The company recently reached an important milestone with its contrast agent SpagoPix and, if the results are positive, it could enhance cancer care.

Spago Nanomedical was founded in 2007 as a subsidiary of Accelerator Nordic. The purpose was to advance an invention from the University of Linköping regarding the use of gadolinium-based nanoparticles as a contrast agent for MRI. A few years later, in 2011, the company initiated the development of a novel nanomaterial for MRI-contrast that instead of gadolinium was based on manganese. The material showed a high contrast enhancement in MRI and also had tumor-selective properties. Today it is this patented nanomaterial that is the basis of the company’s development project, called SpagoPix.

In 2014 the company also initiated a project named Tumorad, in which a nanomaterial is loaded with radioactive isotopes to create a nanomedical product for tumor-selective radionuclide therapy.

Things are starting to happen

Last year was quite an eventful year for the company. For example, the United States Patent and Trademark Office (USPTO) granted the company’s patent application comprising product protection for Tumorad in the USA. The patent is valid until the year 2035. The approval means that Spago Nanomedical holds product protection for Tumorad in one of the strategically most important markets for radionuclide therapies.

Perhaps even more interesting, in December the company applied to the Swedish Medical and Pharmaceutical Agency for initiation of a phase I clinical trial of SpagoPix (SN132D) in patients with breast cancer.

A milestone

In February 2019 the company received approval from the Swedish Medical and Pharmaceutical Agency and could initiate its first clinical study with SpagoPix. It has taken time for the company to mature its project into clinical studies, so the decision was a historic one for the company.

“It was a great joy that after a long period of hard work and pressure on the entire organization we received a positive result. Both the project and the company have matured and it will be very inspiring to take them further to commercialization,” says Mats Hansen, CEO of Spago Nanomedical.

The primary aim of the clinical trial is to document safety. Another key aim is to investigate the contrast enhancement in MRI of primary and secondary tumors. Pre-clinical studies have shown promising results, such as better image contrast, which enables detection of smaller tumors. The trial, which is planned to include up to 20 patients, will be conducted at the Uppsala University Hospital.

“SN132D is a new and interesting contrast agent for MRI examination of solid tumors, a field in need of improvements,” says Fredrik Wärnberg, responsible investigator for the SPAGOPIX-01 trial and senior physician at Uppsala University Hospital.

Data by the end of the year

Mats Hansen says that the goal is to have data from the study by the end of the year.

“A positive result from this trial would foremost be a validation of our technology and our ability to drive projects into clinical phase. Business-wise it is of course also a strength to be able to lean on clinical data during discussions with potential partners for out-licensing,” he says.

In February 2019 Klas Palin, Equity Analyst at Redeye, valued the Spago base case at 18 SEK, which increases to 26 SEK if there are clear positive results.

“A positive result would mean a significant risk reduction in the project and a value increase for potential partners. The risk in the phase I study is significantly lower than traditional pharmaceutical development, since the transformation between human and animal models is higher,” he stated in his analysis. If there are negative results, he sat the value to 5 SEK.

Photo of Mats Hansen and SpagoPix: Emil Aaltonen,

Facts

SpagoPix

The advantages with SpagoPix are that it may more easily differentiate tumors from other tissues in the body. This significantly decreases the risk for wrongful tumor findings. It will also give more distinct images, and with that there are larger opportunities to detect and provide a correct cancer diagnosis.

Tumorad

Tumorad is a therapy project with the purpose of treating, and not diagnosing, cancer. The project uses the same nanoparticles but the largest difference is that the Tumorad particles are larger and contain a radioactive isotope instead of manganese. The isotope irradiates the cancer tumor.