Second Cohort Dosed in Spago Nanomedical's Tumorad-01 Phase I/IIa Study

Lund, Sweden – On December 18, 2024, Spago Nanomedical, a company focused on advancing cancer treatment, announced the successful dosing of all participants in the second group of their Phase I/IIa clinical trial, Tumorad-01. This trial involves the experimental drug 177Lu-SN201, which is designed to treat cancer by delivering targeted radiation directly to tumor cells.

The Tumorad-01 study marks the first time 177Lu-SN201 is being tested in humans, with the primary goal of evaluating its safety, tolerability, and initial effectiveness. The study also aims to establish an appropriate therapeutic dose that can be used in subsequent phases. So far, six patients have been dosed with the candidate drug, with further analysis expected from the trial's independent Data Monitoring Committee (DMC) by the first quarter of next year.

Earlier in 2024, Spago Nanomedical confirmed that the initial group of three patients had been administered at least one dose of 177Lu-SN201. Following a review of the available data, the DMC recommended the continuation of the study. The second group, comprising two men diagnosed with lung and rectal cancer and one woman with throat cancer, has similarly received at least one treatment cycle. The DMC’s next evaluation is set to be revealed in the first quarter, while patient recruitment is ongoing.

Mats Hansen, CEO of Spago Nanomedical, expressed satisfaction with the trial’s progress, emphasizing the importance of evaluating 177Lu-SN201 across various types of cancer early in its development. He noted the inclusion of patients with five different cancers as beneficial for assessing the drug's potential in targeting multiple tumor types.

The development of 177Lu-SN201 builds upon previous clinical findings related to Spago Nanomedical’s nanoparticles, particularly the MRI contrast agent pegfosimer manganese (SN132D), which has shown promising results in breast cancer patients. The drug utilizes polymeric nanomaterials optimized to deliver the radioisotope lutetium-177 (177Lu), a substance already used in approved cancer treatments. This innovative approach positions 177Lu-SN201 as a potential new radioisotope therapy that could treat a broader range of tumors compared to existing radionuclide treatments.

A crucial part of the study involves demonstrating that 177Lu-SN201 can effectively target tumors without affecting other organs adversely. If successful, this drug could offer a significant advancement in cancer treatment, providing a more effective and focused therapy option.

Spago Nanomedical is a Swedish company dedicated to the clinical development of innovative treatments and diagnostic tools for cancer and other serious diseases. Their work is grounded in a platform of polymeric materials that possess unique properties, aiming for precise and effective medical solutions. The company's shares are publicly traded on the Nasdaq First North Growth Market.

As the Tumorad-01 trial progresses, Spago Nanomedical continues to explore the capabilities of their drug candidate, hoping to contribute a new and effective weapon in the fight against cancer.