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Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

Thu, 15 May 2025 04:09:00 -0400

Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1).
Positive opinion paves the way for potential marketing authorization in the EU and EEA.
Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years).
In vivo data in murine models confirm preliminary safety and efficacy of

Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

Thu, 15 May 2025 04:09:00 -0400



Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1).
Positive opinion paves the way for potential marketing authorization in the EU and EEA.
Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years).
In vivo data in murine models confirm preliminary safety and efficacy of

Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

Thu, 15 May 2025 04:09:00 -0400



Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1).
Positive opinion paves the way for potential marketing authorization in the EU and EEA.
Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years).
In vivo data in murine models confirm preliminary safety and efficacy of

Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

Thu, 15 May 2025 04:09:00 -0400



Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1).
Positive opinion paves the way for potential marketing authorization in the EU and EEA.
Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years).
In vivo data in murine models confirm preliminary safety and efficacy of

Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

Thu, 15 May 2025 04:09:00 -0400



Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1).
Positive opinion paves the way for potential marketing authorization in the EU and EEA.
Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years).
In vivo data in murine models confirm preliminary safety and efficacy of

Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

Thu, 15 May 2025 04:09:00 -0400



Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1).
Positive opinion paves the way for potential marketing authorization in the EU and EEA.
Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years).
In vivo data in murine models confirm preliminary safety and efficacy of

Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

Thu, 15 May 2025 04:09:00 -0400



Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1).
Positive opinion paves the way for potential marketing authorization in the EU and EEA.
Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years).
In vivo data in murine models confirm preliminary safety and efficacy of

Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

Thu, 15 May 2025 04:09:00 -0400



Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1).
Positive opinion paves the way for potential marketing authorization in the EU and EEA.
Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years).
In vivo data in murine models confirm preliminary safety and efficacy of

China patent notification boosts PolTREG’s development of Treg cell therapy in multiple sclerosis

Mon, 16 Sep 2024 01:00:00 -0400

China’s National Intellectual Property Administration has issued notification to grant patent to PolTREG
Chinese patent covers intrathecal administration of PolTREG’s PTG-007 Treg cell therapy to treat multiple sclerosis
Intrathecal administration demonstrated promising result in Phase I clinical trial
PolTREG set to launch one Phase 2 study in each of two types of MS: relapsing-remitting (RRMS) and primary progressive (PPMS) in Q4 2024

Gdańsk, Poland – 16 September 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces that China’s National Intellectual Property Administration, PRC (CNIPA) has issued a

China patent notification boosts PolTREG’s development of Treg cell therapy in multiple sclerosis

Mon, 16 Sep 2024 01:00:00 -0400

China’s National Intellectual Property Administration has issued notification to grant patent to PolTREG
Chinese patent covers intrathecal administration of PolTREG’s PTG-007 Treg cell therapy to treat multiple sclerosis
Intrathecal administration demonstrated promising result in Phase I clinical trial
PolTREG set to launch one Phase 2 study in each of two types of MS: relapsing-remitting (RRMS) and primary progressive (PPMS) in Q4 2024

Gdańsk, Poland – 16 September 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces that China’s National Intellectual Property Administration, PRC (CNIPA) has issued a

China patent notification boosts PolTREG’s development of Treg cell therapy in multiple sclerosis

Mon, 16 Sep 2024 01:00:00 -0400

China’s National Intellectual Property Administration has issued notification to grant patent to PolTREG
Chinese patent covers intrathecal administration of PolTREG’s PTG-007 Treg cell therapy to treat multiple sclerosis
Intrathecal administration demonstrated promising result in Phase I clinical trial
PolTREG set to launch one Phase 2 study in each of two types of MS: relapsing-remitting (RRMS) and primary progressive (PPMS) in Q4 2024

Gdańsk, Poland – 16 September 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces that China’s National Intellectual Property Administration, PRC (CNIPA) has issued a

China patent notification boosts PolTREG’s development of Treg cell therapy in multiple sclerosis

Mon, 16 Sep 2024 01:00:00 -0400

China’s National Intellectual Property Administration has issued notification to grant patent to PolTREG
Chinese patent covers intrathecal administration of PolTREG’s PTG-007 Treg cell therapy to treat multiple sclerosis
Intrathecal administration demonstrated promising result in Phase I clinical trial
PolTREG set to launch one Phase 2 study in each of two types of MS: relapsing-remitting (RRMS) and primary progressive (PPMS) in Q4 2024

