In 2023, Swedish biotech Spago Nanomedical kicked off its journey in the clinic with radionuclide cancer therapy Tumorad. Ending the year with the first patient dosed in the phase I trial and a SEK 30.6 million capital raise, Spago has strong momentum going into 2024. BioStock spoke with Spago’s CEO Mats Hansen to hear about the progress made in 2023 and what he is most looking forward to this year.

Radionuclide therapy (RNT) is quickly becoming a valuable alternative or complement to existing cancer treatments, especially in cases of aggressive cancers. The idea is to use nanoparticles to selectively target tumour tissue and facilitate local radiation without affecting healthy tissue. This type of therapy is the basis for Spago Nanomedical’s Tumorad project, where the clinically validated radioisotope Lutetium-177 is combined with Spago’s functional nanoparticles, forming Spago’s candidate ¹⁷⁷Lu-SN201.

Spago’s Tumorad project moves into the clinic

During 2023, the Swedish company took significant steps to bring Tumorad to the clinic. After receiving the approval for a phase I/IIa study from Australian authorities in October, Spago quickly moved forward and announced dosing the first patient in December. This means that the phase I part of the study, designed to identify a possible therapeutic dose for further evaluation, is well underway.

Up to 30 patients will be dosed in this part of the trial before deciding on a dose for phase IIa for selected patient groups. But according to Spago’s CDO Paul Hargreaves, who spoke with BioStock regarding the study in this interview, it important to keep in mind that the study design is adaptive; meaning that dose escalation can happen quickly, as long as there are no safety issues. “This could mean we need significantly less than 30 patients to complete the phase I part of the study.”

According to Spago’s recently released 2023 year-end financial report, initial safety and biodistribution data from the phase I part of the study are expected in the first half of 2024.

Positive top-line data in SpagoPix programme

While Spago’s focus is on the Tumorad project, the company also made a key advancement within its imaging diagnostics project – SpagoPix. Here, Spago is developing a new gadolinium-free contrast agent, pegfosimer manganese, for improved MRI diagnostics.

The agent has been evaluated in a phase IIa study in suspected endometriosis patients. Top-line data released late last year indicates that contrast enhancement with pegfosimer manganese was observed in the majority of lesions confirmed by unenhanced ultrasound. This means that the primary endpoint was met, and the company is evaluating what steps to take next. According to Spago’s CEO Mats Hansen, who commented on the results in a BioStock interview, the company expects “to have the final results published in one or several appropriate scientific journals and at scientific conferences later this year.”  Read more here.

Strong momentum looking ahead

To round things out in the fourth quarter of 2023, Spago Nanomedical carried out a fully guaranteed rights issue that provided the company with approximately SEK 30.6 million before issue costs. This will ensure smooth progress for the company’s clinical programmes, and it will help the company take further steps towards its goal of disrupting the cancer therapy landscape.

As development moves forward for Spago, the company is seeing increased interest in its programmes. This is driven, in part, by the heightened attention to growing RNT field, as evidenced by some major transactions in the last few years. According to a survey by analyst firm GlobalData, transactions in the field have increased significantly in recent years. For example, Eli Lilly invested USD 175 million in Mariana Oncology‘s preclinical project MC-339 for small cell lung cancer, and at the end of December they acquired all shares in the radiopharmaceutical company Point Biopharma for approximately USD 1.4 billion.

Another example comes from Bristol Myers Squibb’s acquisition of RayzeBio and its radiopharmaceutical platform for approximately USD 4.1 billion.

Read more about the large potential of radiopharmaceuticals here.

CEO insights

To get a full overview of Spago’s plans moving forward, BioStock spoke with CEO Mats Hansen.

Mats, looking back at 2023, how would you summarise the year for Spago?

– 2023 was successful year with several important milestones achieved in both of our programmes. Most important was of course that we took the Tumorad programme into clinical development phase and started of our first clinical study, Tumorad-01, in Australia with the primary objective of evaluating safety, tolerability, dosimetry and initial efficacy of the drug candidate 177Lu-SN201. The first cancer patient in the phase I/IIa study was successfully treated with the initial dose in December and the patient recruitment is ongoing according to plan.

– Significant progress has also been made in our second development programme, SpagoPix, where we reported positive topline data in December from the clinical phase IIa study SPAGOPIX-02 with the contrast agent pegfosimer manganese, formerly known as SN132D, in patients with suspected endometriosis. The results demonstrate the potential of the contrast agent in medical imaging of endometriosis lesions and enable further evaluation in the next step.

– During the last quarter we also carried out a fully guaranteed rights issue that provided the company with approximately SEK 30.6 million before issue costs.

How will you use the proceed from this capital raise?

– The last funding was very important to Spago as we now can take the Tumorad programme further into clinical development, enabling us to continue enrolling the up to 30 cancer patients for the phase I part of the study. With an open study design that allows for continuous data reporting, we expect initial data demonstrating the biodistribution and accumulation of 177Lu-SN201 in tumours in cancer patients early in the study, probably already in the first half of 2024. These data will be of great importance as they can give an indication of the utility of the compound in cancer patients and identify a possible therapeutic dose for further testing in selected patient groups in the phase IIa part of the study.

You were in San Franscisco in connection with the annual J.P. Morgan Health Care conference in January. Could you share your experience from there?

– It was a few busy days in San Francisco in the beginning of the year with several fruitful business meetings and new contacts established. We noticed an increased interest for our research and several pharmaceutical companies are definitely keeping an eye on us, especially after the announcement of the recent positive topline data in endometriosis with SpagoPix. There is a growing interest in women’s health in general, and endometriosis in particular, among pharmaceutical companies. Women suffering from endometriosis are a severely under-diagnosed and under-treated patient group and the need for improvement is very high.

Finally, what goals have you set for 2024??

– The main goal in 2024 is to take Tumorad further into the clinic. Upon success in the phase I part of the study and identified therapeutic dose, we will proceed towards the phase IIa part of the study in selected groups of cancer patients. In parallel, we will continue business development activities aimed at finding partners for the SpagoPix programme.

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