Spago Nanomedical AB is prioritizing its Tumorad program, specifically advancing the clinical study of its candidate drug, 177Lu-SN201. This strategic decision involves focusing resources on the ongoing Phase I/IIa study, Tumorad-01, to achieve crucial clinical milestones and enhance shareholder value.
Tumorad-01: Evaluating 177Lu-SN201 in Cancer Patients
The Tumorad-01 study is designed as a first-in-human trial to assess the safety, tolerability, dosimetry, and initial efficacy of 177Lu-SN201 in cancer patients. The Phase I portion of the study aims to determine a potential therapeutic dose for further evaluation in selected patient groups during Phase IIa. In August 2024, Spago Nanomedical reported successful treatment of the first patient group with at least one dose of 177Lu-SN201.
Following a review of available data, including safety, tolerability, biodistribution, and dosimetry, the independent Data Monitoring Committee (DMC) recommended continuing the study as planned, with the inclusion of patients with various tumor types. No serious adverse events (SAEs) were reported, and the DMC deemed the safety profile satisfactory for this patient group. Patient recruitment is progressing at two clinical sites, with the next DMC evaluation anticipated after the subsequent cohort of three patients completes their initial treatment cycle.
Strategic Shift and Resource Allocation
To support the Tumorad program, Spago Nanomedical will discontinue internal preclinical discovery activities. This move is expected to significantly reduce costs, allowing the company to concentrate on generating results that will inform decisions regarding the continued clinical development of 177Lu-SN201 and prepare for the next phase of the Tumorad program.
"Spago Nanomedical is in a new phase with full focus on the development of our candidate drug against cancer, 177Lu-SN201," said CEO Mats Hansen. "The plan established is crucial to advance and accelerate the development of our leading Tumorad program."
SpagoPix Program Update
The SpagoPix development program, featuring the product candidate pegfosimer manganese, aims to enhance the precision of MRI scanning for suspected endometriosis and cancer. Clinical results have demonstrated clinically relevant contrast in breast cancer tumors, the liver, and the pancreas, with a good safety profile. Selective contrast enhancement has also been observed in endometriosis lesions during a Phase IIa clinical trial. Future clinical development of the SpagoPix program will be pursued in collaboration with a partner through out-licensing, commercial collaborations, or other grants. The company is actively seeking potential partners to advance the program.
