Spago’s CEO: Advancing the Tumorad programme comes first
Spago Nanomedical’s Q1 report signals steady progress with its radiopharma pipeline. Lead programme Tumorad recently got a boost by the release of positive non-clinical data in a triple-negative breast cancer model, incentivising the company to strengthen its management.
– 2024 has begun in the same positive spirit as we ended last year. Given the progress within both of our development programmes, we have seen a need to strengthen the company’s organisation, says Spago’s CEO Mats Hansen.
Radionuclide therapy (RNT) has been gaining steam as a promising mode of treatment for cancer. As recently reported by BioStock, big pharma companies like Novartis, Eli Lilly, AstraZeneca and Bristol Myers Squibb, are taking notice, and investors are pumping cash into the field in hopes of making a dent in the cancer toll.
Riding this wave, is Swedish biotech Spago Nanomedical. The company’s drug candidate 177Lu-SN201, which is part of Spago’s lead programme Tumorad, is currently being evaluated in phase I/IIa for advanced cancer. The first patient in the trial was dosed late last year, and in January, Spago announced receiving the approval for a dose-escalation study with 177Lu-SN201.
Spago makes progress in breast cancer model
According to Spago’s 2024 Q1 report, the company’s vision is to develop 177Lu-SN201 as an effective treatment for patients with aggressive cancers like ovarian cancer or triple-negative breast cancer.
After the reporting period, Spago announced favourable non-clinical data suggesting that 177Lu-SN201 has a statistically significant anti-tumour effect as monotherapy in a triple-negative breast cancer model.
– Triple-negative breast cancer is a very aggressive disease with poor prognosis. The current observations are therefore very promising and support further studies of 177Lu-SN201, says Spago’s CEO Mats Hansen.
The difference was measured in comparison to standard cancer drugs including immune checkpoint inhibitors, chemotherapy, and others. The model suggests that 177Lu-SN201 reduces tumour growth and significantly increases survival rate. The findings also show that the candidate induces low levels of radiotoxicity, suggesting a good safety profile.
– The current results are very encouraging, and we are looking forward to learn more about how 177Lu-SN201 may work synergistically with other drugs, said Spago’s CSO Oskar Axelsson.
In this extensive study, Spago is also exploring 177Lu-SN201 as a combination therapy in a 4T1 orthotopic triple-negative breast cancer model.
SpagoPix – improving imaging diagnostics
While Spago’s focus is on Tumorad, the company also advanced its imaging diagnostics project – SpagoPix – during the first quarter. 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. Analysis of study data showed that contrast enhancement could be observed in the majority of lesions confirmed by ultrasound, and thus the primary efficacy objective had been met. Read more here.
– The results show the potential of pegfosimer manganese in medical imaging of endometriosis lesions and enable further evaluation in the next step, says Mats Hansen.
Strengthened management team
Given the steady progress within both development programmes, Spago has decided to strengthen its management team. The company recently recruited Birgitta Rembratt Svensson as the new Head of CMC & Supply. She is an experienced CMC project manager with senior positions at pharmaceutical companies in the commercial phase and will join Spago Nanomedical’s management team in June.
– The recruitment to this key position is thus an important part in building a strong team with a focus on later development phases and commercialisation, says Mats Hansen.
CEO insights
BioStock reached out to Spago’s CEO to get his take on the company’s Q1 progress and what comes next.
Mats, Spago is exploring 177Lu-SN201 as both a monotherapy and as a combination therapy in a non-clinical setting. Could you tell us more about your strategy here?
– It is well known that radiation can trigger changes in tumour expression and composition and potentially open for new therapeutic avenues. We wanted to explore this in the Tumorad programme as a way to potentially open for improved treatment effect of currently approved pharmaceuticals with the addition of 177Lu-SN201.
How will this study impact the ongoing clinical study with 177Lu-SN201?
– The preclinical programme is run separately and in parallel with phase I of the ongoing clinical trial. Favourable results can facilitate clinical positioning of 177Lu-SN201 and support the final design of the phase IIa part of the trial.
What will be Birgitta Rembratt Svensson’s main role as Head of CMC & Supply?
– Procurement, planning, and execution of production and distribution will become increasingly important to supply our clinical studies with drugs and, in the longer term, prepare for commercial scale. Given the progress within both of our development programmes, the recruitment to this key position is an important part in building a strong team with a focus on later development phases and commercialisation. I am very pleased with the recruitment of Birgitta Rembratt Svensson as the new Head of CMC & Supply as she will bring broad managerial and technical experience in regulatory CMC and pharmaceutical development, both clinical and non-clinical, which will be of great importance in advancing our pipeline.
Finally, what will be Spago’s main focus for the rest of 2024?
– Advancing the Tumorad programme comes first, especially securing relevant phase I results and preparing for phase IIa. We will also continue to evaluate partnering opportunities and plan for next steps with SpagoPix, with emphasis on endometriosis.
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