The prostate cancer partnership with Curium marks the most pivotal moment for the radiopharmaceutical focused biotech company Curasight to date. Now, the company has announced a first milestone payment under the deal, for the validation of GMP manufacturing of finished product. BioStock reached out to CEO Ulrich Krasilnikoff to learn more.
Curasight’s licensing deal with Curium covers uTRACE, which is one half of Curasight’s radiopharmaceutical theranostics platform, which uses proprietary PET imaging technology to improve diagnosis and treatment of certain cancers. The technology focuses on the uPAR receptor, a known biomarker of cancer aggressiveness, and has shown promise in initial phase II trials in several cancer indications, including prostate cancer.
uTRACE represent a pivotal innovation in prostate cancer diagnostics. It allows for the non-invasive grading of cancer aggressiveness in patients under active surveillance — a program that, in the case of prostate cancer, could span years without the immediate need for treatment.
Licensing deal with Curium
Following initial results with the candidate, Curasight entered a global licensing deal with leading radiopharmaceutical company Curium in May last year – marking the most important milestone for the Danish company to date. Under the deal, Curasight will develop uTRACE up to regulatory approval in the EU and the USA with Curium responsible for its commercial-scale manufacturing and subsequent worldwide commercialisation.
The deal with Curium is a cornerstone of Curasight’s strategy, providing financial support through milestone payments of up to a total of USD 70 million, plus future royalties. The company recently announced a first milestone payment of USD 500,000, relating to the validation of GMP manufacturing of finished product.
Preparing for phase II in prostate cancer
With the previous phase II results stemming from an investigator-initiated, academic trial demonstrating proof-of-principle, the next step is to get solid phase II results that live up to industry standards. This will enable further advancements with the candidate. Currently, preparations are underway for the upcoming trial, with Curasight recently having submitted a clinical trial application and selecting German ABX-CRO for the execution.
The trial will explore the Copper-64-labeled version of uTRACE and will include a total of 168 patients in Sweden, Denmark, Germany and the US. It is scheduled to commence in Q2 of 2024.
Comments from the CEO
BioStock has contacted Curasight CEO Ulrich Krasilnikoff to learn more about the latest milestone and what it means for the company.
Firstly, you just received your first milestone payment from your collaboration with Curium. What does it mean for the project?
– Achieving 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 with a proven ability to commercialise world-class radiopharmaceutical products.
– Furthermore, this first milestone underscores our team’s ability, hard work, and commitment to bringing uTRACE to a GMP manufactured finished product. In this connection, it is important to emphasise that much of the work carried out here, including the processes and logistical setup, can also be used in relation to other cancer indications, which emphasisws that uTRACE is a diagnostic platform.
What will trigger the next milestone payments from the deal?
– We expect to achieve the next milestone in the first half of 2024, which relates to enrolling the first patient for the phase II clinical trial.
What is your view on the current financial status of the company?
– The company has a clear strategy for 2024 to strengthen its financial position through strategic partnerships, as well as a desire to strengthen the investor base with long-term institutional investors who can help bring the company to the next level.
– At the same time, the company has a desire to accelerate the development of our therapeutic platform uTREAT, as there is great interest among big pharma in the technology that uTREAT represents and how it can replace external radiation therapy with a much more gentle and efficient treatment of multiple cancer types via targeted radionuclide treatment.
– This requires additional funding, which is sought to be covered via partnerships or via strengthening the investor base.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.