Tor 2 dec / År 39 / Nr 4 2021

Nanomedicine innovators improving diagnosis and treatment of cancer

Based in Lund in Sweden, Spago Nanomedical is developing products for cancer diagnosis and treatment based on chemistry and nanomedicine. Founded in 2007, Spago’s aim is to move products through to the market with support from strategic partners.

Spago Nanomedical develops nanomaterials for improved cancer diagnostics and treatment, and it grew around an invention that was based on the use of gadolinium-based nanoparticles as a contrast agent for MRI. However, after the finding that gadolinium was linked with a serious and non-treatable side effect, nephrogenic systemic fibrosis, in patients with impaired kidney function, the company moved towards a focus on manganese, which had high-contrast enhancement on MRI. In 2011, this became the basis for the company’s imaging product SpagoPix. In 2014, Spago began development of its next product, the tumour-selective radionuclide therapy Tumorad®.

Selective cancer imaging with SpagoPix
SpagoPix, Spago Nanomedical’s cancer selective MRI contrast agent, is moving into its first clinical trial. The nanoparticles are tumour-selective because of the enhanced permeability and retention (EPR) effect in tumours, a phenomenon leading to accumulation of particles of a certain size in tumour tissue. The study will include around 20 breast cancer patients and will document the product’s safety and ability to enhance MRI images. Production of GMP-grade SpagoPix is underway with the contract manufacturing organization ChemConnection, and the study is planned to start by the end of the year.
“We are drafting a protocol with our CRO, the Swedish company CTC,” said Mats Hansen, CEO. “The main study objectives are to investigate safety of SpagoPix as well as ability to improve MR images in breast cancer patients. Our aim is to outlicense SpagoPix based on clinical data, and any early proof-of-principal results from this study will steer our licensing discussions. As well as providing funding, this could begin our shift towards becoming a therapeutics company.”
SpagoPix’s clinical development has been supported by a SEK500,000 grant from Sweden’s government agency for innovation, Vinnova.

Moving forward as a therapeutics company
Now SpagoPix is moving into clinical trials, Spago can move its focus to Tumorad®, which is made up of nanoparticles loaded with radionuclides. Tumorad® could have therapeutic potential in a range of soft tissue tumours, and may be complementary or even synergistic with other approaches to cancer treatment such as immunotherapy.
“Tumorad development has suffered a bit from our focus on SpagoPix. As a small organisation we had to focus on one product initially. As SpagoPix is now in the hands of a CRO, we can spend more time on Tumorad,” said Hansen.
The company’s aim is to design nanoparticles that have a half-life in vivo that matches that of the radioisotope.
“We are close to a prototype,” said Hansen, “and we plan to start a preclinical proof-of-concept study as soon as possible.”
In addition, Spago may also carry out phase 0 microdose trials with Tumorad, where very small doses are used that can still be traced. This would get the agent into the clinic and generate pharmacokinetic data from humans at an early stage.