Delving into the Latest Updates on 64Cu-DOTA-AE105 with Synapse

Overview

Basic Info

Drug Type

Diagnostic radiopharmaceuticals, Radionuclide Drug Conjugates (RDC)

Synonyms

64Cu-DOTA-AE105

Target

uPAR

Action

inhibitors

Mechanism

uPAR inhibitors(Urokinase plasminogen activator surface receptor inhibitors)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Adenocarcinoma of prostateLocalized Prostate CarcinomaNeoplasms

Inactive Indication-

Originator Organization

Active Organization

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

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The goal of this clinical trial is to test if the experimental agent accurately determines the aggressiveness of prostate cancer (biopsy-verified ISUP grade). The aim is that the diagnostic PET imaging agent may be used as an alternative or supplement to biopsies in the monitoring of patients with low-risk prostate cancer in active surveillance.
Patients diagnosed with untreated, low-grade, localized prostate cancer may participate in the trial. The experimental diagnostic agent 64Cu-DOTA-AE105 is a radiopharmaceutical which is injected into the veins and binds to uPAR expressing cells in the tumour which can then be visualized in a PET scanner.
The main question the trial aims to answer is: Can the test drug be used alone or as a supplement to repeated biopsies to accurately assess the aggressiveness of prostate cancer?
The trial is divided in 2 parts:
* Participants in the first part will receive 2 injections of test drug on 2 different days.
* The first day the participant will receive an injection of the test drug and then be asked to lie down in the PET/CT scanner so that images of the prostate can be taken. Before and after the injection/scanning procedure the participant will have tests done. These tests will include evaluation of health status, measurement of heart function by ECG plus blood and urine samples.
* After 8 days the procedures, including injection of test drug and scanning, will be repeated.
* Participants in the second part of the trial will only have 1 injection of the test drug and subsequent PET/CT scanning. Like in Part 1 of the trial, tests will be done before and after the injection/ scanning procedure.

Start Date01 Jun 2024

Sponsor / Collaborator

Curasight A/S

[+1]

100 Clinical Results associated with 64Cu-DOTA-AE105

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100 Translational Medicine associated with 64Cu-DOTA-AE105

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100 Patents (Medical) associated with 64Cu-DOTA-AE105

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5

Literatures (Medical) associated with 64Cu-DOTA-AE105

28 Feb 2017·Oncotarget

uPAR-targeted optical near-infrared (NIR) fluorescence imaging and PET for image-guided surgery in head and neck cancer: proof-of-concept in orthotopic xenograft model

Article

Author: Juhl, Karina ; Rubek, Niclas ; Kiss, Katalin ; von Buchwald, Christian ; Charabi, Birgitte Wittenborg ; Mortensen, Jann ; Christensen, Anders ; Kjær, Andreas ; Persson, Morten ; Lelkaitis, Giedrius

PURPOSE:

Urokinase-like Plasminogen Activator Receptor (uPAR) is overexpressed in a variety of carcinoma types, and therefore represents an attractive imaging target. The aim of this study was to assess the feasibility of two uPAR-targeted probes for PET and fluorescence tumor imaging in a human xenograft tongue cancer model.

EXPERIMENTAL DESIGN AND RESULTS:

Tumor growth of tongue cancer was monitored by bioluminescence imaging (BLI) and MRI. Either ICG-Glu-Glu-AE105 (fluorescent agent) or 64Cu-DOTA-AE105 (PET agent) was injected systemically, and fluorescence imaging or PET/CT imaging was performed. Tissue was collected for micro-fluorescence imaging and histology. A clear fluorescent signal was detected in the primary tumor with a mean in vivo tumor-to-background ratio of 2.5. Real-time fluorescence-guided tumor resection was possible, and sub-millimeter tumor deposits could be localized. Histological analysis showed co-localization of the fluorescent signal, uPAR expression and tumor deposits. In addition, the feasibility of uPAR-guided robotic cancer surgery was demonstrated. Also, uPAR-PET imaging showed a clear and localized signal in the tongue tumors.

CONCLUSIONS:

This study demonstrated the feasibility of combining two uPAR-targeted probes in a preclinical head and neck cancer model. The PET modality provided preoperative non-invasive tumor imaging and the optical modality allowed for real-time fluorescence-guided tumor detection and resection. Clinical translation of this platform seems promising.

