Spago Nanomedical Updates on Tumorad-01 Trial Progress

May 20, 2024 / Spago Nanomedical AB announced today that both clinical sites involved in the Tumorad-01 phase I/IIa study are actively recruiting patients. Presently, two patients have been successfully enrolled and dosed, while a third patient is enrolled and preparing for treatment, and a fourth patient has been identified. The focus of the study remains on recruiting patients with diverse tumor types, and the study is progressing as planned.

Tumorad-01 is a phase I/IIa first-in-human clinical trial aimed at evaluating the safety, tolerability, dosimetry, and initial efficacy of the investigational drug 177Lu-SN201 in patients with advanced cancer. The phase I portion of the study is designed to determine a potential therapeutic dose based on safety and biodistribution, which will then be further tested in selected patient groups during phase IIa.

To date, two male patients with metastatic castration-resistant prostate cancer (mCRPC) have successfully completed the initial dosing of 10 MBq/kg without experiencing any serious adverse events (SAEs). The third and fourth patients, both female, have different types of tumors and are awaiting or preparing for treatment.

The next meeting of the Data Monitoring Committee (DMC) is scheduled to take place after the first treatment cycle has been completed by all three patients in the initial cohort. During this meeting, the DMC will review all available safety, pharmacokinetics, biodistribution, and dosimetry data. The company plans to provide an update on the initial study data following the DMC's evaluation.

CEO Mats Hansen expressed satisfaction with the progress of the Tumorad program's first-in-human study. He noted the active recruitment efforts at the Australian sites and looked forward to the DMC's evaluation and recommendations upon the completion of the initial patient cohort. Hansen emphasized the company's commitment to furthering the study in line with its objectives by continuing to recruit patients with various tumor types.

Spago Nanomedical has previously demonstrated selective tumor accumulation of its functional nanoparticles in clinical settings. This was shown using the MRI contrast agent pegfosimer manganese (SN132D) in breast cancer patients. The Tumorad candidate drug 177Lu-SN201 builds on this technology by combining the optimized polymeric nanomaterial with lutetium-177 (177Lu), a clinically effective radioisotope already used in approved drugs. The aim is to develop 177Lu-SN201 as a promising radionuclide therapy for selective cancer treatment across multiple tumor types. If the study can demonstrate favorable radiation biodistribution to tumors over other organs, 177Lu-SN201 could become an effective cancer treatment.

This update aligns with Spago Nanomedical's goal to maintain market transparency during the exercise period for warrants of series TO12, which runs from May 17 to May 30, 2024. The company has previously communicated that it could raise approximately SEK 25.5 million before issuance costs if all TO12 warrants are fully utilized. These funds are primarily intended to secure results from the phase I part of the Tumorad-01 study and support decisions regarding the focus and initiation of the phase IIa part of the study.

Spago Nanomedical AB, based in Sweden, is in the clinical development phase. The company's projects are founded on a platform of polymeric materials designed for precise cancer and other serious disease treatments and diagnoses. Spago Nanomedical's shares are listed on Nasdaq First North Growth Market under the ticker SPAGO.

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