Copenhagen-based Curasight is based on the uPAR protein in the development of drug candidates uTRACE- and uTREAT. The uPAR receptor is found in a wide range of human cancer malignancies and high expression has been linked to a higher likelihood of metastasis – i.e. more severe disease and an increased risk of adverse outcome.
Curasight's diagnostic PET tracer uTRACE has been successfully validated in over 400 patients in repeated clinical studies, testing the candidate in a range of cancer types. The second part of the concept, uTREAT, is based on the same platform, but has been equipped with a beta-emitting radionuclide, which provides precise short-range radiation therapy. Last year, Curasight presented positive preclinical results with uTREAT in both glioblastoma and non-small cell lung cancer, showing that the drug candidate inhibits tumor growth.
The company recently announced an updated strategy, in which it intends to develop uTRACE and uTREAT in parallel, with the goal of offering better diagnosis and more gentle and targeted treatment of various cancers.
Planning study in multiple indications
The company plans to conduct a Phase I/IIa study with patients from five different cancer indications: glioblastoma, neuroendocrine tumors, head and neck cancer, non-small cell lung cancer and pancreatic cancer. The first patients are expected to be dosed in early 2025 and Curasight expects to present a first readout of efficacy data later that year.
In conjunction with the presentation of the study plans, the company also announces its intention to raise approximately DKK 51 million in a rights issue to finance the study. In addition to financing preparations, planning and recruitment of the first patients for the phase I/IIa study, the proceeds from the issue are also intended for further development of the next generation of novel peptide-based radioligands.
Vd Ulrich Krasilnikoff, co-founder Andreas Kjaer and CDOs Hanne Damgaard Jensen has committed to subscribe for shares for a total of approximately DKK 1,3 million in the rights issue, which corresponds to 2,5 percent of the total issue amount.
First deal secured for prostate cancer
Curasight's business strategy is to enter into partnerships with major pharmaceutical companies to carry out the later stages of clinical development and take the projects to market approval. Last year, the company signed an important licensing agreement with Curium regarding the use of uTRACE in prostate cancer. The deal is seen as an important validation of the technology and Curasight recently announced that it had received an initial milestone payment of USD 500 from the collaboration.
In total, Curasight is eligible to receive milestone payments of up to USD 70 million, as well as double-digit percentage royalties on future sales. Preparations for a Phase II study are currently underway and the study is expected to provide the next milestone payment in Q2 2024. The company aims to be able to announce interim results from the study in Q3 2024.
CEO comment
BioStock contacted Curasight CEO Ulrich Krasilnikoff to learn more about the next steps for the company.
You are planning for a phase I/IIa basketball trial, where you test several cancer indications at the same time. Why have you decided on this route?
- We believe the theranostic approach using radiopharmaceuticals to both diagnose and treat certain types of cancer has the potential to provide important new solutions to clinicians and patients. By launching this basket trial, we can accelerate the development of both uTRACE and uTREAT in parallel and potentially have therapeutic efficacy data already during 2025.
– The trial of five cancer types in parallel takes advantage of our theranostic platform working across tumor types as uPAR is expressed in the majority of all solid cancers. We have already achieved important results in most of the indications with our diagnostics platform uTRACE as well as positive preclinical results in brain and lung cancer using our therapeutic solution uTREAT. This also increases the likelihood of entering into partnering with pharmaceutical companies.
Can you elaborate on how such a trial is structured?
– The coming phase I/IIa basket trial is planned to include five select cancer indications: Brain cancer (Glioblastoma), neuroendocrine tumors (NET), head-and-neck cancer (HNSCC), non-small cell lung cancer (NSCLC), and pancreatic cancer. The trial will apply Curasight's uPAR theranostic platform approach combining diagnosis (uTRACE) and therapy (uTREAT). The first patients expected to be dosed in the beginning of 2025 with expected first efficacy data in 2025. The trial is expected to consist of five cohorts of approximately 20 participants in each cohort. This is considered sufficient to proceed to the next phase, which will be a phase IIb/III trial.
– The basket trial will also generate important efficacy data in five different indications, underpinning our theranostic approach of using the results of the uTRACE scan to help categorize and segment the relevant treatment option for patients. Likewise, the data will be important in our business development discussions with big pharma as we seek partnerships to support future development and potential commercialization.
What is the next step after that trial, given good results?
– After the basket trial a next step in clinical development would be a phase IIb/III trial. We are committed to developing partnerships to support later stage development and eventual commercialization, so we will continue our business development activities in the coming time seeking out potential partners.
Announcing the rights issue you also mentioned the development of new next generation peptide-based radioligands. Can you shed some more light on that?
- In connection with the development of new radioligands and peptides, science is constantly looking for new isotopes and compositions that can provide the most effective treatment against the cancer cells, while being as gentle and precise as possible for the healthy cells and tissues. In order to be at the cutting edge of science, we are focused on carrying out further research and development for the best way to utilize both alpha and beta emitters depending on which type of cancer we are trying to treat.
With subscription commitments of 2.5 per cent of the rights issue, how confident are you to reach full subscription?
- We believe we have a strong foundation to be able to create value with our accelerated development strategy. As we announced at the time of launching the rights issue, management are very committed to building the business and both myself, our founder and Chief Scientific Officer Andreas Kjær and our Chief Development Officer Hanne Damgaard Jensen are participating in the financing.
What are your best arguments for this being the right time to invest in Curasight?
- The company is in a very exciting place right now in terms of our technology and in the clinical results we have achieved so far. We have a busy year ahead with multiple milestones giving us the opportunity to build further value in the company, eg becoming clinical stage also in therapy.
– Radionuclide treatment within cancer is being recognized as an increasingly important area which could improve cancer diagnosis and treatment and we are well-positioned to deliver new options in this field with additional financing from the rights issue we can accelerate our clinical development efforts for both uTRACE and uTREAT in parallel, and ensure we have a strong financial foundation that will assist us in our business development discussions with big pharma.