Delving into the Latest Updates on Gallium-68 PSMA-617 with Synapse

Overview

Basic Info

Drug Type

Peptide Conjugate Radionuclide, Diagnostic radiopharmaceuticals

Synonyms

+ [3]

Target

PSMA

Action

inhibitors

Mechanism

PSMA inhibitors(Prostate-specific membrane antigen inhibitors)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Adenocarcinoma of prostateProstatic Cancer

Inactive Indication

Metastatic Prostate CarcinomaRecurrent Prostate Carcinoma

Originator Organization

Ruprecht-Karls-Universität Heidelberg

Active Organization

German Cancer Research Center

Ruprecht-Karls-Universität HeidelbergPeking Union Medical College Hospital

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2/3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC49H66GaN9O16

InChIKeyPAXMZYRHVDZFFV-VSVMWJISSA-I

CAS Registry2247839-19-4

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This project aims to monitor the innocuity/safety profile of cyclotron-produced [68Ga]-PSMA-617 PET imaging in PSMA-expressing cancers. It is a single-site, pragmatic, non-randomized and open-label study, with no control group. Although prostate cancers constitute the usual recommended population for this PET modality, recent evidences suggest that most solid tumors express substantial amount of PSMA in their neovasculature. As such, all cancers (excluding non-solid cancers) will be eligible for [68Ga]-PSMA-617 PET imaging in this trial, for as long as their tumors express PSMA.
This study also aims to instigate the use of [68Ga]-PSMA-617 in the routine standard-of-care for detection and follow-up of eligible cancers. FInally, this project seeks to gather information about the impact on patient management this novel PET modality will have over the current standard-of-care.

Start Date21 Jan 2022

Sponsor / Collaborator

Centre Hospitalier Universitaire de Sherbrooke

NCT05841992

/ RecruitingPhase 2/3IIT

Comparison of the Detection Efficiencies of Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT in Patients With Prostate Cancer

18F-labeled prostate-specific membrane antigen (PSMA) ligand-positron emission tomography (PET) offers advantages over 68Ga-labeled PSMA ligands. Al18F-PSMA-617 is a novel 18F-PSMA compound used for prostate cancer (PCa) imaging. This pilot study was prospectively designed to compare the lesion detectability of Al18F-PSMA-617 and related 68Ga-PSMA-617 PET/CT in patients with PCa

Start Date01 Jul 2021

Sponsor / Collaborator

Peking Union Medical College Hospital

100 Clinical Results associated with Gallium-68 PSMA-617

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100 Translational Medicine associated with Gallium-68 PSMA-617

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100 Patents (Medical) associated with Gallium-68 PSMA-617

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20

Literatures (Medical) associated with Gallium-68 PSMA-617

01 Sep 2024·Current Radiopharmaceuticals

“One Method to Label Them All”: A Single Fully Automated Protocol for GMP-Compliant ⁶⁸Ga Radiolabeling of PSMA-11, Transposable to PSMA-I&T and PSMA-617

Article

Author: Fersing, Cyril ; Fouillet, Juliette ; Deshayes, Emmanuel ; Rubira, Léa ; Donzé, Charlotte ; Santoro, Lore

Background::Prostate-specific membrane antigen (PSMA) is an ideal target for molecular imaging and targeted radionuclide therapy in prostate cancer. Consequently, various PSMA ligands were developed. Some of these molecules are functionalized with a chelator that can host radiometals, such as 68Ga for PET imaging. The 68Ga radiolabeling step benefits from process automation, making it more robust and reducing radiation exposure.Objective::To design a single automated radiolabeling protocol for the GMP-compliant preparation of [68Ga]Ga-PSMA-11, transposable to the production of [68Ga]Ga-PSMA-617 and [68Ga]Ga-PSMA-I&T.Methods::A GAIA® synthesis module and a GALLIAD® generator were used. Radio-TLC and radio-HPLC methods were validated for radiochemical purity (RCP) determination. Three [68Ga]Ga-PSMA-11 validation batches were produced and thoroughly tested for appearance and pH, radionuclide identity and purity, RCP, stability, residual solvent and sterility. Minimal modifications were made to the reagents and disposables for optimal application to other PSMA ligands.Results::[68Ga]Ga-PSMA-11 for clinical application was produced in 27 min. The 3 validation batches met the quality criteria expected by the European Pharmacopoeia to allow routine production. For optimal transposition to PSMA-617, the solid phase extraction cartridge was changed to improve purification of the radiolabeled product. For application to PSMA-I&T, the buffer solution initially used was replaced by HEPES 2.7 M to achieve good radiochemical yields. Residual HEPES content was checked in the final product and was below the Ph. Eur. threshold.Conclusion::A single automated radiolabeling method on the GAIA® module was developed and implemented for 68Ga radiolabeling of 3 PSMA ligands, with slight adjustments for each molecule.

