Delving into the Latest Updates on SGM-101 with Synapse

Overview

Basic Info

Drug Type

Antibody-photosensitizer conjugates

Synonyms

Target

CEA

Action

inhibitors

Mechanism

CEA inhibitors(Carcinoembryonic antigen inhibitors), Diagnostic dye

Therapeutic Areas

NeoplasmsDigestive System DisordersNervous System Diseases

Active Indication

Colorectal CancerGastrointestinal polypsBrain metastases+ [2]

Inactive Indication

Metastatic colon cancerSecondary malignant neoplasm of lung

Originator Organization

SurgiMab SAS

Active Organization

SurgiMab SAS

Academisch Ziekenhuis Leiden

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

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AbstractPurposeMetastasectomy is a common treatment option for patients with colorectal lung metastases (CLM). Challenges exist with margin assessment and identification of small nodules, especially during minimally invasive surgery. Intraoperative fluorescence imaging has the potential to overcome these challenges. The aim of this study was to assess feasibility of targeting CLM with the carcinoembryonic antigen (CEA) specific fluorescent tracer SGM-101.MethodsThis was a prospective, open-label feasibility study. The primary outcome was the number of CLM that showed a true positive fluorescence signal with SGM-101. Fluorescence positive signal was defined as a signal-to-background ratio (SBR) ≥ 1.5. A secondary endpoint was the CEA expression in the colorectal lung metastases, assessed with the immunohistochemistry, and scored by the total immunostaining score.ResultsThirteen patients were included in this study. Positive fluorescence signal with in vivo, back table, and closed-field bread loaf imaging was observed in 31%, 45%, and 94% of the tumors respectively. Median SBRs for the three imaging modalities were 1.00 (IQR: 1.00–1.53), 1.45 (IQR: 1.00–1.89), and 4.81 (IQR: 2.70–7.41). All tumor lesions had a maximum total immunostaining score for CEA expression of 12/12.ConclusionThis study demonstrated the potential of fluorescence imaging of CLM with SGM-101. CEA expression was observed in all tumors, and closed-field imaging showed excellent CEA specific targeting of the tracer to the tumor nodules. The full potential of SGM-101 for in vivo detection of the tracer can be achieved with improved minimal invasive imaging systems and optimal patient selection.Trial registrationThe study was registered in ClinicalTrial.gov under identifier NCT04737213 at February 2021.

01 Feb 2024·Journal of Biomedical Optics

Semi-automatic standardized analysis method to objectively evaluate near-infrared fluorescent dyes in image-guided surgery

Article

Author: Faber, Robin A ; Kuppen, Peter J K ; Galema, Hidde A ; Mieog, Jan Sven David ; Dijkstra, Jouke ; Linders, Daan G J ; Dijkhuis, Tom H ; Vahrmeijer, Alexander L ; Broersen, Alexander ; Bijlstra, Okker D ; Warmerdam, Mats I

SignificanceNear-infrared fluorescence imaging still lacks a standardized, objective method to evaluate fluorescent dye efficacy in oncological surgical applications. This results in difficulties in translation between preclinical to clinical studies with fluorescent dyes and in the reproduction of results between studies, which in turn hampers further clinical translation of novel fluorescent dyes.AimOur aim is to develop and evaluate a semi-automatic standardized method to objectively assess fluorescent signals in resected tissue.ApproachA standardized imaging procedure was designed and quantitative analysis methods were developed to evaluate non-targeted and tumor-targeted fluorescent dyes. The developed analysis methods included manual selection of region of interest (ROI) on white light images, automated fluorescence signal ROI selection, and automatic quantitative image analysis. The proposed analysis method was then compared with a conventional analysis method, where fluorescence signal ROIs were manually selected on fluorescence images. Dice similarity coefficients and intraclass correlation coefficients were calculated to determine the inter- and intraobserver variabilities of the ROI selections and the determined signal- and tumor-to-background ratios.ResultsThe proposed non-targeted fluorescent dyes analysis method showed statistically significantly improved variabilities after application on indocyanine green specimens. For specimens with the targeted dye SGM-101, the variability of the background ROI selection was statistically significantly improved by implementing the proposed method.ConclusionSemi-automatic methods for standardized quantitative analysis of fluorescence images were successfully developed and showed promising results to further improve the reproducibility and standardization of clinical studies evaluating fluorescent dyes.

