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Last update 16 May 2025
hI-con1
Last update 16 May 2025
Overview
Basic Info
Drug Type Fc fusion protein |
Synonyms human Immuno-conjugate 1, Immuno-conjugate-1, HICON1 + [1] |
Target |
Action inhibitors |
Mechanism tissue factor inhibitors(Tissue factor inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhasePhase 2 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Sequence Code 13031459
Related
4
Clinical Trials associated with hI-con1NCT03452527
A Phase 2 Randomized, Open-Label, Multicenter Study Evaluating Administration of Repeated Intravitreal Doses of ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
NCT02771340
A Phase 1, Open-label, Multicenter Study Evaluating the Safety and Tolerability, Biologic Activity, Pharmacodynamics, and Pharmacokinetics of Single and Repeated Escalating Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Who Are Planned to Undergo Enucleation or Brachytherapy
NCT02358889
A Phase 2 Randomized, Double-masked, Multicenter, Active-controlled Study Evaluating Administration of Repeated Intravitreal Doses of hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
100 Clinical Results associated with hI-con1
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100 Translational Medicine associated with hI-con1
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100 Patents (Medical) associated with hI-con1
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8
Literatures (Medical) associated with hI-con101 May 2020Asia-Pacific journal of ophthalmology (Philadelphia, Pa.)Q4 · MEDICINE
Emerging Therapies in Neovascular Age-Related Macular Degeneration in 2020
Q4 · MEDICINE
ReviewOA
Author: Khanani, Arshad M ; Aziz, Aamir A ; Samanta, Anindya ; Singh, Sumit Randhir ; Jhingan, Mahima ; Chhablani, Jay
Abstract:
Age-related macular degeneration (AMD) is one of the most common causes of vision loss. Advanced forms of AMD are seen in primarily 2 types—neovascular AMD (nAMD) with the presence of choroid neovascularization and nonneovascular AMD (nnAMD) with geographic atrophy. Although there are 4 anti-vascular endothelial growth factor drugs either widely used or approved for the former, there are no current treatments for the latter. This review will highlight upcoming treatments for AMD currently in clinical trials. For nAMD: Abicipar pegol, an intravitreal anti-vascular endothelial growth factor based on designed ankyrin repeat proteins (DARPins) is currently pending approval. Conbercept and Faricimab, 2 intravitreal anti-growth factors, are currently in phase 3. Nine other upcoming agents have at least produced results in the 1B/2A phase including intravitreal injections (KSI-301, OPT-302, RGX-314, ICON-1, and DE-122), depot (GB-102), drug reservoir (PDS), topical drops (PAN-90806), and oral formulations (AKST4290). We summarize all the newer molecules.
01 May 2018Ophthalmic surgery, lasers & imaging retinaQ4 · MEDICINE
A Phase 1, Open-Label, Dose-Escalation Trial to Investigate Safety and Tolerability of Single Intravitreous Injections of ICON-1 Targeting Tissue Factor in Wet AMD
Q4 · MEDICINE
Article
Author: Brian D. Sippy ; Brian B. Berger ; Gabriela Burian ; John A. Wells ; Christine R. Gonzales ; Victor H. Gonzalez
BACKGROUND AND OBJECTIVE::
This phase 1 study evaluated the safety and tolerability of single intravitreous injections (IVIs) of ICON-1 (Iconic Therapeutics, South San Francisco, CA) in patients with neovascular age-related macular degeneration (nAMD). ICON-1 is a modified factor VIIa protein linked with the Fc portion of a human immunoglobulin G1. The molecule binds tissue factor overexpressed on choroidal neovascularization (CNV) in AMD.
PATIENTS AND METHODS::
Open-label, interventional, dose-escalation trial in 18 patients with CNV due to AMD, with six patients per dose cohort. Patients received a single IVI of ICON-1 at baseline in one of three escalating doses: 60 μg, 150 μg, or 300 μg. Standard anti-vascular endothelial growth factor treatment was allowed at the investigator's discretion at least 2 weeks after the ICON-1 injection; patients were followed up to 24 weeks. Dose escalation was based on the absence of significant safety events. At each study visit, best-corrected visual acuity (BCVA), ophthalmic examination (intraocular pressure, slit-lamp, and dilated fundus examination), and ophthalmic imaging (color fundus photography, fluorescein angiography, and optical coherence tomography) assessments were performed. The systemic pharmacokinetics of ICON-1 and presence of anti-ICON-1 antibodies were also assessed.
RESULTS::
ICON-1 was safe and well-tolerated up to the highest dose administered, which was 300 μg. Commonly reported adverse events were considered related to the IVI procedure or to the underlying nAMD. No significant systemic levels of ICON-1 or anti-ICON-1 antibodies were detected. Preliminary evidence of biological activity (improved BCVA, reduced central retinal thickness, decreased CNV size, and leakage) was most evident with the 300 μg dose at 1 to 2 weeks after the single ICON-1 injection.
