EASD24: PolTREG’s T-cell therapy achieves sustained remission in type 1 diabetes

Polish company PolTREG is advancing its cell therapy, PTG-007, for the treatment of type 1 diabetes by initiating a pivotal Phase II/III trial. The company is also seeking partnership funding to support this effort. The decision follows promising long-term data indicating that PTG-007 can induce clinical remission for type 1 diabetes for up to 12 years.

At the recent European Association for the Study of Diabetes (EASD) conference in Spain, PolTREG presented follow-up data from 54 patients with early-onset type 1 diabetes who participated in Phase I and II trials. These patients were monitored for 7-12 years after their initial treatment.

The results were encouraging, showing that some patients remained in clinical remission for up to 12 years following treatment. Clinical remission was defined as having a minimal need for external insulin while maintaining proper metabolic and glycemic control. A significant proportion of the patients remained insulin-independent for 18 to 24 months post-treatment.

Professor Piotr Trzonkowski, CEO of PolTREG, expressed optimism about the results, stating, "Today’s results are extremely encouraging and show that some patients remain in clinical remission for up to 12 years after initial treatment." He emphasized the company's eagerness to launch the pivotal study of PTG-007 once they secure a suitable partner.

The study also highlighted that the best outcomes were observed in patients who received a combination of Treg therapy along with Roche and Biogen’s anti-CD20 treatment Rituxan (rituximab). PolTREG plans to publish detailed data from the study in a peer-reviewed scientific journal.

In addition to the planned Phase II/III trial, PolTREG intends to initiate a Phase II trial to evaluate PTG-007 in patients with presymptomatic type 1 diabetes. This effort aligns with a broader trend in the field, as cell therapies are becoming increasingly popular for the treatment of type 1 diabetes. Last year, the US Food and Drug Administration (FDA) approved the first cell therapy, CellTrans’s Lantidra (donislecel), for the treatment of type 1 diabetes.

PolTREG's advancements are a part of a larger movement within the cell and gene therapy industry, which is gaining momentum and showing promise in transforming the treatment landscape for various diseases. The company aims to leverage this momentum by further exploring the potential of PTG-007 and expanding its clinical applications.