Home News Spago’s phase I/IIa cancer trial progressing steadily

Spago’s phase I/IIa cancer trial progressing steadily

 Spago’s phase I/IIa cancer trial progressing steadily

Spago’s phase I/IIa cancer trial progressing steadily

15 January, 2024

The positive momentum for Spago Nanomedical carries over into 2024 as the company announces continued progress with its Tumorad phase I/IIa trial. The independent data monitoring committee has recommended a dose escalation with the company’s radiopharmaceutical drug candidate 177Lu-SN201 for the treatment of advanced cancer.

Spago Nanomedical had a strong 2023, culminating in the approval and consequent start of a phase I/IIa trial with the promising radiopharmaceutical 177Lu-SN201 as part of the Tumorad project.

The drug is based on a type of polymeric nanomaterial combined with the effective radioisotope lutetium-177 (177Lu), which is clinically validated and is already used in market-approved drugs. According to the Swedish biotech, this makes 177Lu-SN201 a promising new radionuclide therapy for tumour-selective treatment of cancer with potential use in multiple tumour types.

Preclinical data have backed up Spago’s belief in the candidate, showing increased targeting accuracy and reduced side effects. Read more here.

Spago’s Tumorad dose escalation approved

In October, Spago received the approval to commence the Tumorad-01 study from the ethics review committee at St. Vincent’s Hospital in Melbourne. Patient recruitment followed immediately thereafter, and in December the first patient was dosed. This marked a major milestone for Spago, and the company’s CDO Paul Hargreaves gave BioStock more details about the study in this interview.

Safety data from this first patient shows no concerns, according to Spago. The company has announced that the independent data monitoring committee has recommended stepping up the dosage of 177Lu-SN201 from 10 MBq/kg to 25 MBq/kg. The aim with this first part of the trial is to test the candidate’s safety and tolerability.

This is in line with the goal of the phase I part of the study, which is to identify, based on safety and biodistribution, a possible therapeutic dose for further testing in selected patient groups in the phase IIa part of the study. According to Spago, patient recruitment is proceeding according to plan and initial data from the phase I part of the study is expected to be reported later in the first half of 2024.

A rising star in the field of RNT

So-called radionuclide therapy (RNT) is quickly becoming a valid alternative or complement to existing cancer treatments, and Spago is quickly carving a space for itself in the field. Its Tumorad project is among its most promising ventures, demonstrating a fusion of nanotechnology and oncology to address some of the most pressing challenges in cancer care. Read more about Tumorad’s potential here.

Expectations are high, and BioStock will be following the Lund-based company closely.

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