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Gdańsk, Poland – March 11, 2024 – PolTREG S. A. (Warsaw Stock Exchange: PTG), a clinical-stage biotechnology company developing mobile therapeutics for a variety of autoimmune diseases, today announces that it has obtained CGMP certification from Poland’s Chief Pharmaceutical Inspectorate, allowing it to produce advanced therapy medicines (ATMPs) at its own site. The certification also allows you to apply for authorization from the Polish Registration Office for Medicines, Medical Devices and Biocides (URPL) to conduct clinical trials at the center, for diseases such as type 1 diabetes (T1D) and sclerosis (MS).
PolTREG was the first company in the world to administer T-reg treatments to patients and the first to start receiving benefits from its main product under a hospital exemption valid in Poland. Its production facility is one of the largest and most complex in Europe. , with more than 2,100 m² of laboratory, adding 15 production lines. PolTREG has the opportunity to especially expand its facilities to enable the manufacture of state-of-the-art technical treatments and mobile treatments from long-term partners. The company now has more than 17 years of experience treating patients, having administered Treg mobiles to more than a hundred people at that time, either through hospital exemption procedures or through clinical trials.
“This certification is vital proof of PolTREG’s roles in the manufacture of mobile therapeutics, a very complicated procedure that requires a great deal of expertise to master,” said Prof. Piotr Trzonkowski, CEO of PolTREG. ” From our logo and new installations, you can now send those mobiles live anywhere in Europe within 24 hours. This is a significant prospective expansion of remedy functions for patients and vital care as our portfolio of Treg mobile remedies moves closer to the market.
PolTREG has developed one of the most complex lines of Treg treatments for autoimmune diseases, with polyclonal and engineered mobiles. Its lead candidate, PTG-007, is in mid-term clinical studies for two indications in Type 1 diabetes and two in MS. Tregs, the company plans to launch a first-in-human trial for two neurodegenerative diseases (MS and amyotrophic lateral sclerosis (ALS)) in early 2025. It is also in the preclinical phase with two other modified mobile types.
About PolTREGPolTREG is a global leader in the progression of regulatory T cell-based (Treg)-based autoimmune treatments. Its lead product, PTG-007, an autologous Treg remedy for early-onset type 1 diabetes (T1D), is in position for Phase 2/3 clinical trials, for which the company is seeking a partnership. The company will initiate Phase 2 trials of PTG-007 for the treatment of multiple sclerosis (MS) in the second half of 2024 for RRMS and PPMS. PolTREG has also evolved Tregs, adding CAR-Tregs, antigen-specific Tregs and TCR-Tregs, in the preclinical phase. PolTREG has conducted 4 clinical trials with more than one hundred patients treated with Tregs.
For more information, visit www. poltreg. com.
For information, please contact:
PolTREG S. A. Prof Piotr TrzonkowskiDirector généralir@poltreg. com 512 532 401
Investor RelationsChris MaggosCohesion Office 41 367 62 54chris. maggos@cohesionbureau. com Media Relations Douwe MiedemaCohesion Office 352 621 562 764douwe. miedema@cohesionbureau. com
The contents of this announcement include statements that are, or could conceivably be considered, “forward-looking statements. “These forward-looking statements can be made known by using forward-looking terminology, adding the words “believes,” “estimates,” “anticipates,” “expects,” “intends,” “potentially,” “will,” “will,” “plans,” “continues,” “ongoing,” “potential,” “predicts,” “projects,” “targets,” “seeks” or “should” and come with statements made through the Company relating to the expected effects of its strategy. By their nature, forward-looking statements involve dangers and uncertainties and readers are cautioned that such forward-looking statements are not promises of long-term performance. The Company’s actual effects could possibly differ materially from those expected in the forward-looking statements. The Company assumes no legal responsibility to publicly update or revise any forward-looking statements, as required by law. .
Attached you
20240311 PolTREG PR CGMP certification – according to GNW