Encouraged by positive preclinical data with Tumorad, Spago Nanomedical has intensified preparations for the upcoming phase I/IIa study in cancer patients. The company also reported advancements with the contrast agent SpagoPix. BioStock reached out to CEO Mats Hansen for a comment on the Q1 report.
First North-listed Spago Nanomedical’s projects are based on a technology platform with functional nanoparticles. The company is developing a new radionuclide treatment for cancer, Tumorad and a new contrast agent for magnetic resonance imaging (MRI), SpagoPix.
Tumorad towards phase I/IIa
In Tumorad, Spago is preparing the drug candidate 177Lu-SN201 for an upcoming phase I/IIa study. The trial in cancer patients is planned to be conducted in Australia. During the first quarter, Spago finalised the study protocol and agreements with CROs to carry out the study.
A significant risk reduction in the project was achieved when completing the large-scale GMP production of the study material of the candidate. Spago is now awaiting approval from Australian authorities to initiate the study.
Advancements with SpagoPix
Last year, Spago completed the phase I study SPAGOPIX-01 with contrast agent candidate SpagoPix in breast cancer. The company presented favourable results at San Antonio Breast Cancer Symposium. SpagoPix is tolerable, and safe and provides clear contrast enhancement in MRI images of solid tumours. The company is now working on the final study report.
At the same time, SpagoPix is evaluated in a phase IIa study in endometriosis at the Skåne University Hospital. Early observations were presented at the 15th World Congress on Endometriosis in Edinburgh. The observations support further study recruitment. Preliminary results from the study are expected around the mid-year.
Financial statement for Q1
As the activities have intensified, the company reported higher costs in Q1, as previously predicted by CEO Mats Hansen. The company reported an operating loss of 14,6 MSEK and an operating cash flow of 15,8 MSEK for the first quarter. The cash balance amounted to 45,1 MSEK by the end of Q1.
Changes in the Board
At the Annual General Meeting on May 10th, Spago made changes to the Board. Hans Arwidsson was elected the new chair and Alan Raffensperger was elected a new member of the Board. Both new board members have extensive experience from leading positions in the life science industry.
Comments from the CEO
BioStock talked with Mats Hansen about the report and the latest news.
Mats, much of your focus is on the upcoming phase I/IIa study with Tumorad. What is the current status of the project?
– With previous positive clinical data of our contrast agent SN132D supporting the targeting mechanism of our platform, and preclinical results that suggest the Tumorad candidate drug 177Lu-SN201 is effective in treatment of against aggressive tumours, the project is now ready for trials in humans.
– We are expecting to start the phase I/IIa study within short. In addition we just recently also completed the GMP-production of the carrier particle, SN201, which we consider a major risk-reduction in this phase.
– We are excited about the potential of Tumorad as a new radiopharmaceutical that may be used in treatment of several cancer indications either as monotherapy or in combination with current or future therapies.
Why have you chosen Australia for the study?
– We see great potential for cost effective conduct of the first in human study in Australia as we can expect substantial refunds from the Australian government for clinical R&D activities.
– The regulatory process for study approval is also less extensive compared to Europe and Sweden which means we are able to start the trial earlier. An additional benefit is the access to local supplier of radioisotope and services related to radiolabelling.
– Following study initiation in Australia we aim to expand the trial to sites in Europe also.
Turning to SpagoPix, could you update us on the latest activities in this project?
– We are wrapping up results of the phase I trial SPAGOPIX-01 and work to finalise the study report. This will also be followed by publication in a scientific journal.
– In parallel, the clinical phase IIa trial in patients with endometriosis is ongoing and we aim to conduct a first interim analysis shortly. At that point we should be able to communicate results from the first group of patients.
Finally, at the AGM, a new chairman and a new board member were elected. How would you comment on these additions to the company?
– We are very happy to welcome both Hans Arwidsson and Alan Raffensperger as chairman and non-executive director, respectively. With their extensive experience I am confident they will make valuable contributions and bring positive energy.
– I would also like to sincerely thank Eugen Steiner, Peter Leander, and Sten Nilsson for their work and commitment to Spago Nanomedical over the years, and I am pleased that both Sten and Peter remain as medical advisors to the company.
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