PolTREG SA, a Warsaw Stock Exchange listed pioneering clinical-stage biotechnology firm specializing in cellular therapies targeting autoimmune ailments, has disclosed pivotal findings in International Immunopharmacology indicating PD-1+ T-cells as a reliable biomarker for assessing efficacy in pediatric early-onset Type-1 diabetes (T1D) patients treated with PTG-007 Treg cell therapy, the company's flagship asset. This revelation stems from a comprehensive two-year immune-monitoring analysis encompassing 36 participants who underwent a randomized, placebo-controlled Phase 1/2 clinical trial. Remarkably, preceding data unveiled that 50% of PTG-007-treated subjects, concomitant with rituximab, remained in remission even after 24 months.

PolTREG's CEO, Piotr Trzonkowski, a co-author of the aforementioned scholarly manuscript, expressed enthusiastic anticipation regarding the potential of polyclonal Treg therapies, affirming the company's commitment to advancing treatment paradigms. Trzonkowski underscored the significance of PD-1+ T-cells as an efficacy indicator, emphasizing its pivotal role in refining therapeutic monitoring strategies. Leveraging insights gleaned from extensive patient interactions spanning 17 years, PolTREG underscores the transformative impact of their unique therapeutic approach, epitomized by the utilization of real-world patient data to inform product innovation and trial design.

The crux of the Phase 1/2 investigation, elucidated in a 2022 publication, underscored the superiority of combined autologous T-regulatory cell (Treg) and rituximab therapy over monotherapy in T1D management. The current study, aiming to delineate immune profiles, delineated significant associations between clinical responses and heightened levels of PD-1+ T-cells across Treg and T-effector cell subsets, alongside modulated humoral immunity. Furthermore, augmented PD-1 receptor expression correlated with favorable treatment outcomes, including reduced insulin requirements, advocating for its role as a prognostic marker. Monitoring PD-1+ T-cell dynamics emerges as a pivotal facet in facilitating therapeutic surveillance.

Elevating its commitment to therapeutic innovation, PolTREG boasts a leading-edge pipeline encompassing both polyclonal and engineered Treg therapies, with PTG-007 spearheading mid-stage clinical assessments targeting T1D and multiple sclerosis (MS). Anticipating groundbreaking strides, the imminent launch of a first-in-human trial for engineered CAR-Tregs heralds a transformative era in addressing neurodegenerative maladies. Bolstered by its state-of-the-art GMP-certified manufacturing infrastructure, PolTREG stands at the vanguard of cellular therapy, epitomizing excellence in therapeutic innovation and patient-centric care.