Back in 2021 Curasight presented promising phase II results from an investigator initiated phase II study with uTRACE in prostate cancer. About two years later, the company now secures a first licence deal for its theranostic platform. BioStock contacted CEO Ulrich Krasilnikoff to talk about what this means for the company and its development.
Copenhagen-based biotech Curasight develops a technology that revolves around the uPAR receptor, a known biomarker for cancer aggressiveness. The company´s PET-tracer ligand uTRACE is a new non-invasive diagnostic tool. It is designed to localise and assess cancer aggressiveness in various forms of cancer. The company has presented positive phase II results in prostate cancer, head- and neck cancer, and neuroendocrine tumours. The focus has increasingly been on securing a partnership deal to further advance the development of the candidate.
Partnership deal with Curium
Recently, Curasight announced a deal with the global leader in radiopharmaceuticals Curium. The deal is regarding uTRACE for the diagnosis in prostate cancer patients. In prostate cancer, the aim is to position uTRACE as an alternative or a supplement to traditional biopsies in the active surveillance of the patients.
In the deal, Curasight is eligible for up to 70 MUSD in milestone payments. It will also receive double-digit royalty payments on upcoming sales. Curasight will be responsible for the further development of the candidate. Curium will be in charge of manufacturing and commercialisation. Curasight will keep all rights to develop and commercialise uTRACE in all other indications outside prostate cancer.
Feedback from the FDA
When announcing the Curium-deal, Curasight also communicated that it had received feedback from the FDA in a pre-IND meeting about the development plan for the 64Cu-labeled version of the candidate.
Instead of Gallium-68, this version uses Copper-64 as the imaging radionuclide. Adding this imaging compound to the portfolio is an important commercial step in building a strong position in the field. One advantage of the Copper-64 version of uTRACE is that it has a long shelf-life. This allows for central distribution from few production sites.
Comments from the CEO
BioStock contacted Curasight CEO Ulrich Krasilnikoff to learn more about what this all means for the development.
First and foremost, what does it mean for Curasight to have secured this deal?
– Curasight is committed to improving cancer treatments with more accurate diagnosis using intelligent cancer imaging and more gentle, targeted treatment using radionuclide therapy. This deal provides validation of Curasight’s uTRACE diagnostic platform within prostate cancer.
– Furthermore, the deal provides Curasight with non-diluting funding up to 70 MUSD in development and commercial milestones as well as double-digit royalties for sales upon commercialisation. The deal is an example of how Curasight intends to leverage industry partnerships in order to accelerate product development and gain speed to the market.
What can you tell us about your new partner, Curium?
– Curium is the world’s largest nuclear medicine company and an expert in developing, manufacturing and commercialising world-class radiopharmaceutical products across the world.
– Furthermore, Curium has proven skills in commercialising products. One example is Detectnet, a similar product for use with PET for localisation of somatostatin receptor positive neuroendocrine tumors. This partnership provides valuable competences and know-how in regulatory and commercialisation to complement Curasight’s R&D skills.
Looking at the next step for uTRACE in prostate cancer, will you be financing the upcoming clinical development yourselves or is that part of the milestone payments?
– Curasight is responsible for clinical development which will mainly be covered by the milestones payments. Curium will provide regulatory and commercialisation expertise as we work to secure marketing approval for uTRACE in prostate cancer.
Are there any ongoing discussions within the other indications?
– Yes, there are ongoing discussions within the other indications, but we cannot comment more specific on ongoing business development activities. In that respect, is it important to emphasise that Curasight’s strategy is to leverage strategic partnerships to accelerate our ambition to deliver improved cancer treatment with more accurate diagnosis and more gentle, targeted treatment in all the other cancer types in our pipeline.
What would it mean for prostate cancer patients to have uTRACE reach the market?
– For prostate cancer patients with localised disease that are followed in active surveillance, the uncomfortable and side-effect prone (bleeding and infection) invasive biopsies would largely be replaced by a gentler PET scan of less than 20 min.
– In addition to this, we expect that due to the easier and more reliable way to follow these patients using uTRACE instead of biopsies, a reduction in the number of prostatectomies performed may be seen. Indeed, data from the literature indicate that up to 80 per cent of the surgical removals of the prostate gland, the prostatectomies, are performed unnecessarily, i.e., in localised disease that would not have spread. This overtreatment is not trivial, as up to 70 per cent of patients experience some degree of impotence and/or urinary incontinence following prostatectomy.
– Taken together, we believe that uTRACE may improve the quality of life of many prostate cancer patients.
Lastly, you have also received feedback from the FDA on the 64Cu-labeled version of uTRACE. What was the feedback and what is the next step?
– Overall, the FDA acknowledged the concept of uTRACE as a first-in-class imaging technology for active surveillance in prostate cancer patients. They gave some relevant suggestions that will be taken into consideration in our development plan. The next step is to finalise and file the clinical trial application.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.