indications of the most promising candidate agent of ‘GF-103' to IBD and AMD. In the mouse model with laser-induced lesions, ‘GF-103' showed the same efficacy of reducing angiogenesis as Eylea and better recovery results of retinal function to light.

The most differentiated advantage of 'GF-103' is an safe orally-administered microbiome-derived treatment for AMD. Eylea is administered by injecting antibody into the inside of the eye once per month or once every two to three months. In contrast, 'GF-103' can be orally administered and provides the same treatment effect. CEO Kim said, "I hope that 'GF-103' will be used as a replacement or supplement drug to Eylea in future."

GenoFocus plans to prepare its first global clinical trial for 'GF-103' through BiomLogic, as it wants to focus only on the development of treatments for eye diseases. The company plans to submit IND application for AMD to the U.S. FDA within the latter half of this year. CEO Kim Yong-In of BiomLogic said, "We plans to complete the detailed design of Phase 1 Clinical Trial for dose escalation by April or May of the year."

In the meantime, GenoFocus, armed with enzyme and protein engineering technology and mass production technology, has already secured production processes and price competitiveness. GF Fermentech, a subsidiary specializing in bio-healthcare materials production, successfully attracted Series A investment of KRW 13 billion.