PolTREG

18/12/2025

Nobel Lecture by Dr. Mateusz Gliwiński, MD, PhD – PolTREG S.A. & Gdański Uniwersytet Medyczny (Medical University of Gdańsk).

The second lecture in the Nobel Lectures series at the Faculty of Chemistry, Uniwersytet im. Adama Mickiewicza w Poznaniu, was delivered by Dr. Mateusz Gliwiński, MD, PhD (PolTREG S.A. & Gdański Uniwersytet Medyczny (Medical University of Gdańsk), who shared his scientific and expert knowledge in the field of immunology.

Lecture topic: “Tregs – how not to be (eaten) by your own immune system”. In summary, the lecture explained how regulatory T cells (Tregs) maintain immune system balance and why they are crucial in preventing autoimmunity. It also highlighted the therapeutic potential of Tregs, including their application in autoimmune diseases and type 1 diabetes.

PolTREG S.A. is a biotechnology company focused on the development of innovative cell therapies based on regulatory T lymphocytes (Tregs) for the treatment of autoimmune diseases.

Pictures source: https://chemia.amu.edu.pl/wydzial/aktualnosci-wydzialowe/relacja-z-drugiego-wykladu-noblowskiego-dr.-n.-med.-mateusza-gliwinskiego

15/12/2025

PolTREG S.A. on Strefa Inwestorów - Praktycznie o inwestowaniu

During the Skuteczny Inwestor 2025 conference, Paweł Biedrzycki interviewed Prof. Piotr Trzonkowski and Mariusz Jablonski - a conversation particularly relevant for investors analyzing the biotech sector.

Key topics discussed:
- the significance of this year’s Nobel Prize in Medicine and its impact on the development of TREG cell–based therapies, the core technology behind PolTREG’s approach to treating autoimmune diseases
- the preclinical and clinical advancement of PolTREG’s programs, with clearly defined indications and a global market of unmet medical needs
- regulatory strategy (FDA), financing, grants, and partnering potential

PolTREG S.A. is an example of a Polish biotech company where science, intellectual property, and business strategy are aligned and scalable.

If you are analyzing biotech/medtech companies and looking for projects with growth potential, this interview is well worth watching.

Interview link (in Polish):

Tegoroczna Nagroda Nobla w dziedzinie medycyny została przyznana za odkrycia dotyczące komórek regulatorowych Treg, które PolTREG wykorzystuje w rozwijaniu t...

04/12/2025

Dear Investors, we invite you to an online meeting with the Management Board of PolTREG to discuss the Company’s current operational activities and development outlook for the coming quarters.

Participants:
Prof. Piotr Trzonkowski – President of the Management Board, CEO
Mariusz Jablonski – Member of the Management Board

Date: December, 10 2025 (Wednesday)
Time: 12:00 PM

Registration link: https://ccgroup.clickmeeting.com/poltreg-s-a-3q-2025/register
Registration is required – you will receive an email with your individual access link.
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Zapraszamy na spotkanie online z Zarządem PolTREG poświęcone omówieniu bieżących działań operacyjnych oraz perspektyw rozwoju w kolejnych kwartałach.

w spotkaniu udział wezmą:
Prof. Piotr Trzonkowski - Prezes Zarządu, CEO
Mariusz Jabłoński - Członek Zarządu

data: 10 grudnia 2025 (środa)
godzina: 12:00

Link rejestracyjny: https://ccgroup.clickmeeting.com/poltreg-s-a-3q-2025/register
Wymagana jest rejestracja na spotkanie - otrzymacie Państwo e-mail z indywidualnym linkiem dostępowym.

27/11/2025

We’re so thrilled to announce the publication of our clinical data analysis confirming long-term safety and efficacy of PolTREG S.A.’s autologous Treg-based therapy for type 1 diabetes!

The study clearly documented that our therapy delays onset of T1D symptoms and works even 12 years after receiving the therapy. This is the longest follow-up of Treg-treated T1D patients ever published and a major step for the field. It shows that a well-crafted Treg product can deliver durable immune balance and help preserve beta-cell function long after treatment.

We enrolled 51 participants who took part in our clinical trials as children, so are now young adults who are 7.5 to 12 years after the administration of Tregs or standard of care therapy.

The results speak clearly:
- No severe adverse events, no tumors, no treatment-related safety issues - even a decade later.
- Sustained clinical benefit: higher C-peptide, longer remission and insulin-independence compared to standard care.
- The Tregs + anti-CD20 regimen delivered the strongest outcomes.

A big thank you to the patients, clinical teams, and everyone at PolTREG S.A. driving this work forward. The future of Treg therapy in T1D looks promising and we’re pushing it even further.

