Sanofi to acquire Provention Bio in $2.9B deal
Sanofi to acquire Provention Bio, adding to portfolio TZIELD, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D) for $25.00 per share in cash, representing an equity value of approximately $2.9 billion.
TZIELD (teplizumab) was approved in the U.S. last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
Provention Bio informs that in the future it is looking at testing TZIELD in combination therapy with cell therapies, which in our opinion confirms the great potential of the cell therapies under development by PolTREG in T1D. PolTREG cell therapy, like TZIELD, offers the possibility of a protective effect on insulin-producing pancreatic beta cells, thereby attenuating the autoimmune response, which in turn reduces the risk of symptomatic type 1 diabetes.
PolTREG at BIO International Convention Boston 2023
We are excited to announce that PolTREG will exhibit at Polish National Stand organized by Polish Investment and Trade Agency (PAIH) at the BIO International Convention Boston 2023, June 5-8.
See you soon!
Read more: https://www.bio.org/events/bio-international-convention/registration-information?utm_medium=paid-search&utm_source=google&utm_campaign=international-convention-2023-search&utm_term=bio%20events&gclid=Cj0KCQiAgaGgBhC8ARIsAAAyLfG3SegeLtpxGbXZkovYjRy-oL3yoqWN8C2MDxxiXGJ25cjngTN1PyQaAihdEALw_wcB
PolTREG awarded for contribution to the development of the Polish economy
We are pleased to announce that PolTREG was awarded for contribution to the development of the Polish economy.
The award was awarded at a ceremony organized by the Krakow Technology Park.
Source: Krakowski Park Technologiczny.
Award of the Minister of Education and Science for outstanding achievements in implementation of scientific discoveries into clinical practice
On February 19th 2023, during the First World Copernican Congress in Toruń, the Gala of Polish Science was held. During the Gala winners of the Awards of the Minister of Education and Science were announced. This year prof. Natalia Marek-Trzonkowska, member of the PolTREG Scientific Board and PhD student dr Karolina Piekarska (Laboratory of Clinical Immunology and Transplantology of the University Clinical Centre in Gdańsk) were awarded for outstanding achievements in implementation of scientific discoveries into clinical practice. Studies resulted in 2020 in two inventions related to regulatory T cell (Tregs) therapy submitted to the European Patent Office. These inventions enhance the therapeutic potential of Tregs expanded in vitro in the presence of mesenchymal stem cells. The methods were developed thanks to the cooperation of University of Gdańsk, Medical University of Gdańsk and PolTREG S.A. The inventions have been and implemented for the treatment of type 1 diabetes in children by PolTREG S.A.
The ceremony starts at 2:21:30
PolTREG signs an agreement with Clinmark for clinical trials in PreTREG project
– The expanding partnership with Clinmark is another important step for us bringing PolTREG closer to the start of a Phase I/II clinical trial of the PreTREG diabetes therapy project.We are already co-operating with several centers for the clinical trial – said Prof. Piotr Trzonkowski, CEO and co-founder of PolTREG.
Learn more here: https://stooq.pl/n/?f=1536390
Polish Press Agency: PolTREG might establish partnership with pharmaceutical company in 2023, selection of advisor soon
“We are in the process of preparing for the next stages of clinical trials. Although we have the production capacity to start them immediately, we prefer to use preparations manufactured at our new state-of-the-art plant currently being under the final stages of construction. This is critical because the European Medicines Agency (EMA) places a strong emphasis on the quality, safety and efficacy of any new cell and gene therapy products. We therefore believe that it is important for the successful future regulatory process and clinical trials, to have the preparation produced in a single large scale manufacturing facility,” – said Prof. Piotr Trzonkowski, CEO of PolTREG.
“Later this year, we plan to initiate discussions with pharmaceutical companies that may be responsible for distributing our therapy. Our goal is to reach agreement on the details of this process before starting the study” – said Mariusz Jablonski, a member of the management board at PolTREG.
Complete article: https://biznes.pap.pl/pl/news/pap/info/3380375,poltreg-moze-nawiazac-wspolprace-z-firma-farmaceutyczna-w–23–wybor-doradcy-wkrotce-(wywiad)
PolTREG at 5th Treg Summit in Boston!
We are pleased to announce that our CEO, Prof. Piotr Trzonkowski will participate at the 5th Treg Summit in Boston May 30 – June 1
Learn more here: https://poltreg.com/wp-content/uploads/2023/02/5th-Treg-Summit-Full-Event-Guide.pdf
PolTREG at EMA Info Day
Prof. Piotr Trzonkowski, CEO PolTREG greatly enjoyed participating in European Medicines Agency Info Day: Regulatory support for the development of innovative medicines and technologies
If you missed it, check the recording here:
PolTREG development plans in 2023
Webinar with the Management Board:
PolTREG signs an agreement with Medical Research Agency
PolTREG and the Medical Research Agency have entered into an agreement to implement and financially support a project entitled “Cell therapy for prediabetes based on artificially multiplied CD4+CD25+CD127 – regulatory lymphocytes and anti-CD20 antibody.”
The total cost of the project, which is eligible for funding, is PLN 49.5 million. The grant awarded for this purpose has a value of PLN 31.7 million. The project implementation period shall conclude on 24 November 2028.
The objective of this agreement is to conduct industrial research and development with the aim of conducting clinical trials and, ultimately, implementing an innovative cell therapy for patients in the prediabetes phase of type 1 diabetes. The planned research tasks include the preparation and execution of a Phase II clinical trial.
