Delving into the Latest Updates on EMI-137 with Synapse

Overview

Basic Info

Drug Type

Fluorescent Peptide

Synonyms

Target

c-Met

Action

modulators

Mechanism

c-Met modulators(Hepatocyte growth factor receptor modulators)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Colorectal Cancer

Inactive Indication

Barrett EsophagusBreast CancerColonic Cancer+ [8]

Originator Organization

GE Healthcare, Inc.

Active Organization

GE Healthcare, Inc.

Inactive Organization

Netherlands Cancer Insitute

Edinburgh Molecular Imaging Ltd.

University Medical Center of Utrecht

License Organization

Dyax Corp.GE Healthcare, Inc.

Edinburgh Molecular Imaging Ltd.

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Structure/Sequence

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Sequence Code 1277664502

Source: *****

EMI-137 in laparoscopic colonic resections is a single-centre stage IIa developmental study.
Ten adult participants with a diagnosis of colon adenocarcinoma undergoing laparoscopic colonic will be recruited to the trial. Participants will receive a single intravenous dose of the IMP - EMI-137 1 to 3 hours before surgery. The ability of EMI-137 to produce visible intra-operative fluorescence of primary colon cancer and lymph node metastases will be explored and evaluated.

Start Date14 Feb 2018

Sponsor / Collaborator

University of Leeds

[+1]

EUCTR2016-003128-22-GB

/ Not yet recruitingPhase 2IIT

Intraoperative imaging of colon cancer using a fluorescent peptide (EMI-137) against the c-Met receptor

Start Date19 Oct 2017

Sponsor / Collaborator

University of Leeds

100 Clinical Results associated with EMI-137

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100 Translational Medicine associated with EMI-137

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100 Patents (Medical) associated with EMI-137

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9

Literatures (Medical) associated with EMI-137

01 Jul 2024·European Journal of Nuclear Medicine and Molecular Imaging

MET-receptor targeted fluorescent imaging and spectroscopy to detect multifocal papillary thyroid cancer.

Article

Author: Kruijff, Schelto ; Sondorp, Luc H J ; Links, Thera P ; Nguyen, Anh H ; van Diest, Paul J ; Metman, Madelon J H ; van Dam, Gooitzen M ; Gill, Anthony J ; Jansen, Liesbeth ; Löwik, Clemens W G M ; Sywak, Mark S ; van Hemel, Bettien M ; van Ginhoven, Tessa M ; Coppes, Rob P ; Jonker, Pascal K C ; Fehrmann, Rudolf S N ; Robinson, Dominic J

AbstractPurposeMultifocal disease in PTC is associated with an increased recurrence rate. Multifocal disease (MD) is underdiagnosed with the current gold standard of pre-operative ultrasound staging. Here, we evaluate the use of EMI-137 targeted molecular fluorescence-guided imaging (MFGI) and spectroscopy as a tool for the intra-operative detection of uni- and multifocal papillary thyroid cancer (PTC) aiming to improve disease staging and treatment selection.MethodsA phase-1 study (NCT03470259) with EMI-137 was conducted to evaluate the possibility of detecting PTC using MFGI and quantitative fiber-optic spectroscopy.ResultsFourteen patients underwent hemi- or total thyroidectomy (TTX) after administration of 0.09 mg/kg (n = 1), 0.13 mg/kg (n = 8), or 0.18 mg/kg (n = 5) EMI-137. Both MFGI and spectroscopy could differentiate PTC from healthy thyroid tissue after administration of EMI-137, which binds selectively to MET in PTC. 0.13 mg/kg was the lowest dosage EMI-137 that allowed for differentiation between PTC and healthy thyroid tissue. The smallest PTC focus detected by MFGI was 1.4 mm. MFGI restaged 80% of patients from unifocal to multifocal PTC compared to ultrasound.ConclusionEMI-137-guided MFGI and spectroscopy can be used to detect multifocal PTC. This may improve disease staging and treatment selection between hemi- and total thyroidectomy by better differentiation between unifocal and multifocal disease.Trial registration

NCT03470259

01 Aug 2022·European Journal of Nuclear Medicine and Molecular Imaging

Intraoperative MET-receptor targeted fluorescent imaging and spectroscopy for lymph node detection in papillary thyroid cancer: novel diagnostic tools for more selective central lymph node compartment dissection

Article

Author: van Hemel, Bettien M ; Links, Thera P ; Sondorp, Luc H J ; Coppes, Robert P ; Metman, Madelon J H ; Nguyen, Anh H ; Gill, Anthony J ; van Diest, Paul J ; Jonker, Pascal K C ; Löwik, Clemens W G M ; van Ginhoven, Tessa M ; Jansen, Liesbeth ; Fehrmann, Rudolf S N ; van Dam, Gooitzen M ; Sywak, Mark S ; Kruijff, Schelto ; Robinson, Dominic J

