A Unique Portfolio Targeting Major Indications

Spago Nanomedical develops nanomedical products for diagnostics and treatment of life-threatening and debilitating diseases. Main development activities are allocated to the projects SpagoPix and Tumorad®.

Spago Nanomedical's Pipeline

The following table summarizes the development stage and status of Spago Nanomedical’s project pipieline:

Project & Indication
Phase I
Phase II
Phase III
New Projects – Undisclosed indications

SpagoPix aims to bring a nanomedical contrast agent for magnetic resonance tomography (MRI). Available clinical results in breast cancer support the platform technology and provide for improved imaging precision and visualization of tumors than what is possible today. Initial clinical development is focused on indications with a clear medical need for improved imaging.

Tumorad® enables internal radiation treatment of tumors, so called radionuclide therapy (RNT). The aim is to bring precision RNT for effective treatment of cancer, stand-alone or in combination with other therapies. Clinical development of Tumorad® includes a theranostic imaging approach for selection of patients with high likelihood of response in tumor indications with documented high EPR-effect.

A Selective MRI Contrast Agent

SpagoPix has the potential of significantly improving diagnostics through earlier, enhanced and more precise visualization.

SpagoPix - Improved Precision in MRI

In SpagoPix we develop a gadolinium-free MRI contrast agent for precision imaging of solid tumors and other severe diseases.

The SpagoPix project aims to launch a ground-breaking gadolinium-free MRI contrast agent, SN132D, for improved visualization of tumors and other lesions. Unlike the conventional low molecular-weight MRI contrast agents, which enhance healthy tissue as well as diseased and therefore results in a relatively high proportion of false positive findings, SN132D is designed to selectively accumulate in diseased tissue. This could contribute to improved precision in MRI scans, e.g. for suspected cancers.

SPAGOPIX-01 Clinical Trial in Breast Cancer Patients

With better precision in imaging, the chances of successful and cost-efficient treatment of cancer patients could improve. The aims of the SPAGOPIX-01 trial (ClinicalTrials.gov Identifier: NCT04080024), was to assess safety and tolerability as well as initial efficacy of SN132D  in breast cancer patients. The trial was conducted at Uppsala university hospital and Sahlgrenska University Hospital in Sweden. Interim clinical data from the first two dosage groups show that SN132D provides imaging with selective contrast in breast tumors, without compromising safety (Wärnberg et al., 2022, Abouhany et al., 2022). In addition SN132D show excellent contrast in pancreas and liver, opening for broader use in imaging of these organs.

FACTS – Breast Cancer and MRI

Based on statistics released by the WHO in late 2020 with around 2.3 million new cases, breast cancer has now overtaken lung cancer as the world’s most commonly diagnosed cancer. In Sweden, one out of every nine women develops breast cancer before the age of 75. When detected early, the possibilities of successful breast cancer treatment are very good, and survival rates are therefore high. In many cases however, and especially in low-and mid-income countries, the breast cancer is often diagnosed at an advanced stage when the cancer has already spread and is usually incurable.

Image-based technologies that are used to diagnose cancer include mammography, ultrasound, computed tomography (CT), positron emission tomography (PET) and magnetic resonance imaging (MRI). MRI is primarily used within breast cancer diagnostics to provide in-depth knowledge of the localization and spread of the tumors before surgical treatment, and as a follow-up instrument to assess the outcome of treatment. One of the advantages of MRI compared with, e.g., CT and PET, which are other highly sensitive alternatives for tumor detection, is that MRI does not involve the use of ionizing radiation which in itself is a risk factor for cancer.

While MRI has significant potential to improve cancer diagnostics, the method as it is currently used has limitations which hinders the full exploitation of this sensitive means of cancer imaging. One of them is that the contrast agents which are necessary to enhance tumor contrast in the MRI imaging cannot satisfactorily distinguish cancer from non-cancer tissue which leads to a high proportion of false positive findings (tumor findings that are not malignant). False positive findings lead not only to anxiety and suffering for the individual patient, but also to significant costs for subsequent unnecessary examinations. Another factor reducing the potential for MRI is a correlation found between the use of gadolinium-based contrast agents and accumulation of gadolinium, in tissues including the brain. It is not clear whether these gadolinium deposits are harmful, but this has had a major impact on the use of these contrast agents, with authorities in the EU and the US (EMA and FDA respectively) deciding to completely ban many gadolinium-based contrast agents, or in some cases severely limit their use.

Benefits of SpagoPix

allows high resolution images of the tumor to be captured. The MRI signal from SpagoPix is built up over several hours which is an advantage when several images need to be captured or when an MRI scan is performed. This is not possible when gadolinium-based contrast agents are used since they leave the body in a couple of minutes.

