The submitted abstract was accepted to the 56^th ANZSNM Annual Scientific Meeting, this year themed ‘From Concept to Cure: Transforming Healthcare with Nuclear Medicine’ for an oral presentation. The abstract was accepted to the Research in Progress category based on the ongoing clinical trial Tumorad-01. The conference constitute an excellent opportunity to raise awareness of Tumorad within the nuclear medicine community and to present ad hoc exploratory imaging data observed at the author, Associate Professor Kim Taubman’s, site at St Vincent’s Hospital.

The ongoing first-in-human study Tumorad-01 evaluating safety, tolerability, dosimetry and early signs of efficacy of ¹⁷⁷Lu-SN201 in patients with advanced solid tumors where no standard treatment options exist.

“The acceptance of this abstract reflects the growing scientific interest in the Tumorad program and the potential of ¹⁷⁷Lu-SN201 as a new radiopharmaceutical treatment approach for patients with advanced cancer,” said Mats Hansen, CEO of Spago Nanomedical. “The data generated to date support the continued clinical development of Tumorad and provide the basis for further evaluation of Spago’s nanomedicine platform.”

¹⁷⁷Lu-SN201 is a β-emitting radiopharmaceutical nanoparticle designed to accumulate in tumors through the Enhanced Permeability and Retention (EPR) effect, a physiological phenomenon associated with tumor angiogenesis that allows nanoparticles to accumulate in tumor tissue. This opens up the possibility of treating cancer independent of receptor expression and molecular targeting. In the Tumorad-01 study, visible tumor uptake of ¹⁷⁷Lu-SN201 has been observed with SPECT imaging, including significant uptake in a patient with adenoid cystic carcinoma treated with one cycle of the drug candidate. The observed tumor uptake supports Tumorad's mechanism in humans and indicates potential for therapeutic exposure by means of delivery of the medically proven isotope lutetium-177 (¹⁷⁷Lu). The Data Monitoring Committee (DMC) considers the observation to be proof-of-concept for Tumorad, indicating that ¹⁷⁷Lu-SN201 may be a potential new treatment for cancer.

The ongoing Tumorad-01 trial is an open-label, multicenter, dose-escalation and expansion study enrolling adult patients with progressive or treatment-refractory locally advanced, unresectable or metastatic solid tumors. Participants may receive up to three treatment cycles and undergo safety assessments and imaging-based dosimetry using SPECT/CT. The primary objectives of the Phase I part of the study are to evaluate safety and tolerability, determine dose-limiting toxicities and identify a recommended Phase II dose or maximum tolerated dose. Secondary objectives include pharmacokinetics and dosimetry analyses. The dose escalation is guided by a Bayesian Optimal Interval (BOIN) design.

To date, a total of 14 patients with advanced cancer have been dosed in the study, and the DMC has confirmed that the safety profile remains acceptable with no dose limiting toxicities observed to date.