Curasight targets clinical proof-of-concept for uTREAT
Having secured financing for the ongoing clinical development of uTRACE, Curasight can now enter the next level in developing the therapeutic side of its theranostic approach. This will be done by rapidly achieving proof-of-concept in a single indication with uTREAT. BioStock contacted CEO Ulrich Krasilnikoff in conjunction with the Q2 report to learn more.
Copenhagen-based Curasight specializes in the development of imaging diagnostics and targeted treatment solutions for cancer with the aim of improving survival outcomes for patients with various types of cancer. Its theranostic approach uses a radioactive tracer targeting the uPAR biomarker to visualize cancer activity within tumours, enabling more precise diagnosis, and then enabling more targeted radiotherapy treatment of the cancer by directly attacking cancer cells.
With strong momentum in its ongoing clinical phase II study with radio ligand uTRACE in prostate cancer, Curasight aims to accelerate its treatment platform uTREAT into clinical trials as soon as possible. Following detailed discussions with key opinion leaders and industry players, the company intends to run a small trial in a single indication to achieve a more rapid route to proof-of-concept with uTREAT. The next step will then be to initiate its planned phase I/IIa basket trial in five different cancer indications: glioblastoma, neuroendocrine tumours, head-and-neck cancer, non-small cell lung cancer, and pancreatic cancer.
Initial focus on one indication with uTREAT
During the first half of the year, Curasight has worked hard to identify the most optimal single cancer indication that could be used to run a relatively cost-effective and swift trial, which would provide the first clinical validation of the technology.
Since the uPAR-biomarker is cancer-specific but not limited to a single cancer type, it is applicable across various cancer types. Following this initial proof of concept, the next step will be to conduct the larger, more complex basket to further validate uTREAT’s broad applicability.
Presented funding package
During the first half of 2024, a lot of work has been put into establishing a solid financial foundation. The aim has been to find a funding solution that creates value for shareholders while maintaining progress in the company’s development activities.
In July, Curasight was able to present a financing package consisting of a directed share issue, loan financing, and two tranches of warrants, providing a crucial capital boost. The transaction secures potential new funding of up to DKK 120 million, providing strategic flexibility and extending the company’s cash runway into the second half of 2025.
In Q2, cash flow from operating activities amounted to DKK -13,5 million. Including a first tranche of the loan facilities, the cash flow was DKK -3,5 million, and the company ended the period with a cash position of approximately DKK 8,4 million.
Comments from the CEO
BioStock reached out to Curasight CEO Ulrich Krasilnikoff to learn more.
Firstly Ulrich, how would you characterize the second quarter of 2024 for Curasight?
– During the second quarter of 2024, we have continued to build on our successes from the past year. We have enrolled the first patient in our phase II trial with uTRACE in prostate cancer, illustrating the rapid progress in our partnership with Curium and triggering the second milestone payment under this collaboration.
– We also announced a capital raise aimed at further strengthening the company’s finances. Lastly we have been focused on identifying the single indication that can give us the most rapid pathway to proof of concept with our uTREAT platform. We look forward to being able to announce more on this in the second half of the year.
Looking specifically at uTREAT, you´ve decided to start evaluating the candidate in one specific indication. What feedback have you received from the market regarding the project?
– Through discussions with big pharma and key opinion leaders we understand the importance of demonstrating clinical “proof-of-concept” for uTREAT as soon as possible. Therefore, we are very focused on identifying the most suitable single indication for this rapid route where we could run a relatively cost effective small trial that can be completed in a relatively short time frame to provide this first validation of uTREAT.
– As the uPAR-biomarker is cancer specific but not cancer type specific it works across cancer types. Therefore, our aim is to find a route for rapid proof of concept which we can then follow up with a larger and more complex basket study with five different indications to provide further broader evidence of the application in different cancer types.
Can you tell us something about what you are considering regarding what indication to choose for the fist study?
– Our starting point has always been to identify a cancer indication where there is an unmet need for treatment. At the same time, we seek to ensure it would be an indication of interest to potential partners.
Looking at the rest of the year, what milestones do you hope to achieve?
– Looking ahead to the rest of 2024, we anticipate further progress in our pipeline. This means we expect to have preliminary efficacy data from the ongoing phase II trial in prostate cancer with uTRACE (Curium by partnership) at the end of the year.
– Furthermore, we expect to initiate the work with the individual indication in uTREAT, once this has been selected and announced. At the same time, we expect to further secure our financial base with the execution of the next step in our financing package. This includes the issuance of T02 and T03 warrants to our current shareholders, where T02 can be exercised in the 4th quarter of 2024.
– Finally, we are also focused on continuing discussions with different players within this area in the pharmaceutical industry as Radionuclide Ligand Therapy (RLT) continues to be in focus as an important option within radiotherapy in cancer.
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.
