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. Licensing 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 Second Quarter 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.