101  0 Kommentare Spago Nanomedical Interim Report January-March 2024

• Nothing to report

SIGNIFICANT EVENTS AFTER THE QUARTER

• Spago Nanomedical strengthens management by the appointment of Birgitta Rembratt Svensson as Head of CMC & Supply. Birgitta, an experienced CMC project manager with several leading positions at development and commercial stage pharmaceutical companies, will join Spago Nanomedical on June 1 and serve as a member of the management team.
• 177Lu-SN201 demonstrates significant anti-tumor effect in a non-clinical triple-negative breast cancer model compared to several cancer drugs with a low and acceptable level of radiotoxicity observed.

CEO STATEMENT
2024 has begun in the same positive spirit as we ended last year. The phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201 is progressing according to plan with a continued satisfactory safety profile. New and promising non-clinical effect data in a triple-negative breast cancer model further strengthens our belief in Tumorad in the treatment of several different types of cancer. As we take Tumorad further into the clinic, we have also strengthened the management team with an experienced Head of CMC & Supply.

Our ongoing phase I/IIa clinical study Tumorad-01 is a first-in-human study with the primary aim of evaluating safety, tolerability, dosimetry and initial effect of 177Lu-SN201 in cancer patients with the aim of identifying a possible therapeutic dose for further studies. In January, we announced that the first patient was successfully treated with the initial dose and the study has since continued as planned.

The phase I part of the study aims to, based on safety and biodistribution, identify a possible therapeutic dose for further testing in selected patient groups in the phase IIa part. Based on preclinical results, we assess that there is a good chance of a favorable benefit-risk profile in humans. Using different methods to measure radioactivity in the body, even at low doses, we expect to be able to get an early idea of the possibilities for therapeutic usefulness in cancer patients. Patient recruitment continues and our ambition is to further update the market regarding the study before mid-year.