01 Dec 2016·Clinical and translational imagingQ4 · MEDICINE

PET imaging of urokinase-type plasminogen activator receptor (uPAR) in prostate cancer: current status and future perspectives

Q4 · MEDICINE

Review

Author: Skovgaard, Dorthe ; Kjaer, Andreas ; Persson, Morten

Overexpression of urokinase-type plasminogen activator receptors (uPAR) represents an important biomarker for aggressiveness in most common malignant diseases, including prostate cancer (PC). Accordingly, uPAR expression either assessed directly in malignant PC tissue or assessed directly in plasma (intact/cleaved forms)-provides independent additional clinical information to that contributed by PSA, Gleason score, and other relevant pathological and clinical parameters. In this respect, non-invasive molecular imaging by positron emission tomography (PET) offers a very attractive technology platform, which can provide the required quantitative information on the uPAR expression profile, without the need for invasive procedures and the risk of missing the target due to tumor heterogeneity. These observations support non-invasive PET imaging of uPAR in PC as a clinically relevant diagnostic and prognostic imaging method. In this review, we will focus on the recent development of uPAR PET and the relevance within prostate cancer imaging. Novel antibody and small-molecule radiotracers-targeting uPAR, including a series of uPAR-targeting PET ligands, based on the high affinity peptide ligand AE105, have been synthesized and tested in vitro and in vivo in preclinical murine xenograft models and, recently, in a first-ever clinical uPAR PET study in cancer patients, including patients with PC. In this phase I study, a high and specific uptake of the tracer ⁶⁴Cu-DOTA-AE105 was found in both primary tumors and lymph node metastases. The results are encouraging and support large-scale clinical trials to determine the utility of uPAR PET in the management of patients with PC with the goal of improving outcome.

01 Jan 2015·TheranosticsQ1 · MEDICINE

First-in-human uPAR PET: Imaging of Cancer Aggressiveness

Q1 · MEDICINE

ArticleOA

Author: Kjaer, Andreas ; Loft, Annika ; Skovgaard, Dorthe ; Holm, Søren ; Nielsen, Carsten H ; Klausen, Thomas Levin ; Ploug, Michael ; Persson, Morten ; Thurison, Tine ; Berthelsen, Anne Kiil ; Madsen, Jacob ; Brandt-Larsen, Malene ; Højgaard, Liselotte ; Christensen, Camilla ; Kroman, Niels ; Pappot, Helle ; Brasso, Klaus

A first-in-human clinical trial with Positron Emission Tomography (PET) imaging of the urokinase-type plasminogen activator receptor (uPAR) in patients with breast, prostate and bladder cancer, is described. uPAR is expressed in many types of human cancers and the expression is predictive of invasion, metastasis and indicates poor prognosis. uPAR PET imaging therefore holds promise to be a new and innovative method for improved cancer diagnosis, staging and individual risk stratification. The uPAR specific peptide AE105 was conjugated to the macrocyclic chelator DOTA and labeled with (64)Cu for targeted molecular imaging with PET. The safety, pharmacokinetic, biodistribution profile and radiation dosimetry after a single intravenous dose of (64)Cu-DOTA-AE105 were assessed by serial PET and computed tomography (CT) in 4 prostate, 3 breast and 3 bladder cancer patients. Safety assessment with laboratory blood screening tests was performed before and after PET ligand injection. In a subgroup of the patients, the in vivo stability of our targeted PET ligand was determined in collected blood and urine. No adverse or clinically detectable side effects in any of the 10 patients were found. The ligand exhibited good in vivo stability and fast clearance from plasma and tissue compartments by renal excretion. In addition, high uptake in both primary tumor lesions and lymph node metastases was seen and paralleled high uPAR expression in excised tumor tissue. Overall, this first-in-human study therefore provides promising evidence for safe use of (64)Cu-DOTA-AE105 for uPAR PET imaging in cancer patients.

2

News (Medical) associated with 64Cu-DOTA-AE105

22 Jan 2024

·www.prnewswire.com

Curasight A/S Achieves First Milestone under collaboration with Curium Inc.

USD 500.000 payment is the first milestone under the global license and collaboration agreement for the development and commercialization of uTRACE® for use in prostate cancer between Curasight A/S and Curium Inc. Milestone relates to the validation of GMP manufacturing of finished product and illustrates progress in the development plan for uTRACE® PET imaging technology Under the agreement signed in 2023 Curasight is eligible to receive up to mUSD 70 in development milestones plus additional commercial milestones and double-digit royalties on sales upon commercialization COPENHAGEN, Jan. 22, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or "the Company") – (TICKER: CURAS) today announced the achievement of the first milestone under the agreement with Curium inc., to develop Curasight's uTRACE® PET imaging technology for the improved diagnosis of prostate cancer. The milestone relates to the validation of GMP manufacturing of finished product. The USD 500.000 milestone is the first in the agreement signed with Curium Inc. in May 2023. Under the terms of the deal Curasight will develop its proprietary uTRACE® technology for use in prostate cancer until regulatory approval is granted in the EU and USA with Curium responsible for the commercial manufacture of uTRACE® and world-wide commercialization. Curasight is eligible to receive up to mUSD 70 in development and commercial milestones as well as double-digit percentage royalties on sales in major markets upon eventual commercialization. "Reaching this milestone illustrates the strong progress being made under our agreement with Curium – a global leader in nuclear medicine and an expert in developing, manufacturing and commercializing world-class radiopharmaceutical products," said Curasight's CEO Ulrich Krasilnikoff. "Today's news is also a testament to the hard work and commitment of our team in pursuing our mission to use Curasight's uPAR theranostic platform to improve cancer treatment with more accurate diagnosis using uTRACE® and a more efficient, gentle, and targeted treatment with uTREAT®" About the Phase 2 trial with uTRACE® in prostate cancer The primary objective of the phase 2 trial is to investigate Curasight's first-in-class PET tracer, 64Cu-DOTA-AE105 as a non-invasive grading tool of prostate cancer patients that are followed in active surveillance. Patients in active surveillance are continuously monitored for changes in the aggressiveness of their prostate cancer and can be followed for years without identifying the need for treatment. The trial design is informed from research and earlier studies with uTRACE® as well as protocol discussions with the US Food and Drug Administration (FDA). The phase 2 trial is part of the development framework agreed under the deal with Curium. About the uPAR diagnostic platform The uTRACE® platform is part of Curasights uPAR theranostic solution, made up of its uTRACE® diagnostic technology and its uTREAT® targeted treatment technology. In prostate cancer, uTRACE® is presently developed for diagnostic purposes only. Curasight's ambition is to develop both uTREAT® and uTRACE® to improve diagnosis and treatment solutions of certain cancers. About Curium Curium is a global leader in radiopharmaceuticals. Curium develops, manufactures, and distributes world-class radiopharmaceutical products to help patients around the globe. Their proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET, and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. . For more information regarding Curasight, please contact: Ulrich Krasilnikoff, CEO Phone: +45 22 83 01 60 E-mail: [email protected] The following files are available for download:

