Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD) and linked ocular disorders, today announced the presentation of preclinical data at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Virtual Annual Meeting, held May 1 to 7, 2021. The poster, titled “Anti-angiogenic activity of Complement Factor H in a laser-induced choroidal neovascularization mouse model,” demonstrated that human recombinant Complement Factor H (rhCFH) reduced the severity of CNV compared to control. GEM103 (rhCFH) is in clinical development as a potential therapy for patients with geographic atrophy (GA) secondary to dry AMD, as well as a potential add-on therapy for patients suffering from wet AMD with or at risk for macular atrophy (MA) who are receiving anti-vascular endothelial growth factor (anti-VEGF) treatment.
“We were pleased to see CNV severity was significantly reduced in the group treated with recombinant human CFH,” said Walter Strapps, Ph.D., Chief Scientific Officer of Gemini Therapeutics. “The results presented today demonstrate that GEM103 may be the next generation of complement therapeutics that is differentiated by both its mode of action and its potential for an improved safety profile. These data are part of the growing body of evidence contributing to our confidence in GEM103’s development as a novel intravitreal treatment to restore regulation of the complement system and potentially benefit patients with AMD.”
Results from this study in a laser-induced mouse model of wet AMD demonstrated that GEM103 reduced CNV severity comparable to aflibercept-treated control groups as measured by fluorescent angiography (FA) and optical coherence tomography (OCT). These observations suggest GEM103, absent a VEGF-enhancing moiety such as PEG, may not pose an increased risk of CNV development following intravitreal administration.
Gemini’s lead program, GEM103, is a pioneering precision medicine approach, targeting trial enrichment with genetically defined patients. GEM103 targets a genetically defined subset of age-related macular degeneration (AMD) patients with complement dysregulation. Of the 15 million dry AMD patients, approximately 40% (or six million) have variants in the complement factor H (CFH) gene. Such loss of function variants are associated with increased dry AMD disease risk. GEM103 is believed to be the first ever recombinant complement modulator and is a full-length and human, recombinant complement factor H (rCFH) protein. When delivered by intravitreal injection, GEM103 has the potential to address unmet medical need in genetically defined AMD patients by circumventing the complement dysfunction resulting from CFH loss of function variants and slowing the progression of their retina disease. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for GEM103 for the treatment of dry AMD in patients with CFH loss of function gene variants.
About Gemini Therapeutics
Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (AMD). Gemini’s lead candidate, GEM103, is a recombinant form of human complement factor H protein (CFH) and is designed to address both complement hyperactivity and restore retinal health in patients with AMD. GEM103 is currently in a Phase 2a trial in dry AMD patients with a CFH risk variant and a Phase 1/2a study in patients with neovascular age-related macular degeneration with or at risk for macular atrophy. The company has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies and is advancing a potentiating antibody for CFH, GEM307, into clinical development for treatment of systemic diseases.
For more information, visit www.geminitherapeutics.com.
Gemini’s Forward-Looking Statements
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Joshua R. Mansbach