Following the Curium deal this spring, Curasight has now submitted a clinical trial application and selected a CRO to carry out a phase II trial with uTRACE. The trial intends to evaluate the uTRACE for the diagnosis of prostate cancer patients. BioStock contacted Curasight CEO Ulrich Krasilnikoff to learn more.
Based on a focus on the uPAR receptor, a well-established marker for cancer aggressiveness, Curasight’s uTRACE is leveraging non-invasive assessment of the severity of cancer across various cancer types. Following up on the promising phase II results obtained in 2021, Curasight’s uTRACE has shown potential in prostate cancer, head and neck cancer, and neuroendocrine tumours.
Licencing deal with Curium
This spring the company signed a licensing agreement with Curium, a leading name in the field of radiopharmaceuticals, for the development of uTRACE as a prostate cancer diagnostics tool. Curasight’s vision is to establish uTRACE as either an alternative or a complementary solution to conventional biopsy procedures in prostate cancer patient monitoring.
Financially, the agreement entitles Curasight to receive up to 70 MUSD in milestone payments, along with double-digit royalties on future sales, while maintaining responsibility for the ongoing development of uTRACE. Meanwhile, Curium will handle the manufacturing and commercialisation aspects of the product. Curasight retains the rights to further develop and commercialise uTRACE in imaging indications outside prostate cancer and therapy in any indication using the company’s second product, uTREAT.
Assigns CRO for phase II trial
Taking the next step in the partnership, Curasight announced that it had submitted a clinical trial application to the European Medicines Agency (EMA) for a phase II trial with uTRACE in prostate cancer. The company has also assigned ABX-CRO for the execution of the study.
ABX-CRO is a German-based CRO with extensive experience in conducting international diagnostic and therapeutic trials with radiopharmaceutical agents. The study is a significant component of the agreement with Curium and the target is to dose the first patient in Q2 of 2024.
Evaluates copper version of uTRACE
The phase II trial’s primary goal is to evaluate uTRACE, specifically the Copper-64-labeled version, as a non-invasive grading tool for prostate cancer patients under active surveillance. In connection with the Curium deal, Curasight disclosed that they had received constructive feedback from the FDA in a pre-IND meeting regarding this version of uTRACE, which is seen as a substantial commercial step for the company.
The copper labelled version of uTRACE offers logistical advantages due to its long shelf-life, allowing for centralised distribution from a limited number of production sites, thereby potentially streamlining the supply chain and improving market reach.
The trial design, informed by previous research and FDA discussions, will be conducted in two parts across university hospitals in Denmark, Sweden, Germany, and the US.
Comments from the CEO
BioStock contacted Curasight CEO Ulrich Krasilnikoff to learn more about the trial.
First and foremost, you already have phase II results with uTRACE in prostate cancer. Why is yet another phase II trial required?
– The previous phase II trial was an investigator-initiated, academic trial and was characterised by being of more exploratory character, demonstrating proof-of-principle. The phase II trial to be initiated by Curasight is designed and powered to deliver solid results, that live up to industry standards and is informed by the previous phase II trial as well as guidance from FDA.
– Additionally, prior research on uTRACE was based on the 68Ga isotope (gallium-68). Going forward, we use the 64Cu isotope. While the two versions of uTRACE bind and work essentially in the same manner, from a regulatory perspective they are not considered exactly the same. In addition, the absolute uptake values differ between the two isotopes and the cut off has to be established for each of the compounds.
– In addition to the logistical advantages of working with the 64Cu isotope, we also benefit from Curium’s expertise in this field, being the world’s largest radiopharmaceutical company with a global production and distribution setup based on the isotope 64Cu.
– The primary objective of this phase II trial is to investigate Curasight’s first-in-class PET tracer, uTRACE 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 earlier academic research with uTRACE as well as protocol discussions with the FDA.
How many patients will be included in the trial?
– The trial will be conducted in two parts, with the first part of the trial conducted at three different university hospitals in Denmark and Sweden. For part two, the trial will be expanded to also include university hospitals in Germany as well as transatlantic hospitals in the US. In total, 168 patients will be included in the trial, divided by 27 in a part one of the trial and 141 in part two.
You aim to start the trial in Q2 of 2024. When do you hope to present the first results?
– Starting the trial in Q2 2024, the last patient is expected to be enrolled in Q1 2025. We expect to report results from the study after part I, which is planned to be Q3 2024.
Looking at the financing of the trial, who picks up the bill?
– Curasight is financing the trial, but will along the way receive milestone payments from Curium in connection with the clinical development as the milestones are met.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.