License out/inPhase 2

22 Jan 2024

·www.prnewswire.com

Curasight A/S Achieves First Milestone under collaboration with Curium Inc.

USD 500.000 payment is the first milestone under the global license and collaboration agreement for the development and commercialization of uTRACE® for use in prostate cancer between Curasight A/S and Curium Inc. Milestone relates to the validation of GMP manufacturing of finished product and illustrates progress in the development plan for uTRACE® PET imaging technology Under the agreement signed in 2023 Curasight is eligible to receive up to mUSD 70 in development milestones plus additional commercial milestones and double-digit royalties on sales upon commercialization COPENHAGEN, Jan. 22, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or "the Company") – (TICKER: CURAS) today announced the achievement of the first milestone under the agreement with Curium inc., to develop Curasight's uTRACE® PET imaging technology for the improved diagnosis of prostate cancer. The milestone relates to the validation of GMP manufacturing of finished product. The USD 500.000 milestone is the first in the agreement signed with Curium Inc. in May 2023. Under the terms of the deal Curasight will develop its proprietary uTRACE® technology for use in prostate cancer until regulatory approval is granted in the EU and USA with Curium responsible for the commercial manufacture of uTRACE® and world-wide commercialization. Curasight is eligible to receive up to mUSD 70 in development and commercial milestones as well as double-digit percentage royalties on sales in major markets upon eventual commercialization. "Reaching this milestone illustrates the strong progress being made under our agreement with Curium – a global leader in nuclear medicine and an expert in developing, manufacturing and commercializing world-class radiopharmaceutical products," said Curasight's CEO Ulrich Krasilnikoff. "Today's news is also a testament to the hard work and commitment of our team in pursuing our mission to use Curasight's uPAR theranostic platform to improve cancer treatment with more accurate diagnosis using uTRACE® and a more efficient, gentle, and targeted treatment with uTREAT®" About the Phase 2 trial with uTRACE® in prostate cancer The primary objective of the phase 2 trial is to investigate Curasight's first-in-class PET tracer, 64Cu-DOTA-AE105 as a non-invasive grading tool of prostate cancer patients that are followed in active surveillance. Patients in active surveillance are continuously monitored for changes in the aggressiveness of their prostate cancer and can be followed for years without identifying the need for treatment. The trial design is informed from research and earlier studies with uTRACE® as well as protocol discussions with the US Food and Drug Administration (FDA). The phase 2 trial is part of the development framework agreed under the deal with Curium. About the uPAR diagnostic platform The uTRACE® platform is part of Curasights uPAR theranostic solution, made up of its uTRACE® diagnostic technology and its uTREAT® targeted treatment technology. In prostate cancer, uTRACE® is presently developed for diagnostic purposes only. Curasight's ambition is to develop both uTREAT® and uTRACE® to improve diagnosis and treatment solutions of certain cancers. About Curium Curium is a global leader in radiopharmaceuticals. Curium develops, manufactures, and distributes world-class radiopharmaceutical products to help patients around the globe. Their proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET, and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. . For more information regarding Curasight, please contact: Ulrich Krasilnikoff, CEO Phone: +45 22 83 01 60 E-mail: [email protected] The following files are available for download: SOURCE Curasight

License out/inPhase 2

100 Deals associated with 64Cu-DOTA-AE105

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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 2	Denmark	Curasight A/S	01 Jun 2024
Adenocarcinoma of prostate	Phase 2	Sweden	Curasight A/S	01 Jun 2024
Localized Prostate Carcinoma	Phase 2	Denmark	Curasight A/S	01 Jun 2024
Localized Prostate Carcinoma	Phase 2	Sweden	Curasight A/S	01 Jun 2024
Neoplasms	Phase 1	Denmark	Rigshospitalet	13 Sep 2015