Spago Nanomedical has achieved a significant milestone in its cancer therapy development journey. The company’s drug candidate, 177Lu-SN201, has received approval to initiate the clinical phase I/IIa study, Tumorad-01, in Australia. To fully appreciate this endeavour, BioStock reached out to Spago’s CEO Mats Hansen.
So-called radionuclide therapy (RNT) is quickly becoming a valuable alternative or complement to existing cancer treatments, especially in cases of aggressive cancers. The idea is to use nanoparticles to selectively target tumour tissue and facilitate local radiation without affecting healthy tissue. This type of therapy is the basis for Spago Nanomedical’s Tumorad project, where the clinically validated radioisotope Lutetium-177 is combined with Spago’s functional nanoparticles, forming Spago’s candidate 177Lu-SN201
In January, the scientific journal ACS Omega published an article presenting the structure, stability and mechanism of action of 177Lu-SN201. In short, the preclinical data show that the drug candidate accumulates in cancerous tumours and inhibits their growth, which leads to prolonged survival in a preclinical model for colon cancer. Learn more.
Phase I/IIa approval
Soon after the publication, Spago submitted an application to the Australian regulators for starting a phase I/IIa study with 177Lu-SN201 in advanced cancer. The aim of the dose escalation and dose expansion study is to validate the safety and tolerability of the candidate, as well as its initial efficacy and of this technology. This week, Spago received the approval to commence the Tumorad-01 study from the ethics review committee at St. Vincent’s Hospital in Melbourne. According to the company, site initiations are already underway and patient recruitment is expected to follow immediately thereafter.
»The start of the study marks the transition into clinical development of our radionuclide therapy programme Tumorad and is a very important milestone for Spago Nanomedical as it provides a firm foothold in cancer pharmaceuticals on top of our previous track record in imaging diagnostics« — Mats Hansen, CEO Spago Nanomedical
The phase I segment is expected to involve up to 30 cancer patients, aiming to establish a viable therapeutic dose based on safety and biodistribution. Subsequently, this dose will undergo rigorous testing in selected patient cohorts during the phase IIa portion. 177Lu-SN201‘s favourable radiation distribution in tumours compared to other organs offers potential as a novel cancer treatment. The first patient inclusion is anticipated in the fourth quarter of 2023.
Australia comes with many benefits
This regulatory milestone paves the way for the study’s commencement. Australia, with its regulatory and financial advantages, provides an ideal setting for this innovative research. These advantages encompass the potential for substantial reimbursement of research and development costs, along with the familiarity of authorities and hospitals with radiopharmaceuticals.
A chat with the CEO
Overall, the approval is a huge milestone for the company as it works towards developing new and better treatments for cancer. BioStock got in touch with Spago’s CEO Mats Hansen to learn more about the impact of this milestone.
Mats, how does it feel to receive the approval from the Australian authorities to begin the Tumorad-01 trial?
– We are of course happy and very excited to start this first clinical study with 177Lu-SN201. We have a strong belief in the Tumorad programme and its potential to bring a promising new radiopharmaceutical for a range of aggressive and metastatic cancers. The persisting and significant medical need for more effective treatments and a growing interest in new radionuclide therapies certainly keeps us strongly motivated.
How significant is this milestone?
– The start of the study marks the transition into clinical development of our radionuclide therapy programme Tumorad and is a very important milestone for Spago Nanomedical as it provides a firm foothold in cancer pharmaceuticals on top of our previous track record in imaging diagnostics.
Could you give us a quick rundown of the study design and its main aim?
– The now approved clinical study is a phase I/IIa, dose escalation and dose expansion, first-in-human study in patients with advanced cancer. The phase I part of the study will be conducted in up to 30 cancer patients that will be closely monitored to further our understanding of the biodistribution and initial safety of 177Lu-SN201. It is designed to allow us to safely increase the dose to a point where we believe we have the right dose to use to provide the maximum benefit to a patient balanced against side effects that may be seen. Importantly, a radiopharmaceutical like 177Lu-SN201 carries the inherent benefit of being able to trace or image even at low doses which should allow us to make valuable projections of benefit versus risk early on in the study.
What are some of the additional benefits that come with running the trial in Australia?
– Australia offers an excellent framework for our study by provision of several competent clinical sites, radiopharmaceutical manufacturing providers, and a beneficial governmental incentive system for clinical R&D. The Australian sites are very experienced in running trials of this type with radiopharmaceuticals like 177Lu-SN201. Our chosen sites are located in highly populated areas and are close to the manufacture of 177Lu-SN201. The substantial reimbursement of R&D costs offered by the Australian Government provides an attractive financial benefit that allows us to progress Tumorad and offer 177Lu-SN201 to cancer patients in a cost-effective way.
What is the expected timeline for the Tumorad-01 study, and when might investors expect to see results?
– We anticipate the first patient being dosed in Q4 this year which would allow us to see preliminary biodistribution data in the first half of 2024. That is expected to provide indications of the potential to reach a therapeutic dose and a favourable benefit-risk balance.
Finally, what are any potential risks and/or challenges associated with the Tumorad-01 project?
– While we hope that 177Lu-SN201 will prove to be beneficial for cancer patients in the future it is at this early stage an experimental treatment. The translation from animal models to humans requires that we proceed with care to minimise risks to those volunteering to take part in the study. The data we acquire from the first patients, especially around biodistribution of 177Lu-SN201 will greatly increase our understanding of the drug and where it might be best used in the treatment of cancer patients. We strive to keep an efficient and agile organisation, and we are usually able to act and constructively address any challenges at an early stage.Innehållet i BioStocks nyheter och analyser är oberoende men BioStocks verksamhet är i viss mån finansierad av bolag i branschen. Detta inlägg avser ett bolag som BioStock erhållit finansiering från.