Gdańsk, Poland – 16 September 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces that China’s National Intellectual Property Administration, PRC (CNIPA) has issued a

China patent notification boosts PolTREG’s development of Treg cell therapy in multiple sclerosis

Mon, 16 Sep 2024 01:00:00 -0400

China’s National Intellectual Property Administration has issued notification to grant patent to PolTREG
Chinese patent covers intrathecal administration of PolTREG’s PTG-007 Treg cell therapy to treat multiple sclerosis
Intrathecal administration demonstrated promising result in Phase I clinical trial
PolTREG set to launch one Phase 2 study in each of two types of MS: relapsing-remitting (RRMS) and primary progressive (PPMS) in Q4 2024

Gdańsk, Poland – 16 September 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces that China’s National Intellectual Property Administration, PRC (CNIPA) has issued a

China patent notification boosts PolTREG’s development of Treg cell therapy in multiple sclerosis

Mon, 16 Sep 2024 01:00:00 -0400

China’s National Intellectual Property Administration has issued notification to grant patent to PolTREG
Chinese patent covers intrathecal administration of PolTREG’s PTG-007 Treg cell therapy to treat multiple sclerosis
Intrathecal administration demonstrated promising result in Phase I clinical trial
PolTREG set to launch one Phase 2 study in each of two types of MS: relapsing-remitting (RRMS) and primary progressive (PPMS) in Q4 2024

Gdańsk, Poland – 16 September 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces that China’s National Intellectual Property Administration, PRC (CNIPA) has issued a

PolTREG identifies promising efficacy biomarker for Type-1 diabetes in patients treated with its Treg therapy in combination with rituximab

Thu, 04 Apr 2024 01:00:00 -0400

New biomarker may facilitate monitoring T1D patients’ health
Increase in PD-1+ T-cells correlated with therapeutic response and less insulin use

Gdańsk, Poland – 4 April 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has published data in International Immunopharmacology which suggest that PD-1+ T-cells are a dependable biomarker for efficacy in pediatric early-onset Type-1 diabetes (T1D) patients, who had been successfully treated with PTG-007 Treg cell therapy, the company’s lead asset. The new results are from a two year immune-monitoring data follow-up

PolTREG identifies promising efficacy biomarker for Type-1 diabetes in patients treated with its Treg therapy in combination with rituximab

Thu, 04 Apr 2024 01:00:00 -0400

New biomarker may facilitate monitoring T1D patients’ health
Increase in PD-1+ T-cells correlated with therapeutic response and less insulin use

Gdańsk, Poland – 4 April 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has published data in International Immunopharmacology which suggest that PD-1+ T-cells are a dependable biomarker for efficacy in pediatric early-onset Type-1 diabetes (T1D) patients, who had been successfully treated with PTG-007 Treg cell therapy, the company’s lead asset. The new results are from a two year immune-monitoring data follow-up

PolTREG identifies promising efficacy biomarker for Type-1 diabetes in patients treated with its Treg therapy in combination with rituximab

Thu, 04 Apr 2024 01:00:00 -0400

New biomarker may facilitate monitoring T1D patients’ health
Increase in PD-1+ T-cells correlated with therapeutic response and less insulin use

Gdańsk, Poland – 4 April 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has published data in International Immunopharmacology which suggest that PD-1+ T-cells are a dependable biomarker for efficacy in pediatric early-onset Type-1 diabetes (T1D) patients, who had been successfully treated with PTG-007 Treg cell therapy, the company’s lead asset. The new results are from a two year immune-monitoring data follow-up

PolTREG identifies promising efficacy biomarker for Type-1 diabetes in patients treated with its Treg therapy in combination with rituximab

Thu, 04 Apr 2024 01:00:00 -0400

New biomarker may facilitate monitoring T1D patients’ health
Increase in PD-1+ T-cells correlated with therapeutic response and less insulin use

Gdańsk, Poland – 4 April 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has published data in International Immunopharmacology which suggest that PD-1+ T-cells are a dependable biomarker for efficacy in pediatric early-onset Type-1 diabetes (T1D) patients, who had been successfully treated with PTG-007 Treg cell therapy, the company’s lead asset. The new results are from a two year immune-monitoring data follow-up