01 Sep 2023·The Annals of Thoracic Surgery

Glycoprotein Receptor CEACAM5-Targeted Intraoperative Molecular Imaging Tracer in Non-Small Cell Lung Cancer

Article

Author: Chang, Ashley ; Singhal, Sunil ; Nadeem, Bilal ; Kucharczuk, John ; Azari, Feredun ; Kennedy, Gregory T ; Bernstein, Elizabeth ; Sullivan, Neil T ; Pèlegrin, André ; Cailler, Françoise

BACKGROUNDIntraoperative molecular imaging has emerged as a potential tool in addressing challenges faced during lung cancer surgery by localizing small lesions, ensuring negative margins, and identifying synchronous cancers. Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) glycoprotein has emerged as a potential target in fluorescent labeling of non-small cell lung cancer given the high antigen density in tumor cells and absence of expression in normal parenchyma. The goal of our study was to determine whether anti-CEACAM5 targeted near-infrared fluorochrome could be a suitable target in non-small cell lung cancer.METHODSThe CEACAM5 expression was evaluated in AB-12 (known negative control), HT29 (known positive control), and H460 (non-small cell lung cancer) cell lines by polymerase chain reaction. SGM-101, a CEACAM5 antibody, coupled with a BM-104 near-infrared fluorescent tracer was evaluated with dose escalation, in vitro cellular localization, and immunofluorescence microscopy. Subsequently, in vivo validation was performed in 52 athymic nude xenografts.RESULTSPolymerase chain reaction analysis demonstrated 3000x relative expression of CEACAM5 in HT-29 cells compared with AB-12. The H460 cells showed 1000x relative expression compared with AB12 (P < .05). Both HT29 and H460 cells showed tracer internalization with signal to background ratio of 4.5 (SD 0.34) whereas there was minimal uptake by AB12 cells with signal to background ratio 1.1 (SD 0.1; P < .05). There was linear fluorescence increase with increasing tracer dosing in receptor expressing cell lines. In preclinical models, HT-29 and H460 cells lines produced near-infrared fluorescence with average tumor to background ratio of 3.89 (SD 0.25) irrespective of tumor size compared with no fluorescence by AB12 tumors (P < .05). The CEACAM5 expressing tumors had excellent dye uptake compared with AB12 tumors.CONCLUSIONSCEACAM5 serves as a possible receptor for targeted intraoperative molecular imaging resections in lung cancer. This study sets a path for evaluation of CEACAM5 targets in future clinical trials.

100 Deals associated with SGM-101

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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 3	Netherlands	SurgiMab SAS	17 Jun 2019
Colorectal Cancer	Phase 3	Germany	SurgiMab SAS	17 Jun 2019
Colorectal Cancer	Phase 3	Italy	SurgiMab SAS	17 Jun 2019
Colorectal Cancer	Phase 3	United States	SurgiMab SAS	17 Jun 2019
Gastrointestinal polyps	Phase 2	Netherlands	Academisch Ziekenhuis Leiden	31 Jan 2024
Brain metastases	Phase 2	Netherlands	SurgiMab SAS	01 Jan 2024
Rectal Cancer	Phase 2	Netherlands	SurgiMab SAS	01 Jan 2024
Colorectal Liver Metastases	Phase 2	Netherlands	Academisch Ziekenhuis Leiden	01 Dec 2023
Metastatic colon cancer	Discovery	Netherlands	SurgiMab SAS	01 Nov 2020
Secondary malignant neoplasm of lung	Discovery	Netherlands	SurgiMab SAS	01 Nov 2020