Delving into the Latest Updates on hI-con1 with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Immuno-conjugate-1, human Immuno-conjugate 1

+ [1]

Target

tissue factor

Action

inhibitors

Mechanism

tissue factor inhibitors(Tissue factor inhibitors)

Therapeutic Areas

Congenital DisordersEye Diseases

Active Indication

Dystrophy, Macular

Inactive Indication

Originator Organization

Yale University

Active Organization

Iconic AS

Yale University

Inactive Organization

Iconic Therapeutics, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 13031459

The purpose of this study is to evaluate the safety, tolerability, biological activity, pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo enucleation or brachytherapy of the affected eye.

Start Date01 May 2016

Sponsor / Collaborator

Iconic Therapeutics, Inc.

NCT02358889

/ CompletedPhase 2

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

The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Start Date01 Feb 2015

Sponsor / Collaborator

Iconic Therapeutics, Inc.

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-con1

01 May 2020·Asia-Pacific Journal of OphthalmologyQ4 · MEDICINE

Emerging Therapies in Neovascular Age-Related Macular Degeneration in 2020

Q4 · MEDICINE

ReviewOA

Author: Chhablani, Jay ; Khanani, Arshad M ; Singh, Sumit Randhir ; Jhingan, Mahima ; Aziz, Aamir A ; Samanta, Anindya

AbstractAge-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 2018·Ophthalmic Surgery, Lasers and 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: Victor H. Gonzalez ; Brian B. Berger ; Brian D. Sippy ; Christine R. Gonzales ; John A. Wells ; Gabriela Burian

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 2017·Investigative Opthalmology & Visual ScienceQ2 · MEDICINE

A Pharmacodynamic Analysis of Choroidal Neovascularization in a Porcine Model Using Three Targeted Drugs

Q2 · MEDICINE

ArticleOA

Author: Tran, Jeffrey ; Grossniklaus, Hans E. ; Kompella, Uday ; Wabner, Kathy ; Olsen, Timothy W. ; Matter, Brock ; Schmit, Jenn ; Craven, Caroline

PurposeTo 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.MethodsForty-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.ResultsIn 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.ConclusionsIntravitreal 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.

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Indication	Highest Phase	Country/Location	Organization	Date
Dystrophy, Macular	Phase 2	-	Iconic AS	-
Dystrophy, Macular	Phase 2	-	Yale University	-
Wet Macular Degeneration	Phase 1	United States	Iconic Therapeutics, Inc.	26 Mar 2018
Choroid Neoplasms	Phase 1	United States	Iconic Therapeutics, Inc.	01 May 2016
Uveal Melanoma	Phase 1	United States	Iconic Therapeutics, Inc.	01 May 2016
Age Related Macular Degeneration	Phase 1	United States	Iconic Therapeutics, Inc.	01 Feb 2015
Choroidal Neovascularization	Phase 1	United States	Iconic Therapeutics, Inc.	01 Feb 2015
Wet age-related macular degeneration	Phase 1	United States	Iconic Therapeutics, Inc.	01 Dec 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03452527 (DECO, CTgov)	Phase 2	Choroidal Neovascularization \| Age Related Macular Degeneration \| Wet Macular Degeneration	15	aflibercept+ICON-1 (ICON-1 Maintenance Therapy)	apcvtizzkg(blorrsowqn) = ikyefmbqyy psqtzqbbnc (sfdvyvtzni, puwjzdsjoc - eodjlzgnxp) View more	-	15 Mar 2021
				aflibercept+ICON-1 (ICON-1 Combination Therapy)	apcvtizzkg(blorrsowqn) = flbluebtek psqtzqbbnc (sfdvyvtzni, otukchswvs - pfwwsgwery) View more
NCT01485588 (Phase 1 Clinical Trial Targeting Tissue Factor, CTgov)	Phase 1/2	Wet age-related macular degeneration	18	hI-con1™ 300µl	edzuqkfutz(kdfucfkaff) = eisvfxygbu vpmywrxoso (rgiqpveeux, fdixlanvtr - mepnrtfriz)	-	06 Nov 2020
NCT02358889 (EMERGE, CTgov)	Phase 2	Choroidal Neovascularization \| Age Related Macular Degeneration	88	Sham injection+hI-con1 (hI-con1)	ntidsgsgyv(epvtufmayl) = dyuqifydnx assrxynxbx (zcerwzrtjy, cymimaqhgz - akpjxxccmf) View more	-	24 Sep 2020
				ranibizumab+hI-con1 (hI-con1 + Ranibizumab)	ntidsgsgyv(epvtufmayl) = heianjdabx assrxynxbx (zcerwzrtjy, pydpgltfnw - kwgdtpcrsk) View more
NCT02771340 (CTgov)	Phase 1	Uveal Melanoma \| Choroid Neoplasms	10	ICON-1 (ICON-1 0.3 mg Singe Dose)	xxijgmdxnx(ngffumckdj) = ujjicdvpee zdscvpcqnn (iocefdniqv, fmuhisqzux - yczvcianqb) View more	-	14 Sep 2020
				ICON-1 (ICON-1 0.3 mg Repeat Dosing)	xxijgmdxnx(ngffumckdj) = wzdakwgysu zdscvpcqnn (iocefdniqv, bheoitwxfv - nytxtyelnf) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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