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IGF-1

IGF-1

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IGF-1

Insulin-like growth factor-1 (IGF-1), formerly known as somatostatin C, is a single-chain peptide consisting of 70 amino acids with three disulfide bridges. IGF1 is the major mediator of prenatal and postnatal growth, which regulates normal growth during childhood also exerts potent anabolic effects in adults.

Recombinant IGF-1 is licensed for the treatment of growth retardation in children with severe primary IGF-I deficiency (SPIGFD).

IGF-1 for Therapeutic Use
Recombinant human IGF-1, rhIGF-1

Mecacermin, a recombinant human IGF-1 (rhIGF-1), has been approved by the U.S. FDA to treat pediatric patients with postnatal growth failure and severe primary IGF-1 deficiency or growth hormone (GH) deficiency. The active ingredient of Mecasermin consists of 70 amino acids (~7.6 kDa), which is identical to endogenous human IGF-1.

The rhIGF-1 protein is produced in a bacteria system Escherichia coli (E. coli).

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Figure 1. Structure formula of recombinant human IGF-1

R3 IGF-1

R3 IGF-I is a more biologically active hIGF-1 analogue that contains the complete amino acid sequence of human IGF-I with Glu3 (E3) replaced by Arg3 (R3), and a 13 amino acid stretch peptide at the N-terminus.

hIGF-1 Fusion Protein

Several clinical trials have been conducted with hIGF-1 conjugated or fused proteins, like IGF1-IGFBP3 (SHP607) for the prevention of chronic lung disease in preterm infants; vitronectin-IGF1 (VF001-DP) for the cure of chronic venous leg ulcers; IGF1-annexin A5 (SCP -776) used to treat congestive heart failure and acute ischemic stroke; IGF-MTX conjugate for the treatment of myelodysplastic syndromes.

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for IGF-1
Approved Recombinant IGF-1

Generic name

Brand Name/Altermative name

Expression System

Indications

Manufacturer

R&D Stage

Mecasermin

FK780, Somazon

E. coli

LeprechaunismLaron syndromeRabson-Mendenhall syndromeCongenital generalized lipodystrophy

Astellas Pharma, Fujisawa Pharmaceutical

Approval

IGF-1

Igef

Pending Update

Dwarfism

Biogen, Inc.、Pharmacia & Upjohn, Inc.

Approval

Mecasermin biosimilar

Mecasermin (Ipsen)、rhIGF-I、Increlex、IGF-1 (Ipsen)、Somatomedin-1 (Ipsen)、Insulin-like growth factor-1 (Ipsen)、MKN-031

E. coli

DwarfismLaron syndromeincomplete growthgrowth hormone deficiencyInsulin-like growth factor I deficiency

Ipsen SA

Approved

Mecasermin biosimilar

Myotrophin, CEP-120, KW-6151

Pending Update

Amyotrophic Lateral SclerosisLou Gehrig’s disease

Cephalo, MSD

Failed to be approved

Mecasermin Rinfabate Recombinant,IPLEX

Mecasermin Rinfabate, SomatoKine, Premiplex, IPLEX, HGT-ROP-001, SHP-607, TAK 607, IGF-I/IGFBP-3

E. coli

Bronchopulmonary dysplasiaintraventricular hemorrhageLung diseaseRetinopathy of prematurity

Insmed,Takeda Pharmaceutical, Shire Plc

Phase II

Vitronectin-IGF-1 fusion protein

VF-001-DP-LD, VF001, VF 001, VitroGro

Yeast

Lower limb ulcersEye diseasesDiabetic foot

Dominion Minerals Ltd.

Phase II

Scp-776

Annexin A5-serum albumin-IGF-1 fusion protein

Pending Update

ischemic stroke

Silver Creek

Phase II

IGF-methotrexate conjugate

IGF-MTX Conjugated drugs, 765IGFMTX, Single domain antibody-Fc

E. coli

myeloid leukemiaMyelodysplastic syndrome

IGF Oncology

Phase I&II

MHB018A

Single domain antibody-Fc

Pending Update

Graves' ophthalmopathy

Minghui Pharmaceutical (Hangzhou) Co., Ltd.

Phase I

Insulin-Like Growth Factor 1

Pending Update

Pending Update

Nasolabial folds, sunburn

Wright State Physicians, Inc.

Phase I

MOD-13012

CTP-IGF-1 fusion protein, sustained-release IGF-1

Pending Update

Insulin-like growth factor I deficiency

OPKO Biologics (formerly Prolor Biotech),

Phase I

KT-A832

AAV-IGF1 - Kriya Therapeutics, KT-A832

Pending Update

type 1 diabetes

Kriya Therapeutics, Inc.

Pre-clinical

Chondrokin

Antibody fusion protein, IGF1-C11

Pending Update

Osteoarthritis

Philogen SpA

Pre-clinical

AZP-3404

Peptide, 9-peptide, IGFPB2

Pending Update

Insulin resistanceobesity

Millendo Therapeutics SAS, Amolyt Pharma SAS

Pre-clinical

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