Curasight is developing a theranostic platform that combines precise cancer diagnostics (uTRACE) with targeted radiotherapy (uTREAT). The company’s imaging agent detects uPAR, a biomarker overexpressed in aggressive tumours, while its therapeutic counterpart uses the same target to deliver radionuclides directly to cancer cells. Together, the two platforms aim to make cancer diagnosis and treatment more accurate and less invasive.
The phase II study in prostate cancer is part of Curasight’s strategic collaboration with Curium Inc., a global leader in nuclear medicine (signed in 2023). Under this partnership, Curasight is eligible for up to USD 70 million in milestone payments as well as double-digit royalties upon commercialization. The study evaluates uTRACE as a non-invasive PET imaging tool to better distinguish indolent from aggressive prostate tumours, potentially allowing clinicians to avoid unnecessary treatment in patients under active surveillance.
Building long-term value through stronger IP
In parallel with clinical progress, Curasight has recently strengthened the patent protection for uTRACE in the US, extending exclusivity until 2035. The extended protection broadens the commercial potential of the company’s diagnostic platform and supports its dual-track strategy of developing both uTRACE and uTREAT in parallel. In a previous BioStock interview, CEO Ulrich Krasilnikoff said that:
- Strong patent protection is high on the agenda in all discussions with potential partners, as it gives us more time with exclusivity for our innovation so that we can further explore uTRACE's application in other types of cancers.
Combined with the ongoing clinical advancements, the stronger IP position provides Curasight with additional long-term value and partnership potential.
Milestone reached with all sites now active
The activation of all European trial sites marks a significant operational milestone for Curasight. With part 1 confirming the feasibility of the company’s imaging approach, part 2 will focus on further validating uTRACE’s diagnostic potential in a larger patient population. According to Curasight, patient recruitment is proceeding on track, with completion expected in the first half of 2026.
Next step: therapeutic arm moves into the clinic
Meanwhile, Curasight is preparing to take the therapeutic part of its platform, uTREAT, into clinical testing. Following the European Medicines Agency’s recent acceptance of the company’s clinical trial application, a phase I study in glioblastoma is expected to begin before the end of 2025, with initial safety results expected by late 2025 or early 2026.
Comments from the CEO
BioStock reached out to CEO Ulrich Krasilnikoff to discuss the implications of the expanding uTRACE trial, and how Curasight is preparing for its next stage of growth.
With all clinical sites now active in the uTRACE phase II trial, what key outcomes do you expect this next stage to deliver?
- The phase 2 is aimed at testing uTRACE to more accurately show how aggressive a prostate tumor is in patients with prostate cancer. We know uTRACE will make diagnosis less invasive and more precise, helping doctors choose the right treatment for patients without the need for invasive biopsies.
What kind of feedback are you receiving from clinicians and investigators involved in the study?
- We have to wait for the data from this study, but we know there is a need for improved diagnosis in prostate cancer, and as uTRACE has already been tested in multiple clinical studies we believe it could provide an important new option to help doctors make more accurate diagnosis.
How do you see the results of this trial influencing the broader use of PET imaging in prostate cancer management?
– This trial is an important step forward in bringing non-invasive diagnosis, and particularly uTRACE, closer to being a new option for doctors treating cancer patients. The biggest problem today is how to recognize the tumors that do not require radical prostatectomy – as many prostate cancer patients have their prostate gland removed unnecessarily based on a better safe than sorry approach.
- This is because 12-needle biopsies are used, where with this procedure it is easy to overlook an aggressive tumor in the prostate gland. With uTRACE we get a better and more reliable diagnostic tool that can give the patient a clear answer right away whether the tumor is aggressive or not and thus avoid unnecessary prostatectomies that cause impotence and urinary incontinence by 70 per cent of the patients getting prostatectomy.
Looking ahead, what milestones will be most defining for Curasight over the next 12 months?
- We have a busy 12-month plan to initiate our phase 1 study in brain cancer for our treatment arm uTREAT and according to our planning this trial should recruit rapidly so we anticipate data to come before the end of the year. We also expect to have preliminary data from the uTRACE study in prostate cancer in the first half of next year.
The content of BioStock's news and analysis is independent, but BioStock's operations are to some extent financed by companies in the industry. This post refers to a company from which BioStock has received funding.