Curasight to accelerate therapeutic strategy by DKK 51.2 million capital raise
Last year, a lot of focus for Curasight revolved around prostate cancer and the licensing deal with Curium. Now, the company has announced the next step for the theranostic approach and its wish to accelerate clinical development of both uTREAT and uTRACE in parallel. Curasight aims at starting a phase I/IIa basket trial in several indications and in order to finance this updated develoment strategy, the company aims at raising DKK 51.2 million in a rights issue. BioStock contacted CEO Ulrich Krasilnikoff to learn more.
Copenhagen-based biotech Curasight leverages the uPAR-protein in its fight against cancer through its uTRACE and uTREAT technologies. The uPAR receptor is present in a wide array of human malignancies, and its expression levels have been linked to the likelihood of metastasis—meaning the severity of the cancer and the potential for unfavorable outcomes.
uTRACE, Curasight’s diagnostic PET ligand, has undergone successful validation in over 400 patients across numerous clinical studies, which has spanned various types of cancer. Meanwhile, based on the same targeting platform, uTREAT is equipped with a beta-emitting radionuclide, enabling 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 effectively inhibits tumour growth.
The recently announced updated strategy aims at ensuring parallel development of both uTRACE and uTREAT to deliver on the company’s mission of better diagnosis and more gentle and targeted treatment of different cancers.
Plans for a basket trial in several indications
The company is set to move into a phase I/IIa basket trial in five different cancer indications simultaneously: glioblastoma, neuroendocrine tumors, head-and-neck cancer, non-small cell lung cancer, and pancreatic cancer. The first patients are expected to be dosed in the beginning of 2025 and Curasight expects to present a first set of efficacy data later that year.
Announcing this step, the company also unveiled its intention to raise approximately DKK 51 million in a rights issue to fund the study. On top of financing the preparation, planning and enrolment of the first patients for the phase I/IIa-trial, the proceeds are also intended for the further development of new next generation peptide-based radioligands.
CEO Ulrich Krasilnikoff, co-founder Andreas Kjær and CDO Hanne Damgaard Jensen have committed to subscribe for a total of approximately DKK 1.3 million in the rights issue, which corresponds to 2.5 per cent of the full issue.
First deal secured for prostate cancer
Curasight’s strategy is to develop partnerships with leading pharma players in order to support later stages of clinical development and approval. Last year the company signed an important licensing deal with Curium, regarding the use of uTRACE in the diagnosis of prostate cancer patients. The deal provided important validation of the company’s technology and approach and Curasight recently showed the momentum being made in the collaboration when it announced it had received a first USD 500,000 milestone payment.
Curasight is eligible to receive up to USD 70 million in development and commercial milestones as well as double-digit percentage royalties on sales. Preparations for a phase II study are currently underway, and the study is expected to yield the next milestone payment in Q2 2024 and interim results in Q3 of 2024.
Comments from the CEO
BioStock reached out to Curasight CEO Ulrich Krasilnikoff to learn more about this next step for the company.
You are planning for a phase I/IIa basket 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 tumour 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 pharma 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 consists 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 categorise 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 commercialisation.
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 commercialisation, 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 utilise 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, e.g. becoming clinical stage also in therapy.
– Radionuclide treatment within cancer is being recognised 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.
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.
