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

Mechanism

uPAR inhibitors(Urokinase plasminogen activator surface receptor inhibitors), PET imaging(Positron-emission tomography enhancers)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Prostatic CancerNeoplasms

Inactive Indication-

Originator Organization

Active Organization

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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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

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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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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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