CONCLUSION::
Intravitreous administration of ICON-1 in single doses up to 300 μg in eyes with neovascular AMD was safe and well-tolerated.
[
Ophthalmic Surg Lasers Imaging Retina
. 2018;49:336–345.]
24 Jul 2017Investigative ophthalmology & visual scienceQ2 · MEDICINE
A Pharmacodynamic Analysis of Choroidal Neovascularization in a Porcine Model Using Three Targeted Drugs
Q2 · MEDICINE
ArticleOA
Author: Matter, Brock ; Schmit, Jenn ; Craven, Caroline ; Wabner, Kathy ; Tran, Jeffrey ; Grossniklaus, Hans E. ; Olsen, Timothy W. ; Kompella, Uday
Purpose:
To compare the efficacy of microneedle-delivered suprachoroidal (SC) pazopanib to intravitreal (Ivit) delivery of pazopanib, bevacizumab, or a fusion protein hI-con1 versus vehicle controls on choroidal neovascularization (CNV) growth in a pig model.
Methods:
Forty-one pigs were injected on the day of CNV induction (hI-con1 on postinduction day 14) with either 2.5 mg Ivit bevacizumab (n = 9), 1 mg Ivit pazopanib (n = 9), 300 Ivit μg hI-con1 (n = 4), or 1 mg SC pazopanib (n = 9), vs. 10 vehicle controls (3 SC + 7 Ivit = 10). Pigs were euthanized at week 2 (11), 3 (8), 4 (11), and 8 (11), and eyes were fixed for histology. The size of the CNV was determined from histology, and CNV height was the primary outcome measure. Immunostaining for cytotoxic T-cells was performed in the hI-con1 study.
Results:
In 39 of 41 (95%) eyes, type 2 CNV lesions were identified. One CNV lesion was lost during dissection. One animal was euthanized due to surgical complications. For mean CNV size comparisons, Ivit pazopanib had smaller mean height measurements (90 ± 20 μm) versus controls (180 ± 20 μm; P = 0.009), and Ivit pazopanib had smaller maximum CNV height (173 ± 43 μm) compared to SC pazopanib (478 ± 105 μm; P = 0.018). The mean lesion size in hI-con1-treated animals trended smaller than in controls (P = 0.11). Immunostaining did not detect cytotoxic T-cells.
Conclusions:
Intravitreal pazopanib and to a lesser extent hI-con1 reduced the size of CNV lesions. The pig model has nearly a 100% rate of type 2 CNV induction and is a reliable preclinical model with pharmacodynamics similar to humans.
100 Deals associated with hI-con1
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Wet Macular Degeneration | Phase 2 | United States | 26 Mar 2018 | |
| Age Related Macular Degeneration | Phase 2 | United States | 01 Feb 2015 | |
| Choroidal Neovascularization | Phase 2 | United States | 01 Feb 2015 | |
| Wet age-related macular degeneration | Phase 2 | United States | 01 Dec 2010 | |
| Dystrophy, Macular | Phase 2 | - | - | |
| Dystrophy, Macular | Phase 2 | - | - | |
| Choroid Neoplasms | Phase 1 | United States | 01 May 2016 | |
| Uveal Melanoma | Phase 1 | United States | 01 May 2016 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 2 | 15 | aflibercept+ICON-1 (ICON-1 Maintenance Therapy) | dntvjlrnud = vlmszksggx ytviannblh (nuqpbuadfg, hhhdavecaw - abnzswapud) View more | - | 15 Mar 2021 | ||
aflibercept+ICON-1 (ICON-1 Combination Therapy) | dntvjlrnud = oxemnezves ytviannblh (nuqpbuadfg, sdcolvsqav - uerfqbzdwr) View more | ||||||
Phase 1/2 | 18 | mmatrjikke(tyfopjzazz) = hvnqttppwq sqxfysqrmj (vqwavvfqqc, 5.03) | - | 06 Nov 2020 | |||
Phase 2 | 88 | Sham injection+hI-con1 (hI-con1) | tpbjodkfot(avfmmcabhb) = buagaaalsk lntepjvywx (vjnbewlzfd, 7.76) View more | - | 24 Sep 2020 | ||
ranibizumab+hI-con1 (hI-con1 + Ranibizumab) | tpbjodkfot(avfmmcabhb) = tuubccxjzk lntepjvywx (vjnbewlzfd, 8.21) View more | ||||||
Phase 1 | 10 | (ICON-1 0.3 mg Singe Dose) | bfcxvcskbm = dmxrcpktts yduljxexno (acnwszjrma, dmunfhccmk - rckeftkyyp) View more | - | 14 Sep 2020 | ||
(ICON-1 0.3 mg Repeat Dosing) | bfcxvcskbm = ebcigwjawt yduljxexno (acnwszjrma, tqafcglaht - hebqnugjay) View more |
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