Gemini Therapeutics Announces Presentation of Preclinical Data at 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
Gemini Therapeutics, Inc. (Nasdaq: GMTX) has presented preclinical data at the 2021 ARVO Virtual Annual Meeting, illustrating that their lead candidate GEM103 demonstrates anti-angiogenic activity in a mouse model for age-related macular degeneration (AMD). The use of human recombinant Complement Factor H (rhCFH) significantly diminished choroidal neovascularization (CNV) severity. GEM103 aims to treat genetically defined dry AMD patients and is currently undergoing clinical trials, with Fast Track Designation from the FDA for patients with CFH loss of function variants.
- GEM103 significantly reduced CNV severity in a preclinical model, comparable to aflibercept controls.
- FDA granted Fast Track Designation for GEM103 for dry AMD treatment in patients with CFH gene variants.
- GEM103 represents a novel therapeutic approach targeting genetically defined AMD patients.
- None.
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.
About GEM103
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
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
Certain statements in this press release and the information incorporated herein by reference may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, cost and timing of our product development activities and clinical trials, including our estimates regarding when data will be reported from ongoing clinical trials and the timing to commence future clinical trials, the potential attributes and benefits of our product candidates, including GEM103, our ability to obtain and maintain regulatory approval for our product candidates, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the final proxy/prospectus for our recently completed business combination, and those that are included in any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
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