The study, conducted by the Gdański Uniwersytet Medyczny (Medical University of Gdańsk) and PolTREG S.A., followed patients 7.5–12 years after receiving autologous Tregs as children.

Full article (open access) in Diabetes, Obesity and Metabolism is available here: https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.70330

14/11/2025

World Diabetes Day - 14 November - marks the birthday of Sir Frederick Banting – one of the founding fathers of insulin. 100 years after the lifesaving discovery of insulin we are ready for another scientific revolution.

At PolTREG S.A. we strongly believe that diabetes will one day become a preventable disease. Our goal is to intervene before autoimmune destruction of insulin-producing cells progresses, offering patients a chance to remain symptom-free — and clinically healthy — despite their high genetic risk.

We develop treatment focused on Type 1 diabetes prevention. Our novel Treg cell therapy , PTG-007, resulted in clinical remission for up to 12 years in patients diagnosed with type-1 diabetes (T1D). PolTREG has the potential to develop and register the first therapy in the world that prevents the onset of clinical symptoms of type 1 diabetes.

We just started clinical trials with 150 patients as young as 3 years old who are at high risk of developing type 1 diabetes due to genetic predisposition, but have not yet shown any symptoms.

“In the past, T1 Diabetes was diagnosed only after symptoms onset. Today, thanks to antibody detection tests, we can detect the autoimmune process leading to disease development long before the symptoms onset. Additionally, our TREG therapy is optimal for young children. The treatment is based on the patient's own cells, minimising the risk of side effects typical of traditional immunosuppressive therapies." says Prof. Piotr Trzonkowski, CEO and co-founder of PolTREG S.A. „Our project portfolio also includes next-generation drugs in the form of allogeneic-modified Tregs and in-vivo immunomodulation. These earlier-stage projects naturally complement the life cycle management of our product portfolio, enhancing our commitment to innovative and transformative therapies", he adds.

07/11/2025

We are proud to welcome Dr. Adrian Bot, a renowned biopharmaceutical founder and scientist, who joins Immuthera’s Board of Directors and will also serve as Scientific Advisor to PolTREG S.A.

Dr. Adrian Bot has joined Immuthera to support the company with his unique experience in the commercialization of groundbreaking cell therapies.

Immuthera — PolTREG’s wholly owned U.S. subsidiary — is advancing breakthrough T regulatory (Treg) cell-based therapies to transform the treatment of autoimmune diseases.

“PolTREG is a global leader in the development of T-regulatory cell products with over 12 years of clinical experience in more than 100 patients. This data set in autoimmune disease patients is a unique strength in our rapidly evolving field of cell therapies. I am very excited to help Immuthera and PolTREG advance and commercialize transformative therapies based on engineered Tregs, for patients in need. We are traversing an inflexion point for the field, and I have high confidence in the leadership team under Dr. Piotr Trzonkowski as they are well positioned for a U.S. expansion.”— comments Dr. Adrian Bot.

Dr. Bot brings 27 years of experience in the U.S. biopharmaceutical industry:
• Founding CSO and EVP of R&D at Capstan Therapeutics, where he helped secure $165M in financing before its $2.1B acquisition by AbbVie (2025).
• Leadership roles at Kite Pharma, where he contributed to the success of Yescarta® and Tecartus®, landmark CAR-T cell therapies, prior to the company’s $11.9B acquisition by Gilead (2017).

" Dr. Bot is a seasoned, accomplished, and well respected leader in the evolving field of cell and gene therapies. He has demonstrated on two separate occasions, the ability to lead innovations in Cell therapy from R&D, to clinical translation, to acquisition, in the fields of ex vivo-engineered CAR-T and In-Vivo CAR-T. We share the vision that T regulatory cells, reinforced by the recent Nobel Prize awarded for their discovery, represent the next frontier in cell therapies for patients with autoimmunity and other disease indications. Dr. Bot’s experience and innovative scientific and business approach will be invaluable on our journey to ultimately commercialize Tregulatory cell therapies. We look forward to Dr. Bot’s input and guidance as we bring our therapies into the US and continue to develop next-generation Treg and Treg-based therapies," says Prof. Piotr Trzonkowski, founder and CEO of Poltreg S.A.

PolTREG continues to expand its U.S. presence through Immuthera, its collaboration with Kinexum Services LLC on FDA strategy, and an exclusive partnership with Antion Biosciences to develop multi-edited, allogeneic CAR-Treg therapies.

20/10/2025

We are excited to highlight the open lecture by Prof. Piotr Trzonkowski, CEO of PolTREG.