Abstract PurposePatients undergoing prophylactic central compartment dissection (PCLND) for papillary thyroid cancer (PTC) are often overtreated. This study aimed to determine if molecular fluorescence-guided imaging (MFGI) and spectroscopy can be useful for detecting PTC nodal metastases (NM) and to identify negative central compartments intraoperatively.MethodsWe used a data-driven prioritization strategy based on transcriptomic profiles of 97 primary PTCs and 80 normal thyroid tissues (NTT) to identify tumor-specific antigens for a clinically available near-infrared fluorescent tracer. Protein expression of the top prioritized antigen was immunohistochemically validated with a tissue microarray containing primary PTC (n = 741) and NTT (n = 108). Staining intensity was correlated with 10-year locoregional recurrence-free survival (LRFS). A phase 1 study (NCT03470259) with EMI-137, targeting MET, was conducted to evaluate safety, optimal dosage for detecting PTC NM with MFGI, feasibility of NM detection with quantitative fiber-optic spectroscopy, and selective binding of EMI-137 for MET.ResultsMET was selected as the most promising antigen. A worse LRFS was observed in patients with positive versus negative MET staining (81.9% versus 93.2%; p = 0.02). In 19 patients, no adverse events related to EMI-137 occurred. 0.13 mg/kg EMI-137 was selected as optimal dosage for differentiating NM from normal lymph nodes using MFGI (p < 0.0001) and spectroscopy (p < 0.0001). MFGI identified 5/19 levels (26.3%) without NM. EMI-137 binds selectively to MET.ConclusionMET is overexpressed in PTC and associated with increased locoregional recurrence rates. Perioperative administration of EMI-137 is safe and facilitates NM detection using MFGI and spectroscopy, potentially reducing the number of negative PCLNDs with more than 25%.Clinical trial registration.NCT03470259.

01 Mar 2022·Surgical OncologyQ3 · MEDICINE

A novel fluorescent c-met targeted imaging agent for intra-operative colonic tumour mapping: Translation from the laboratory into a clinical trial

Q3 · MEDICINE

Article

Author: Nick P. West ; Gemma R. Armstrong ; David G. Jayne ; Christophe Portal ; Mohammed I. Khot ; Damian J. Tolan ; Thomas A. Hughes ; Sarah L. Perry ; Tom I. Maisey ; Jim P. Tiernan

BACKGROUNDThe c-Met protein is overexpressed in many gastrointestinal cancers. We explored EMI-137, a novel c-Met targeting fluorescent probe, for application in fluorescence-guided colon surgery, in HT-29 colorectal cancer (CRC) cell line and an in vivo murine model.METHODSHT-29 SiRNA transfection confirmed specificity of EMI-137 for c-Met. A HT-29 CRC xenograft model was developed in BALB/c mice, EMI-137 was injected and biodistribution analysed through in vivo fluorescent imaging. Nine patients, received a single intravenous EMI-137 bolus (0.13 mg/kg), 1-3 h before laparoscopic-assisted colon cancer surgery (NCT03360461). Tumour and LN fluorescence was assessed intraoperatively and correlated with c-Met expression in eight samples by immunohistochemistry.FINDINGSc-Met expression HT-29 cells was silenced and imaged with EMI-137. Strong EMI-137 uptake in tumour xenografts was observed up to 6 h post-administration. At clinical trial, no serious adverse events related to EMI-137 were reported. Marked background fluorescence was observed in all participants, 4/9 showed increased tumour fluorescence over background; 5/9 had histological LN metastases; no fluorescent LN were detected intraoperatively. All primary tumours (8/8) and malignant LN (15/15) exhibited high c-Met protein expression.INTERPRETATIONEMI-137, binds specifically to the human c-Met protein, is safe, and with further refinement, shows potential for application in fluorescence-guided surgery.

100 Deals associated with EMI-137

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Cancer	Phase 2	-	GE Healthcare, Inc.	16 Sep 2015
Penile Neoplasms	Discovery	Netherlands	Netherlands Cancer Insitute	12 Oct 2019
Tongue Neoplasms	Discovery	Netherlands	Netherlands Cancer Insitute	11 Oct 2019
Ovarian Cancer	Discovery	United Kingdom	Edinburgh Molecular Imaging Ltd.	09 Sep 2019
Prostatic Cancer	Discovery	United Kingdom	Edinburgh Molecular Imaging Ltd.	09 Sep 2019
Colonic Cancer	Discovery	United Kingdom	Edinburgh Molecular Imaging Ltd.	14 Feb 2018
Lymphatic Metastasis	Discovery	United Kingdom	Edinburgh Molecular Imaging Ltd.	14 Feb 2018
Breast Cancer	Discovery	United Kingdom	-	13 Nov 2015
Barrett Esophagus	Discovery	Netherlands	University Medical Center of Utrecht	-
Thyroid Cancer	Discovery	Netherlands	Edinburgh Molecular Imaging Ltd.	-

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Approval

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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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EMI-137

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation