Spago’s CEO: “We want to expand cancer treatment with effective radiopharmaceuticals”
2024 has marked a defining chapter for Spago Nanomedical, solidifying its position in radionuclide therapy. By focusing its energy on the lead Tumorad programme, the company achieved important milestones during the year. BioStock has spoken with CEO Mats Hansen to have him reflect on the past year and look ahead to 2025.
Spago Nanomedical is spearheading the development of Tumorad, a program where drug candidate 177Lu-SN201 utilises nanoparticles equipped with radioactive isotopes to enable radionuclide therapy against multiple cancer types.
Green light to continue Tumorad-01
A major milestone in 2024 was the positive recommendation from the Data Monitoring Committee (DMC), following treatment of the first patient cohort, to continue the phase I/IIa study Tumorad-01, evaluating 177Lu-SN201 in patients with advanced cancer. This was a critical step for Spago and bolstered confidence in 177Lu-SN201 as a potentially groundbreaking treatment for aggressive cancers, such as triple-negative breast cancer and others.
Strategic focus on Tumorad
To accelerate progress, Spago has strategically consolidated essentially all resources to the Tumorad programme, ensuring milestones are met on schedule. Recently, the company announced that all patients in the second cohort have been dosed, bringing the total numbers of patients in the study to six so far. This second group, consisting of three patients with various tumour types, will be evaluated in early 2025, offering valuable insights into the drug candidate’s safety and biodistribution. These findings are expected to bring important information for defining subsequent clinical development steps, with a first priority on generating efficacy data in the phase IIa part of the study. Meanwhile, patient recruitment continues to maintain the anticipated pace of enrolment.
Further SpagoPix development through partnerships
SpagoPix is the company’s second programme, focused on pegfosimer manganese for improved MRI visualisation of tumours and endometriosis. With clinical data supporting the platform’s potential, any further development of this program will occur through partnerships or grant funding.
Positioning the team for progress
Aligned with its strategic refocus, Spago has bolstered its leadership team during the year by appointing Birgitta Rembratt Svensson as Head of CMC and Supply. Her extensive pharmaceutical development and commercial production expertise add valuable capabilities to the company. With a sharpened organization aligned with the current development phase Spago is now well-positioned to bring important clinical results and effectively prepare for future regulatory development steps.
Questions for the CEO
BioStock spoke with CEO Mats Hansen about the past year and what 2025 offers.
Mats, what is your thoughts on the past year and the revised strategy?
– 2024 has been a crucial year in Spago’s development where we have achieved important clinical development steps with our therapeutic lead drug candidate 177Lu-SN201 while taking tough but important decisions to position the company for the future. In order to achieve clinical success and create shareholder value, the Board of Directors has adopted a strategy to focus the company’s resources primarily on the ongoing Phase I/IIa study Tumorad-01 and to discontinue all internal preclinical research. This strategy is expected to lead to significantly reduced costs and financial headroom to ensure results that can support the continued clinical development and prepare for the next phase of the Tumorad program.
What have been the most important milestones for the Tumorad program and the drug candidate 177Lu-SN201?
– The continued patient recruitment of the phase I/IIa study Tumorad-01 has been key. However, the recommendation in August by the independent Data Monitoring Committee (DMC) to proceed the study after the evaluation of the first three treated patients in the first cohort was a great achievement and enabled the continuation of the trial. Recently we were also very pleased to see that the second patient group has been successfully dosed and we are now awaiting the DMC’s analysis of this second group of patients early next year.
How does Spago view the competitive landscape in radionuclide therapies, and what sets 177Lu-SN201 apart from other candidates on the market?
– With Tumorad we want to expand treatment with effective radiopharmaceuticals. Our lead candidate 177Lu-SN201 is not dependent on molecular targeting, which may open for treatment of cancers that are not covered by approved or pipeline radiopharmaceuticals. Radioisotopes have repeatedly been proven to be effective against cancer and there is huge interest in the field with several Big Pharma companies taking positions. Yet relatively few tumor types are currently targeted and this is where Tumorad´s advantage may come in.
How are you positioned for challenges within regulatory and manufacturing going forward?
– With the updated strategy and organizational structure in place, we are well positioned for continued development work in the clinical phase as well as for regulatory and manufacturing requirements. The appointment of Birgitta Rembratt Svensson as Head of CMC & Supply earlier this year is an important piece of the puzzle in strengthening the internal competence of the company. Her experience from managing contract manufacturers and ensuring that all operations meet delivery and quality standards will play an important role as we take Tumorad into the next phase.
What are the key milestones Spago aims to achieve in 2025?
– Our main focus in 2025 will continue to be on the Tumorad program and the ongoing Phase I/IIa clinical study Tumorad-01. Although the next evaluation by the DMC is expected during the first quarter next, recruitment to the study continues with a clear focus on fulfilling a further objective of the protocol, recruiting patients with different tumor types. In line with the revised strategy, our aim is to generate results from the phase I part of the study during 2025, which will support decisions on the continued clinical development and start of the phase IIa part of the study. As the clinical development progress continues for the Tumorad program, we increase the pace of business development and will continue to meet new potential partners at meetings and partnering conferences. In parallel, active business development work is continuously underway to find potential partners or other solutions for the continued development of SpagoPix development program.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
