Generx: SUMMARY COMMENTARY Generx will in
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Posted On: 07/09/2020 6:23:49 AM
Generx:
SUMMARY COMMENTARY
Generx [Ad5FGF-4] will initially be focused on refractory angina, which represents a significant
potentially unmet medical need for ~1.2 million U.S. patients with coronary artery disease, representing
a potential addressable market of > $3.0 billion. We believe FDA approval of Generx would be high
profile and garner significant worldwide interest.
In vitro studies identify FGF-4 as a key biologic regulatory protein that orchestrates the angiogenic
growth factor (e.g. VEGF)- mediated cascade of events required for therapeutic angiogenesis.
Preclinical studies confirmed and optimized Generx’s receptor-mediated uptake and level of transgene
expression in the heart, and demonstrated an angiogenic mechanism of action (echocardiography).
Human clinical studies confirmed Generx’s angiogenic mechanism of action, demonstrated increased
cardiac perfusion following a one-time treatment (SPECT imaging), and improvements in exercise
treadmill testing (ETT).
The FDA-approved Phase 3 AFFIRM study is designed statistically, based on prior Generx clinical study
data, to meet or exceed ETT outcomes that formed the basis for FDA approval of Ranexa.
Generx angiogenic therapy fits within the current standards of care (administered during a standard
angiography procedure), requires no special devices or training, and will be modestly priced to
maximize market adoption (aligned with stent pricing at $2k to $5k).
Novel anti-anginal therapies are few and far between. There has been only one anti-anginal drug with a
novel mechanism of action approved by the FDA in the past half-century (Gilead’s Ranexa), which was
acquired one year following FDA approval for $1.4 billion.
With FDA approval, Generx would be the first Gene Therapy for the treatment of “otherwise healthy
cardiac patients”, that would bring the field into mainstream cardiovascular medicine – an historic
achievement
SUMMARY COMMENTARY
Generx [Ad5FGF-4] will initially be focused on refractory angina, which represents a significant
potentially unmet medical need for ~1.2 million U.S. patients with coronary artery disease, representing
a potential addressable market of > $3.0 billion. We believe FDA approval of Generx would be high
profile and garner significant worldwide interest.
In vitro studies identify FGF-4 as a key biologic regulatory protein that orchestrates the angiogenic
growth factor (e.g. VEGF)- mediated cascade of events required for therapeutic angiogenesis.
Preclinical studies confirmed and optimized Generx’s receptor-mediated uptake and level of transgene
expression in the heart, and demonstrated an angiogenic mechanism of action (echocardiography).
Human clinical studies confirmed Generx’s angiogenic mechanism of action, demonstrated increased
cardiac perfusion following a one-time treatment (SPECT imaging), and improvements in exercise
treadmill testing (ETT).
The FDA-approved Phase 3 AFFIRM study is designed statistically, based on prior Generx clinical study
data, to meet or exceed ETT outcomes that formed the basis for FDA approval of Ranexa.
Generx angiogenic therapy fits within the current standards of care (administered during a standard
angiography procedure), requires no special devices or training, and will be modestly priced to
maximize market adoption (aligned with stent pricing at $2k to $5k).
Novel anti-anginal therapies are few and far between. There has been only one anti-anginal drug with a
novel mechanism of action approved by the FDA in the past half-century (Gilead’s Ranexa), which was
acquired one year following FDA approval for $1.4 billion.
With FDA approval, Generx would be the first Gene Therapy for the treatment of “otherwise healthy
cardiac patients”, that would bring the field into mainstream cardiovascular medicine – an historic
achievement
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