On January 12, 2023 Spago Nanomedical reported Preclinical data with Spago Nanomedical’s radionuclide therapy concept Tumorad was recently published in the scientific journal ACS Omega (Press release, Spago Nanomedical, JAN 12, 2023, View Source [SID1234626209]). The paper describes the composition, stability and mode of action for the drug candidate 177Lu-SN201 and concludes that the candidate’s properties are suitable for systemic treatment of cancer. BioStock reached out to CEO Mats Hansen to learn more on what this means for the project.
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In recent years, research in radiation therapy for cancer has advanced and has led to several approved drugs, such as Novartis’ Luthatera which was given the green light by the EMA in 2017 and by the FDA in 2018. The interest in this type of treatment is significant and can be illustrated by Lutathera’s turnover, which in 2021 amounted to USD 475 million. Learn more.
With new targeted treatments, it is now possible to achieve very high precision in combination with the validated effect of radiation treatment. The next generation of radionuclide treatments includes Spago Nanomedical‘s candidate 177Lu-SN201. The candidate is part of the company’s Tumorad project, which is currently being prepared for an upcoming phase I/IIa study.
Positive preclinical results published
Recently, Spago Nanomedical published preclinical data regarding 177Lu-SN201 in the scientific journal ACS Omega.In the peer-reviewed article, the authorsdescribethecandidate’s composition, stability andmode of action.
In short, the results 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.
The preclinical results indicate that the candidate is well suited for systemic treatment of cancer.
Comments from the CEO
BioStock reached out to Spago Nanomedical’s CEO Mats Hansen to learn more about the published results and what they mean for the company.
Mats, radionuclide therapies have attracted a lot of interest lately, why is that?
Mats Hansen, CEO Spago Nanomedical
– Radiation therapy has been a cornerstone of cancer treatment for a long time. The possibilities of achieving endogenous radiation treatment were previously limited to specific cancers such as thyroid cancer and bone cancer.
– When Algeta’s Xofigo was approved about ten years ago, a new generation of targeted radionuclide therapies emerged. A major breakthrough came 5-6 years ago with Novartis’ Lutathera, a drug that has an annual turnover of almost USD 500 million in a specific group of patients with so-called neuroendocrine tumours.
– With today’s radionuclide therapies, the effectiveness of radiation treatment can be combined with high-precision targeting of tumours. This means that we can now treat tumours with radiation that was previously not possible to access. So far, however, the field is limited to a few tumour types which it is possible to target biologically.
– In this context, Tumorad could potentially further contribute to the area through its mechanism based on physiological targeting, which means that significantly more types of tumours could be treated.
What was the purpose of the preclinical studies, the results of which are now published?
– The results that have now been published in a peer-reviewed scientific journal provide an overall picture of the composition and mode of action of our drug candidate 177Lu-SN201.
– As the article describes how the nanoparticle’s chemical design provides a strong and sustainable binding of radioisotope, a favourable distribution in the body, as well as a good inhibiting effect on tumour growth and prolonged survival, it marks an end to the preclinical development phase and lays the foundation for further development in clinical studies.
In your press release, you mention that your candidate accumulates to a greater extent in tumours than Lutathera does – what does that mean for the project?
– The radioactive isotope in Lutathera, 177lutetium, is the same as we use in Tumorad. The fact that we can preclinically show that our candidate with the injected dose accumulates in at least as good a way as Lutathera gives a very significant indication of the possibilities of being able to treat cancer patients.
– As I mentioned earlier, Tumorad’s targeting is not dependent on binding to a specific protein that is expressed on the cancer cell you want to access, but that it accumulates physiologically in the tumour tissue via the EPR effect (Enhanced Permeability and Retention effect).
– This means that Tumorad can potentially be used as monotherapy or combination therapy in several cancers, even those that cannot be treated effectively today.
What are the implications from preclinical results for the preparation of the upcoming clinical study with Tumorad?
– These results, together with the favourable results from the regulatory toxicology studies we have conducted, strengthen the basis for our application to enter the clinic.
Finally, what is the current status of the Tumorad programme?
– Preparations for the phase I/IIa study are in full swing, for example, GMP manufacturing of the candidate is progressing according to plan, and we aim to submit an application for clinical trial shortly.