PolTREG Therapy for Type-1 Diabetes Shows Long-Term Remission and Insulin Independence

PolTREG S.A., a biotechnology company at the clinical development stage, has revealed promising data regarding its Treg cell therapy, PTG-007, for treating type-1 diabetes (T1D). According to the company, this therapy resulted in clinical remission of the disease for some patients for a period extending up to 12 years. A subset of these patients also remained insulin-independent for as long as 18 to 24 months post-treatment. This data was showcased at the INNODIA EASD symposium held in Madrid.

The CEO of PolTREG, Prof Piotr Trzonkowski, emphasized the significance of these results, noting the life-long challenges faced by individuals with type-1 diabetes. He highlighted that PTG-007 could potentially liberate many patients from the constant need for insulin injections and the associated long-term complications of the disease. Prof Trzonkowski expressed eagerness to commence a pivotal study of PTG-007 as soon as a suitable partner is found, believing that the therapy has a transformative potential for T1D patients.

The clinical study involved monitoring 54 patients who participated in Phase I and Phase II trials of PTG-007, focusing on those with early-onset T1D, over periods ranging from 7 to 12 years. Key findings included that a segment of the participants remained insulin-independent for up to 24 months after receiving the treatment, while some maintained clinical remission for up to 12 years. Clinical remission was characterized by a reduced need for external insulin while maintaining satisfactory metabolic and glycemic control.

The study reported the most favorable outcomes in patients who received Treg therapy alongside a standard anti-CD20 treatment, such as rituximab. This was determined by measuring the patients' insulin levels after consuming a standardized liquid meal. Comprehensive analysis of over 700 variables, including heart function, microcirculation, kidney health, liver function, endocrine system activity, and fertility, showed no inferiority in patients treated with Tregs compared to those receiving standard care. Additionally, no severe adverse effects were observed from the Treg cell treatment.

PolTREG is preparing to publish the study in a peer-reviewed scientific journal to provide full data disclosure. The long-term safety and efficacy results of the Treg therapy presented at the symposium offer a competitive advantage for the company. PolTREG plans to initiate a pivotal Phase 2/3 study of PTG-007 for T1D, pending partnership funding.

The company has one of the most extensive pipelines of Treg therapies for autoimmune diseases, encompassing both polyclonal and engineered therapies. PTG-007, an autologous polyclonal Treg treatment, is in mid-stage clinical trials for T1D and multiple sclerosis (MS). PolTREG will commence a Phase 2 study in presymptomatic T1D patients later this year. Next year, the company aims to start its first human trial of an engineered CAR-Treg based on the PTG-007 platform for MS and amyotrophic lateral sclerosis (ALS). Additionally, PolTREG is developing two further types of engineered Treg cells in preclinical stages.

PolTREG manufactures all its Treg therapies at its own GMP-certified production facility, which is among the largest and most advanced in Europe, covering over 2,100 sqm of laboratory space with 15 production lines. The company is also pioneering in administering Treg therapies to patients and has begun earning revenue from these treatments under hospital exemptions in Poland. PolTREG has potential plans to further expand its facility to support next-generation engineered therapies and cell treatments and can distribute its cellular therapy products across Europe within 24 hours.

PolTREG is a recognized global leader in developing autoimmune therapies using T-regulatory cells (Tregs). Its leading product, PTG-007, aimed at early-onset Type-1 Diabetes (T1D), is poised for Phase 2/3 clinical trials, for which the company seeks a partnership. The company will also initiate Phase 2 trials for PTG-007 in treating Multiple Sclerosis (MS) in late 2024, targeting both RRMS and PPMS. PolTREG's pipeline includes advanced engineered Tregs, such as CAR-Tregs and antigen-specific Tregs, in preclinical development. PolTREG has completed four clinical trials, treating over 100 patients with Tregs.

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