All Patients Successfully Treated in ProTrans-Young Study

June 13, 2025

NextCell Pharma AB ("NextCell" or the "Company") announces today that all patients in the ongoing ProTrans-Young clinical trial have now successfully been treated. This milestone marks the completion of patient dosing in the company’s largest clinical study to date. ProTrans-Young is evaluating the safety and efficacy of the Company’s lead cell therapy candidate, ProTrans, in paediatric and adolescent patients with recently diagnosed type 1 diabetes.

“We are pleased to have completed treatment of all patients in the ProTrans-Young study,” said Mathias Svahn, CEO of NextCell Pharma. “This is an important milestone in our mission to develop a disease-modifying therapy for children with type 1 diabetes. We are very impressed by the work of the study teams and deeply grateful to the participating patients and their families for their trust.”

ProTrans-Young is an investigator-initiated Phase II clinical trial led by Professor Per-Ola Carlsson at Uppsala University, in collaboration with Linköping and Lund Universities. The trial began with an open-label safety phase in which six children received ProTrans, three aged 12–18 years and three aged 7–11 years, followed by three months of safety follow-up. This was followed by a randomised, placebo-controlled, double-blinded phase including 30 patients aged 12–21 years, allocated 1:1 to receive either ProTrans or placebo. One-year follow-up results for this group were reported in April 2025 and showed a positive trend in preserved insulin production. However, many patients in both arms remained in remission at the one-year mark, longer than initially expected, making it difficult to observe the full treatment effect at this stage. Based on previous adult trials, the differences between treatment groups are expected to become more pronounced over time as remission naturally ends.

The final cohort of 30 patients aged 7–11 years has now also been treated, with randomisation 1:1 to receive either ProTrans or placebo. This marks the completion of all dosing within the ProTrans-Young trial. One-year follow-up data from the full study population are expected after the summer of 2026.

The ProTrans platform is based on allogeneic mesenchymal stromal cells (MSCs) selected using NextCell’s proprietary algorithm to identify cells with optimal immunomodulatory function. ProTrans is being developed as an off-the-shelf, single-dose infusion therapy aimed at modulating the immune system and preserving residual beta cell function in autoimmune diabetes.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 5595
E-mail: info@nextcellpharma.com

Websites:
NextCell Pharma AB: www.nextcellpharma.com
Cellaviva Sverige: www.cellaviva.se
Cellaviva Danmark: www.cellaviva.dk
QVance AB: www.qvance.se

LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma

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About NextCell Pharma AB
NextCell Pharma is a clinical-stage cell therapy company developing ProTrans, a patent-protected platform based on allogeneic mesenchymal stromal cells (MSCs) from umbilical cord tissue. Using a proprietary selection algorithm, ProTrans delivers optimised cell tailored to specific indications. In type 1 diabetes, a single infusion has been shown to preserve insulin production and delay disease progression for at least five years. A Phase III trial is planned to commence upon securing a commercial partner. ProTrans is also being evaluated for other autoimmune and inflammatory conditions. NextCell’s subsidiaries include Cellaviva, Scandinavia’s largest private stem cell bank, and QVance, the Nordic region’s first dedicated provider of quality services for developers of advanced therapies.

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