SpagoPix has several times higher relaxivity in measurements than other contrast agents on the market. New data is showing that the relaxivity of the SpagoPIx product candidate SN132D is among the highest measured for an MRI contrast agent.

Thanks to the combination of the tumor-selective mode of action and the high signal strength, SpagoPix can provide a clearer and more precise image of the tumor. This reduces the risk of so-called false positive findings, which is a significant improvement over the existing contrast agents that often result in misdiagnosis.

The risk of adverse effects from use of gadolinium, foreign to the body, is eliminated. SpagoPix uses manganese to enhance the signal in an MRI examination. Manganese is an essential element that occurs in many of our most common food and is needed to maintain good health. When manganese is bound to other substances as in SpagoPix, there is significantly reduced risk of negative impact due to high dosage.

SPAGOPIX-02 Clinical Trial in Endometriosis

SPAGOPIX-02 (ClinicalTrials.gov Identifier: NCT05664828) is an open label, proof-of-concept study concerning efficacy of SN132D in patients with suspected endometriosis. The study will include up to 18 patients and is led by Associate Professor Dr. Ligita Jokubkiene, Senior Consultant at the Department of Obstetrics and Gynecology at Skåne University Hospital in Malmö, Sweden. The study will evaluate the safety and MRI enhancing properties of SN132D in participants with suspected endometriosis. Comparisons will be made to transvaginal ultrasound and conventional MRI in order to consider the diagnostic potential of SN132D in endometriosis.

Nanomedical Radionuclide Therapy of Advanced Tumors and Metastases

Tumorad® provides the possibility of one radiopharmaceutical treatment against several types of solid soft tissue tumors, as monotherapy or in combination with other treatments.

Tumorad® - Preclinical Results Support Clinical Translation

Bringing possibilities for radiopharmaceutical treatment of advanced tumors and metastases as well as treatment of several types of solid soft tissue tumors.

In the Tumorad® project, nanoparticles are loaded with radioactive isotopes providing the opportunity for radionuclide therapy against cancer. The candidate drug 177Lu-SN201 has been optimally designed for physiological targeting by means of the EPR effect. Preclinical results from different tumor models confirm accumulations in tumors, inhibited tumor growth and extended survival.

FACTS – Radiopharmaceutical Therapy

One in 5 people will develop cancer during their lifetime. Recent statistics show that the overall number of people diagnosed with cancer has nearly doubled in twenty years, from an estimated 10 million in 2000, to nearly 20 million diagnosed cases in 2020. Forecasts suggest that this number will continue to grow with an additional 50% in the coming 20 years.

Despite important advances and new therapies, the number of deaths from cancer is also on the rise. With around 10 million fatal cases in 2020, cancer is the cause of one out of every six deaths. Survival rates are specifically poor when the cancer has spread. Treatment resistance is a significant challenge in cancer care, and there is therefore a clear clinical need for new treatment alternatives.

Radiation treatment is one of the cornerstones of cancer treatment. Usually, an external radiation source is used to target the tumor from the outside, but it is also possible to utilize pharmaceuticals bearing radioactive isotopes – radiopharmaceuticals, that accumulate in the tumor after the injection into the blood stream. The latter has been used successfully in some specific cancers for a long time and can be a valuable alternative or complement to other types of treatment, especially in advanced or aggressive cancers. One example is treatment of thyroid cancer with radioactive iodine, where a cure can be achieved despite extensive spread. One of the main benefits of radiopharmaceutical therapy compared to other systemic therapy, such as chemotherapeutic agents, is the potential to show efficacy while keeping toxicity low.

Benefits of Tumorad®

The local accumulation of Tumorad® opens for delivery of an adapted radiation dose sufficient to treat the tumors while minimizing undesirable effects on surrounding tissue. This also allows treatment of several types of solid soft tissue tumors.

Local radiation: The advantage of radiopharmaceutical therapy compared to external beam radiation is its ability to selectively deliver radioactivity to tumors and thereby irradiate multiple soft tissue tumors or metastases simultaneously. The technology also enables irradiation of tumors that could not otherwise be treated with external beam radiation, such as deeper situated tumors or tumors adjacent to vital organs.

Easy radiolabeling and preparation for facilitated handling in the clinic.

Based on dosimetry analysis following a diagnostic Tumorad® dose, it is possible to calculate tumor versus non-tumor uptake and therefore the likelihood of treatment success for an individual patient.

Enables combination treatments with other therapies for optimised efficacy