Spago Nanomedical AB (publ) announced that the first cancer patient has successfully been dosed in the clinical phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201. Initial data regarding safety and biodistribution from the phase I part of the study is expected to be reported already in the first half of 2024. Tumorad-01 is a phase I/IIa first-in-human study in patients with advanced cancer with the primary objective of evaluating safety, tolerability, dosimetry and initial efficacy of 177Lu-SN201.

The phase I part of the study was designed for up to 30 cancer patients and aims to, based on safety and biodistribution, identify a possible therapeutic dose for further testing in selected patient groups in the phase IIa part of the study. The study is initially run at a number of clinics in Australia and as the study progresses, clinics in other countries may also be included. Clinical evidence of selective tumor accumulation of Spago Nanomedical's functional nanoparticles has previously been generated with the MRI contrast agent SN132D in breast cancer patients.

In the Tumorad candidate drug 177Lu-SN 201, the same type of carefully optimized polymeric nanomaterial is combined with the effective radioisotope lutetium-177 (177Lu), which was previously used in market approved drugs. This makes 177Lu-SN201 a promising new radionuclide therapy for tumor-selective treatment of cancer with potential use in multiple tumor types. The Tumorad-01 study is designed to enable early data demonstrating safety, biodistribution and accumulation of 177Lu-SN201 in tumors in cancer patients.

With a favorable distribution of radiation to tumors compared to other organs, 177Lu-SN201 has good potential to become an effective drug against cancer.