Due to the capacity of Nerve growth factor (NGF) to regulate the growth and survival of retinal and corneal cells, a recombinant form of NGF (Oxervate) has been approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the treatment of retinitis pigmentosa.
In addition, NGF performs important roles in neutrophils and neuroprotection, showing significant potential in the treatment of neurodegenerative diseases.
Application of Nerve Growth Factor (NGF)
Recombinant Human NGF for Oculopath
Developed by Dompé Farmaceutici, cenegermin (Oxervate) is a recombinant human nerve growth factor (NGF) formulation for the treatment of neurotrophic keratitis. Produced in Escherichia coli (E. coli), the recombinant NGF contains 118 amino acids and can enhance the survival of retina cells, while at the same time slowing down the worsening of the disease and preserving vision.
One NGF candidate (CHF6467) is a recombinant mutation form of human NGF with an amino acid substitution (R100E) developed by Chiesi Farmaceutici. The recombinant NGF protein is expressed in E. coli as inclusion bodies, followed by refolding, purification, and digestion to produce native NGF R100E. CHF6467 is being investigated in phase 2 clinical trial to evaluate its safety and efficacy in optic pathway glioma (OPG).
NGF gene for Alzheimer’s disease
At the same time, several properties of NGF including the high molecular weight, high polarity, and negative electrical charge make it hard to pass through the blood-brain barrier (BBB) to reach therapeutic targets. Adenoviral (e.g., AAV) and cell biodelivery-based delivery strategies are being studied.
Yaohai Bio-Pharma Offers One-Stop CDMO Solution for NGF
Nerve Growth Factor (NGF) Pipelines
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Generic Name
|
Brand Name/
Alternative Name
|
Expression System
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Indications
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Manufacturer
|
R&D Stage
|
|
Cenegermin-BKBJ
|
欧适维, cenegermin, Oxervate, recombinant human NGF, rhNGF, Sentinel
|
Escherichia coli
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Neurotrophic keratitis
|
Dompe Farmaceutici SpA
|
Approval
|
|
CHF-6467
|
Mutated hNGF
|
Escherichia coli
|
Neurotrophic keratitis, Optic Pathway Glioma
|
CHIESI Farmaceutici SpA
|
phase 2
|
|
ZX 1305
|
rhNGF
|
CHO cell
|
Neurotrophic keratitis
|
Xintrum Pharmaceuticals
|
phase 2
|
|
SMR001
|
rhNGF
|
CHO cell
|
Neurotrophic keratitis
|
Shandong Sinobioway Biomedicine
|
phase 2
|
|
rhNGF
|
Pending update
|
CHO cell
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Neurotrophic keratitis
|
Sichuan ZehaTimes Pharmaceutical
|
phase 2
|
|
HT006.2.2
|
rhNGF
|
Escherichia coli, Insect cell
|
Neurotrophic Keratitis
|
Wuhan Hiteck Biological Pharma
|
phase 1
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