“Regulatory T Lymphocytes – From the Lab to Therapy”

This lecture will take place at 12:10 PM during the Plenary Meeting of the Committee of Immunology and Etiology of Human Infections, Polish Academy of Sciences, on October 30, 2025, at Staszic Palace, Warsaw, and online via Teams.

👉 Join the meeting here: https://teams.microsoft.com/dl/launcher/launcher.html?url=%2F_%23%2Fl%2Fmeetup-join%2F19%3Ameeting_ZDE2ZTNjMzctMjcwNC00ZGRmLWE0ZDEtODQzODBhNjk4MTI3%40thread.v2%2F0%3Fcontext%3D%257b%2522Tid%2522%253a%25223d21b0a7-5346-4822-b165-b670b422e4f7%2522%252c%2522Oid%2522%253a%25225f6037f0-772f-442c-a36a-84da2118b081%2522%257d%26anon%3Dtrue&type=meetup-join&deeplinkId=056c1688-0d15-4cfd-bd8e-04bd1ca3904c&directDl=true&msLaunch=true&enableMobilePage=true&suppressPrompt=true

🔑 Access code: Yt7NC7Gq

Join us in person or virtually to explore the latest advances in immunology and clinical translation.

13/10/2025

Zachęcamy do lektury 👇

12/09/2025

This Monday marks the start of the INNODIA EASD symposium in Vienna.

On September 15 at 18:10, Prof. Piotr Trzonkowski, CEO of PolTREG, will deliver a lecture titled: “T-regulatory cell-based products for preventing and reversing T1D.”

PolTREG is pioneering one of the most comprehensive platforms for Treg-based therapies, spanning polyclonal Treg, CAR-Treg, allogeneic Treg, antigen-specific Treg, and TCR-Treg – driving the future of immune regulation therapies.

Join us in Vienna to explore the science and innovation shaping tomorrow’s immunotherapies!

08/09/2025

We are pleased to announce that on September 26th in Tokyo, Prof. Piotr Trzonkowski, CEO of PolTREG, will take part in the Tregs as Medicine: Tolerance and InTolerance Symposium.

Prof. Trzonkowski will deliver a lecture titled:
“T Regulatory Cells: From Bench to Bedside.”

The symposium’s keynote speaker will be Distinguished Prof. Shimon Sakaguchi, M.D., Ph.D., Principal Investigator at Osaka University – the discoverer of regulatory T cells (Tregs).

See you in Tokyo!

03/09/2025

We’re pleased to announce that the Korean Intellectual Property Office has granted AZTherapies a new patent for the use of CAR-Treg therapy in autoimmune neurodegenerative diseases. PolTREG holds the exclusive global license for these innovative cellular therapies across all indications.

This CAR-Treg project is also protected by patents in Australia, the USA, and Japan.

PolTREG continues to advance one of the most comprehensive platforms for Treg-based therapies, including polyclonal Treg, CAR-Treg, allogeneic Treg, antigen-specific Treg, and TCR-Treg – driving the future of immune regulation therapies.

04/08/2025

First patient dosed in PolTREG’s Phase II trial for pre-symptomatic type 1 diabetes

We are pleased to announce that the first patient has received therapy as part of the Phase II PreTreg clinical trial targeting pre-symptomatic type 1 diabetes. The study will enroll 150 children aged 3–18 who, due to genetic predisposition, are at high risk of developing type 1 diabetes but have not yet shown any symptoms.

PolTREG has the potential to develop and register the first therapy in the world that prevents the onset of clinical symptoms of type 1 diabetes. This innovative approach has also been recognized by the U.S. FDA, which acknowledged the study as potentially registrational. It may allow for inclusion of Polish patients in statistical analyses of U.S.-based trials.

“Long-term study results in symptomatic type 1 diabetes confirm the efficacy and safety of the therapy developed by PolTREG. Globally, medicine is increasingly focused on interventions that begin before the first symptoms of disease appear — and our therapy fits seamlessly into this trend. By applying it at the earliest stage of disease development, we expect very promising outcomes — potentially even halting the disease before clinical symptoms emerge. If the trial confirms the therapy’s efficacy, we may be able to develop and register the world’s first drug that prevents the onset of type 1 diabetes symptoms. We believe this therapy has strong market and partnering potential.” - said Prof. Piotr Trzonkowski, CEO and Co-founder of PolTREG S.A.

The PreTreg trial is being conducted with support from the Polish Medical Research Agency, which awarded a grant (no 2022/ABM/05/00001 - 00) of PLN 31.7 million. Recruitment is already underway at university hospitals in Białystok, Gdańsk and Łódź, and will expand to six additional clinical centers across Poland.

Our goal is to intervene before autoimmune destruction of insulin-producing cells progresses, offering patients a chance to remain symptom-free — and clinically healthy — despite their high genetic risk.