Spago Nanomedical recently received approval to start the phase I/IIa study with Tumorad in Australia. The study is now well on its way as the company announced last week that the first patient has been successfully dosed. BioStock reached out to Spago’s Chief Development Officer Paul Hargreaves to learn more.

Radioisotope cancer treatments offer targeted therapy, delivering radiation directly to cancer cells. This precision aims to minimise damage to healthy tissues. Additionally, radioisotopes can be used for imaging which could aid clinical development for early establishment of therapeutic dosing.

Spago Nanomedical’s Tumorad candidate drug 177Lu-SN201 is based on a type of polymeric nanomaterial combined with the effective radioisotope lutetium-177 (177Lu), which is clinically validated and is already used in market-approved drugs.

According to the Swedish biotech, this makes 177Lu-SN201 a promising new radionuclide therapy for tumour-selective treatment of cancer with potential use in multiple tumour types.

Preclinical data have backed up Spago’s belief in the candidate, showing increased targeting accuracy and reduced side effects. Read more here.

All this has led Spago to pursue clinical evaluation of 177Lu-SN201 and initiate the Tumorad-01 study.

Tumorad clinical study has begun

Tumorad-01 is designed to enable early data demonstrating safety, biodistribution and accumulation of 177Lu-SN201, as well as its initial efficacy in tumours of patients suffering from advanced cancer. In October, the company received approval from the Australian authorities to start a phase I/IIa trial.

Last week, Spago announced that the first patient has been dosed in the trial. This means that the phase I part of the study, designed to identify a possible therapeutic dose for further evaluation, is 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.

Q&A with the CDO

BioStock reached out to Spago’s CDO Paul Hargreaves to learn more about the study and his expectations moving forward.

Paul, how does it feel to have this study underway?

– We are of course very excited to have this first clinical study with our radionuclide therapy program Tumorad ongoing and to have the first patient successfully dosed. The study start marks the transition into clinical development of Tumorad and is a very important milestone for Spago Nanomedical.

– There is still a great medical need for more effective methods to treat metastatic and aggressive cancer. Radionuclide therapy has become increasingly common and an effective treatment option for cancer. With several clinical advantages, compared to other radioisotope drugs, we believe 177Lu-SN201 has good potential to become an effective drug against cancer.

Could you give us more specifics about the aim of this study and what you hope to learn about Tumorad?

– Tumorad-01 is a phase I/IIa, dose escalation and dose expansion, first-in-human study in patients with advanced cancer with the primary aim to evaluate safety, tolerability and initial efficacy of the drug candidate 177Lu-SN201. The phase I part of the study will include up to 30 cancer patients with the aim to identify a possible therapeutic dose based on safety and biodistribution, to be further tested in selected groups of patients during the phase IIa part. With a favourable distribution of radiation to tumours versus the rest of the body, 177Lu-SN201 has good potential for becoming an effective drug against cancer,

This is the first of up to 30 patients to be dosed in this part of the study. What is your strategy for patient recruitment and how challenging will it be to recruit all necessary patients?

– For the initiation of the study we have carefully selected two sites with excellent experience of radiopharmaceutical clinical trials. The sites together have a total catchment area of over 6 million individuals. We have designed the study with patients at the front of our minds, trying to make the procedures and visit schedule as easy as possible. The sites are provided close support from Spago and our partners to make the study as smooth as possible. Lastly, both sites have large numbers of patients that are already eligible due to their advanced cancers for the study.

– It is also important to mention that the study design is adaptive. This means that as long as there are no safety issues, we can escalate doses rapidly. In the end, this could mean we need significantly less than 30 patients to complete the phase I part of the study.

Spago’s CEO Mats Hansen talks about the benefit at this point of having an open study design. What does he mean by that?

– An open study design will allow for continuous data reporting during the study, versus a blinded study where you need to dose a specific number of patients before you can evaluate the data. And there is no placebo group to consider, which means the total number of patients can be lower.

– We are expecting initial data showing the biodistribution and accumulation of 177Lu-SN201 in tumours of cancer patients early in the phase I part of the study. These early data are expected to validate previous preclinical modelling and to identify a clinically relevant therapeutic dose for further testing in selected patient groups in the phase IIa part of the study. With this study design we will be able to maintain a time- and cost-effective approach using our available resources in the best possible way.

Finally, could you give us some specifics about the expected timeline for this study?

– As a first-in-human study, the recruitment will follow careful dose-escalation and safety monitoring in the first part of the study at each dose level. As confidence increase, the recruitment can be accelerated to a point where we either reach a toxicity limit, or we have enough data to conclude on a therapeutic dose for the phase IIa part of the study.

– We expect to have the first initial data regarding safety and biodistribution already in the first half of next year, and we aim to be able decide on how to proceed in the phase IIa approximately a year after that.

Prenumerera på BioStocks nyhetsbrev