Gemini Therapeutics Announces Presentation of Preclinical Data at 2021 Association for Research in Vision & Ophthalmology (AR...
May 01 2021 - 7:00AM
Business Wire
− GEM103 demonstrates anti-angiogenic activity
in a mouse model of laser-induced choroidal neovascularization
(CNV)
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
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
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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version on businesswire.com: https://www.businesswire.com/news/home/20210501005002/en/
Investor Contact: Argot Partners Sherri Spear
212-600-1902 gemini@argotpartners.com
Media Contact: Argot Partners Joshua R. Mansbach
212-600-1902 gemini@argotpartners.com
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