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Curasight

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

January 22, 2024

Regulatory


· 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, January 22, 2024 - 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.  www.curiumpharma.com.

For more information regarding Curasight, please contact:

Ulrich Krasilnikoff, CEO

Phone: +45 22 83 01 60

E-mail: uk@curasight.com

www.curasight.com

Curasight is a clinical development company based in Copenhagen, Denmark. The Company is a pioneer in the field of exploiting a novel Positron Emissions Tomography (PET) imaging (uTRACE®) and Radioligand Therapy (uTREAT®) Theranostic Platform targeting the urokinase-type plasminogen activator receptor (“uPAR”). The technology is expected to improve diagnosis and provide more gentle and efficient treatment of multiple cancer types.