A Unique Portfolio Targeting Major Indications

Spago Nanomedical develops nanomedical products for diagnostics and treatment of cancer. Main development activities are allocated to the projects SpagoPix and Tumorad®.

Spago Nanomedical's Pipeline

Spago is developing SpagoPix and Tumorad® in four different projects and indications; Breast Cancer, Pancreas, Solid tumors and Undisclosed indications. Before commercialization, a project will go through six different phases, starting with discovery.

SpagoPix is a nanomedical contrast agent for magnetic resonance tomography (MRI). The goal is more precise visualization of tumors than what is possible today. Initial clinical development is focused on breast and pancreas cancer.

Tumorad® enables internal radiation therapy of tumors, so called radiopharmaceutical treatment. With Tumorad®, the cancer patient can be more efficiently treated, with fewer side effects and less negative impact on quality of life. Initial clinical development of Tumorad® includes pre-targeting of patients with high likelihood of response by theranostic imaging in tumor indications with documented high EPR-effect.

Project & Indication
Discovery
Preclinical
Phase I
Phase II
Phase III
Commercial
SpagoPix – Breast cancer
SpagoPix – Pancreas
Tumorad® – Solid tumors
New Projects – Undisclosed indications

A Cancer Selective MRI Contrast Agent

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

SpagoPix - Improved Precision in Breast Cancer Diagnostics

Spago Nanomedical’s most advanced project is SpagoPix, a gadolinium-free MRI contrast agent for the diagnosis of solid tumors.

The SpagoPix project aims to launch a ground-breaking gadolinium-free MRI contrast agent for visualization of tumors and metastases. Unlike the conventional low molecular-weight MRI contrast agents, which enhance healthy tissue as well and therefore results in a relatively high proportion of false positive findings, Spago’s proprietary contrast agent is designed to selectively accumulate in tumor tissue. This improves the precision of MRI scans for suspected cancers.

Ongoing Trial in Breast Cancer Patients

With better cancer diagnostics, the chances of successful and cost-efficient treatment of cancer patients improve. In the currently ongoing SPAGOPIX-01 trial (ClinicalTrials.gov Identifier: NCT04080024), which aims at assessing safety and tolerability as well as initial efficacy of SpagoPix, the product candidate SN132D is administered to breast cancer patients at Uppsala university hospital and Sahlgrenska university hospital.

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.

After injection into the bloodstream, the competitors contrast agents for MRI (above) quickly diffuse from the circulation into tissues. The contrast between tumor and non-tumor is therefore relatively low.
After injection, SpagoPix (below) accumulates in tumor tissue but not in areas of the body where the circulatory system is intact. Thereby, the contrast between tumor and non-tumor is high.

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 – Improved Precision in Pancreatic Cancer Diagnosis

Pancreatic cancer remains one of the deadliest cancers worldwide. Due to a lack of early symptoms and a tendency to metastasize at an early stage, many patients with pancreatic cancer already have advanced disease at the time of diagnosis and therefore the mortality rate is high.

The five-year survival rate for pancreatic cancer is as low as 5%. To improve the patient survival rate, early detection is critical. A substantial clinical need is the identification and follow-up of pre-cancerous cysts or lesions. Improved imaging of pancreatic cancer would enable more optimal treatment and management decisions to be made. There is currently no MRI contrast agent specifically indicated for pancreatic cancer.

Clinical interim data from the SPAGOPIX-01 trial (NCT04080024) show excellent contrast in pancreas, and this opens up for this indication as an alternative target for the SpagoPix MRI contrast agent.

Efficient Radiation Treatment of Advanced Tumors and Metastases

Tumorad® provides the possibility of radiopharmaceutical treatment of advanced tumors and metastases as well as treatment of several types of solid soft tissue tumors.

Tumorad® - Particles Inhibit Tumor Growth and Extend Survival

Tumorad® provides the possibility of radiopharmaceutical treatment of advanced tumors and metastases as well as treatment of several types of solid soft tissue tumors.

In the Tumorad® development project, nanoparticles are loaded with radioactive isotopes providing the opportunity for radiopharmaceutical therapy against cancer. Tumorad® particles have been designed to utilize the EPR effect to achieve tumor selectivity, that is to say, a higher concentration of nanoparticles in tumors than in healthy tissue. Data from the aggressive mouse tumor model 4T1 confirm that Tumorad® particles accumulate in tumors, inhibit tumor growth and extend 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.

After injection into the bloodstream, Tumorad® accumulates in tumor tissue through the EPR-effect. The tumor is irradiated by a well-balanced therapeutic radiation dose whereas surrounding tissues are spared.

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