PolTREG identifies promising efficacy biomarker for Type-1 diabetes in patients treated with its Treg therapy in combination with rituximab

Thu, 04 Apr 2024 01:00:00 -0400

New biomarker may facilitate monitoring T1D patients’ health
Increase in PD-1+ T-cells correlated with therapeutic response and less insulin use

Gdańsk, Poland – 4 April 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has published data in International Immunopharmacology which suggest that PD-1+ T-cells are a dependable biomarker for efficacy in pediatric early-onset Type-1 diabetes (T1D) patients, who had been successfully treated with PTG-007 Treg cell therapy, the company’s lead asset. The new results are from a two year immune-monitoring data follow-up

PolTREG identifies promising efficacy biomarker for Type-1 diabetes in patients treated with its Treg therapy in combination with rituximab

Thu, 04 Apr 2024 01:00:00 -0400

New biomarker may facilitate monitoring T1D patients’ health
Increase in PD-1+ T-cells correlated with therapeutic response and less insulin use

Gdańsk, Poland – 4 April 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has published data in International Immunopharmacology which suggest that PD-1+ T-cells are a dependable biomarker for efficacy in pediatric early-onset Type-1 diabetes (T1D) patients, who had been successfully treated with PTG-007 Treg cell therapy, the company’s lead asset. The new results are from a two year immune-monitoring data follow-up

PolTREG receives CGMP certification to produce cell therapies at its state-of-the-art manufacturing site in Poland

Mon, 11 Mar 2024 02:00:00 -0400

Gdańsk, Poland – 11 March 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has received CGMP certification from Poland’s Chief Pharmaceutical Inspectorate, allowing it to produce cellular therapies (Advanced Therapy Medicinal Products – ATMP) in its own site. The certification also enables it to seek permission from Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to perform clinical trials in the facility, for diseases such as Type-1 Diabetes (T1D) and Multiple Sclerosis (MS).

PolTREG was the first

PolTREG receives CGMP certification to produce cell therapies at its state-of-the-art manufacturing site in Poland

Mon, 11 Mar 2024 02:00:00 -0400

Gdańsk, Poland – 11 March 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has received CGMP certification from Poland’s Chief Pharmaceutical Inspectorate, allowing it to produce cellular therapies (Advanced Therapy Medicinal Products – ATMP) in its own site. The certification also enables it to seek permission from Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to perform clinical trials in the facility, for diseases such as Type-1 Diabetes (T1D) and Multiple Sclerosis (MS).

PolTREG was the first

PolTREG receives CGMP certification to produce cell therapies at its state-of-the-art manufacturing site in Poland

Mon, 11 Mar 2024 02:00:00 -0400

Gdańsk, Poland – 11 March 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has received CGMP certification from Poland’s Chief Pharmaceutical Inspectorate, allowing it to produce cellular therapies (Advanced Therapy Medicinal Products – ATMP) in its own site. The certification also enables it to seek permission from Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to perform clinical trials in the facility, for diseases such as Type-1 Diabetes (T1D) and Multiple Sclerosis (MS).

PolTREG was the first

PolTREG receives CGMP certification to produce cell therapies at its state-of-the-art manufacturing site in Poland

Mon, 11 Mar 2024 02:00:00 -0400

Gdańsk, Poland – 11 March 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has received CGMP certification from Poland’s Chief Pharmaceutical Inspectorate, allowing it to produce cellular therapies (Advanced Therapy Medicinal Products – ATMP) in its own site. The certification also enables it to seek permission from Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to perform clinical trials in the facility, for diseases such as Type-1 Diabetes (T1D) and Multiple Sclerosis (MS).

PolTREG was the first

PolTREG receives CGMP certification to produce cell therapies at its state-of-the-art manufacturing site in Poland

Mon, 11 Mar 2024 02:00:00 -0400

Gdańsk, Poland – 11 March 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has received CGMP certification from Poland’s Chief Pharmaceutical Inspectorate, allowing it to produce cellular therapies (Advanced Therapy Medicinal Products – ATMP) in its own site. The certification also enables it to seek permission from Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to perform clinical trials in the facility, for diseases such as Type-1 Diabetes (T1D) and Multiple Sclerosis (MS).

PolTREG was the first