Spago Nanomedical strengthened management to reflect project progress
The clinical phase I/IIa study evaluating radiopharmaceutical candidate 177Lu-SN201 in solid tumours has been progressing steadily for Spago Nanomedical. This progress has led the company to put more focus on regulatory priorities. As part of this, the company recently strengthened its management team by adding Birgitta Rembratt Svensson as Head of CMC and Supply. BioStock reached out to Birgitta to learn more about her role and how it complements the company’s new phase of development.
Spago Nanomedical is quickly gaining ground in the radionuclide therapy (RNT) field. Their phase I/IIa first-in-human study (Tumorad-01) in patients with advanced cancer is well underway. The primary objective of the trial is to evaluate the safety, tolerability, dosimetry and initial efficacy of the candidate drug 177Lu-SN201. This first step in the clinic should provide Spago with crucial information regarding a possible therapeutic dose for further studies.
During Q2 of this year, Spago announced that two patients, both men with metastatic castration-resistant prostate cancer (mCRPC), successfully completed initial dosing. No serious adverse events were reported in those patients. A third patient, a woman with metastatic breast cancer, has also been treated, marking the completion of the first group of patients expected for this study.
Green light to continue phase I/IIa trial
Last week, Spago announced that the independent Data Monitoring Committee (DMC), after analyzing the data from the frist three patients, was satisfied with the safety profile of the drug candidate. The committee recommended the continuation of the study based on that analysis. This means that Spago can continue with the second cohort of patients, as planned. The next step is to recruit three additional patients with different tumour types.
Tumorad’s progress means that Spago emphasize priority on regulatory development phase. The company is putting more focus on being able to surpass the requirements that are expected as Tumorad’s clinical development proceeds.
Strengthened management team for Spago
This shift in focus has led Spago to strengthen its management team. Earlier this year, the company recruited Birgitta Rembratt Svensson as Head of CMC and Supply. Birgitta joins from the Danish commercial stage pharmaceutical company MC2 Therapeutics where she was CMC Project Manager from 2021. Previous positions include Head of Development at Sever Pharma Solutions and Bioglan, respectively. Birgitta holds a PhD in physical chemistry and a MSc in chemistry from Lund University.
A conversation with Birgitta Rembratt Svensson
BioStock reached out to Birgitta to learn more about her and her priorities as Spago moves into the next phase of development.
Birgitta, what attracted you to Spago?
– Spago is in a very exciting phase accelerating the Tumorad program in the clinics. When I was first contacted by Spago the preparations for the phase I/IIa study Tumorad-01 with 177Lu-SN201 were ongoing at full speed and the first patients were about to be recurited. And now we have reached another milestone when DMC recommended continued patient recruitment and expansion to patients with different tumor types. Besides the high pace and agile workflow in a smaller company, the fact that Tumorad-01 is a first-in-human study evaluating Spago’s unique approach, combined with the potential to be able to increase the therapeutic outcome for hard to treat cancers, are very attractive.
What makes you a good fit for the company?
– As an experienced CMC project manager with several senior positions at pharmaceutical companies in the commercial phase, I believe I will provide valuable contributions when our clinical studies progress and preparation for commercial scaling are about to start.
Could you give us a specific example from your past experience that you believe best prepared you for this new role?
– For many years, I have successfully led cross-functional teams in pharmaceutical contract development and manufacturing organizations, known as CDMOs. My extensive expertise in GMP production with these vendors has uniquely prepared me to address the challenges Spago now faces as we approaches a regulated late-stage product development phase.
Could you tell us more about what entails Spago’s increased focus on regulatory activities?
– Initiating and conducting clinical studies always include extensive regulatory work including far-reaching interactions with regulatory authorities, and Spago is no exception. We are now progressing with the Tumorad-01 clinical trial and the recruitment pace is increasing with another activated hospital. Assuming that the phase I part of the study proceeds as planned and a possible therapeutic dose is identified, the next step is to start preparing for the phase II part of the study where further testing in selected patient groups will take place.
What are going to be your main goals as Head of CMC and Supply?
– My goal is to ensure that Spago develops high-quality, safe, and effective products while, advancing them through the clinical stages. I am committed to meeting all regulatory requirements with the right quality at the right time. I will achieve this through teamwork and by implementing tools to guide employees and stakeholders through various operations, from manufacturing, quality control, and supply chain management.
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