23 Feb 2024·Journal of Leukocyte Biology

Construction of truncated PSMA as a PET reporter gene for CAR T cell trafficking

Article

Author: Long, Yu ; Lv, Xiaoying ; Xu, Zhuoshuo ; Zhang, Yirui ; Song, Xiangming ; Lan, Xiaoli ; Lei, Ping

AbstractIn solid tumors, there are multiple barriers for a chimeric antigen receptor (CAR) T cell to surmount in order to reach the tumor site. For better understanding whether CAR T cells effectively infiltrate into tumor site, and simultaneously, whether there are off-target effects, real-time monitoring technologies need to be established. Cell-based positron emission tomography reporter genes have been developed to monitor engineered cells in living subjects. In this study, we reported the construction of a novel reporter gene truncated prostate-specific membrane antigen (ΔPSMA) pending for monitoring CAR T cells using 68Ga-PSMA-617 and a method for tracking the distribution of CAR T cells in vivo was developed. Data were provided to demonstrate that ΔPSMA was predominantly localized on the plasma membrane and could take up 68Ga-PSMA-617 in vitro in a time-dependent manner. And the expression of ΔPSMA did not affect CAR expression and cytolytic capacity of CAR T cells. CAR-ΔPSMA T cell xenografts in nude mice were clearly imaged by positron emission tomography 60 min after injection of 68Ga-PSMA-617. PSMA paired with 68Ga-PSMA-617 was capable of identifying approximately 1 × 104 engineered CAR T cells. The ability to image small numbers of CAR T cells in vivo would be helpful to accelerate the translation of cell-based therapies into the clinic, and it may reinforce our understanding of treatment success, failure, and toxicity.

01 Jun 2023·European Journal of Nuclear Medicine and Molecular Imaging

A prospective comparative study of [68Ga]Ga-RM26 and [68Ga]Ga-PSMA-617 PET/CT imaging in suspicious prostate cancer

Article

Author: Hu, Shuo ; Gan, Yu ; Li, Jian ; Yin, Hongling ; Chen, Minfeng ; Gao, Xiaomei ; Cai, Yi ; Zu, Xiongbin ; Tang, Yongxiang

PURPOSEProstate-specific membrane antigen (PSMA)-based PET/CT imaging has limitations in the diagnosis of prostate cancer (PCa). We recruited 207 participants with suspicious PCa to perform PET/CT imaging with radiolabeled gastrin-releasing peptide receptor (GRPR) antagonist, [⁶⁸Ga]Ga-RM26, and compare with [⁶⁸Ga]Ga-PSMA-617 and histopathology.METHODSEvery participant with suspicious PCa was scanned with both [⁶⁸Ga]Ga-RM26 and [⁶⁸Ga]Ga-PSMA-617 PET/CT. PET/CT imaging was compared using pathologic specimens as a reference standard.RESULTSOf the 207 participants analyzed, 125 had cancer, and 82 were diagnosed with benign prostatic hyperplasia (BPH). The sensitivity and specificity of [⁶⁸Ga]Ga-RM26 and [⁶⁸Ga]Ga-PSMA-617 PET/CT imaging differed significantly for detecting clinically significant PCa. The area under the ROC curve (AUC) was 0.54 for [⁶⁸Ga]Ga-RM26 PET/CT and 0.91 for [⁶⁸Ga]Ga-PSMA-617 PET/CT in detecting PCa. For clinically significant PCa imaging, the AUCs were 0.51 vs. 0.93, respectively. [⁶⁸Ga]Ga-RM26 PET/CT imaging had higher sensitivity for PCa with Gleason score (GS) = 6 (p = 0.03) than [⁶⁸Ga]Ga-PSMA-617 PET/CT but poor specificity (20.73%). In the group with PSA < 10 ng/mL, the sensitivity, specificity, and AUC of [⁶⁸Ga]Ga-RM26 PET/CT were lower than [⁶⁸Ga]Ga-PSMA-617 PET/CT (60.00% vs. 80.30%, p = 0.12, 23.26% vs. 88.37%, p = 0.000, and 0.524 vs. 0.822, p = 0.000, respectively). [⁶⁸Ga]Ga-RM26 PET/CT exhibited significantly higher SUVmax in specimens with GS = 6 (p = 0.04) and in the low-risk group (p = 0.01), and its uptake did not increase with PSA level, GS, or clinical stage.CONCLUSIONThis prospective study provided evidence for the superior accuracy of [⁶⁸Ga]Ga-PSMA-617 PET/CT over [⁶⁸Ga]Ga-RM26 PET/CT in detecting more clinically significant PCa. [⁶⁸Ga]Ga-RM26 PET/CT showed an advantage for imaging low-risk PCa.

100 Deals associated with Gallium-68 PSMA-617

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	China	Peking Union Medical College Hospital	01 Oct 2020
Metastatic Prostate Carcinoma	IND Application	France	-	25 Apr 2018
Recurrent Prostate Carcinoma	IND Application	France	-	25 Apr 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EANM2024	Not Applicable	Prostatic Cancer	38	Ga-PSMA-617 (mpMRI)	akqwuaidel(ciqrodekrb) = banuvlrsti necvtaqhyg (urrxbkzkvq )	-	27 Sep 2024
EANM2024	Not Applicable	Prostatic Cancer	38	Ga-PSMA-617 (68Ga-RM26 PET)	akqwuaidel(ciqrodekrb) = czkzffqaib necvtaqhyg (urrxbkzkvq )	-	27 Sep 2024
SNMMI2020	Not Applicable	-	-	68Ga-PSMA-617	ynmkvzmohv(emnoiwvoyx) = xdyqbildfn amwskpzxtb (idzzlaxald ) View more	-	15 May 2020
SNMMI2020	Not Applicable	-	-	68 Ga-PSMA-61768Ga-PSMA-617 (Cyclotron-produced 68Ga-PSMA-617)	eexbsbjnyj(qkgwkkkaxd) = >95% eyaukeojbp (fzyzuaqmfm ) View more	-	15 May 2020

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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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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