Dr Mateusz Gliwinski laureate of the Prime Minister’s Award for an outstanding doctoral dissertation
Dr Mateusz Gliwinski, an employee of PolTREG S.A., was awarded the Prime Minister’s Award for Outstanding Doctoral Dissertation: “Antigen-specific regulation of the immune system in type 1 diabetes” carried out under the LEADER program, STRATEGMED NCBiR and the R&D program of PolTREG S.A. The dissertation promoters were dr Dorota Iwaszkiewicz-Grześ and prof. Piotr Trzonkowski.
International consortium project with PolTREG S.A. recommended to receive €7 million grant from Horizon Europe
PolTREG S.A., a world leader in cell therapies based on T-regulator cells (TREGS), has received information about the recommendation for funding under the Horizon Europe program by the European Executive Agency for Health and Digitization of the project entitled “Autoantigen-specific adoptive regulatory T cell therapy against type 1 diabetes (ARTiDe),” in which the Company is a member of the consortium. The consortium includes internationally renowned French and German universities and biotechnology companies. The value of financing for the consortium is about EUR 7 million, while the subsidy attributable to PolTREG S.A. is about EUR 0.8 million. The financing constitutes 100% of the project expenses.
PolTREG S.A recommended to receive PLN 31.7 million grant from the Medical Research Agency to conduct Phase II clinical trials in cell therapy for prediabetes conditions
PolTREG S.A. received information on November 21, 2022 that the company’s project entitled “Cell therapy of prediabetes based on artificially multiplied CD4+CD25+CD127- regulatory lymphocytes and antiCD20 antibody” has been qualified for funding from the Medical Research Agency. The total cost of the project is PLN 49.5 million. The grant awarded to the company is PLN 31.7 million, while the project’s implementation period is scheduled for 2022-2028. The condition for the transfer of funds is the signing of a grant agreement. The aim of the project is to conduct Phase II clinical trials.
PolTREG has choosen a CRO for the first in a series of planned clinical trials
On October 24th the company has signed a framework agreement with Clinmark, an international CRO, defining the principles of comprehensive cooperation in the execution of clinical trials.
Additionaly with the framework agreement, the companies have entered into an order to conduct a phase 1/2 clinical trial in primary progressive multiple sclerosis (PPMS).
PolTREG is moving significantly closer to the start of a series of planned clinical trials using TREGs innovative cell therapy.
Save the date: January 31, 2023 EIC – EMA Info Day: Regulatory support for the development of innovative medicines and technologies
We are excited to announce that prof. Piotr Trzonkowski, CEO of PolTREG S.A. will be speaking at EIC – EMA Info Day conference as the only representative of the Polish biotech industry. Event is co-hosted by the European Innovation Council (EIC) and the European Medicine Agency (EMA).
Prof. Piotr Trzonkowski will give a presentation entitled: „The parallel journeys from Academia to Enterprise & from ITF to Scientific Advice – Q&A” sharing his experience collected in cooperation between PolTREG and EMA including Agency’s services such as ITF support, EMA’s advanced therapies classification and certification, and scientific advice.
Learn more here https://eic.ec.europa.eu/events/eic-ema-info-day-regulatory-support-development-innovative-medicines-and-technologies-january-31-2023-01-31_en
The Info Day will provide an overview of the range of support that innovators in the pharmaceutical sector can access at the European Medicines Agency (EMA) to optimise their development programmes.
Scientists from Poltreg S.A. report first successful manufacturing of CARTREGS for the treatment of neuroimmune conditions.
The time lapse movie (originally 13-hours-lating) shows in vitro model of the therapy with CARTREGS manufactured in Poltreg’s laboratory. The big cell in the middle express cloned glia antigens. It is actively recognised by the manufactured CARTREGS (small green cells) expressing CAR receptors towards the antigens. The CARTREGS attach to the surface of glia cell and actively protect it against autoimmune attack.
Poltreg S.A. develops CARTREG cell therapy product in the cooperation with AZTherapies from Boston, USA. The therapy with the cells will be tried in clinical trials in neuroimmune conditions such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). CARTREGS are engineered T regulatory cells expressing chimeric receptor cloned into the cells. Poltreg’s product contains receptors against glia. This design allows CARTREGS for the recognition of glia of the brain and spinal cord, where they generate functional barrier and protect the central nervous system against autoimmune attack. This way the disease can be alleviated or even stopped.
More details about the technology will be presented at the conference ‘Therapeutic Tolerance Lessons Learned’ organized by the University Newcastle in Newcastle upon Tyne, UK, 28th June -1st July 2022 (https://www.therapeutictolerance.com/home)
Movie by Magdalena Piotrowska, Mateusz Gliwiński, Aurelia Schweda and Dorota Iwaszkiewicz-Grześ.
The Paediatric Committee of the European Medicine Agency issued a positive opinion and accepted the clinical development plan of the PolTREG company as part of the treatment of type 1 diabetes in children
- Approval of the Paediatric Investigation Plan (PIP) by the Paediatric Committee (PDCO) of the European Medicine Agency (EMA) is required for the EU Marketing Authorization procedure for new medicines
- Successful completion of the paediatric investigation plan procedure may make the way for achieving additional market exclusivity for the therapy used
- A positive PDCO opinion is a significant regulatory milestone for the Company in the development and marketing approval of treatment of type 1 diabetes in children
“This is another important that brings us step closer to the initiation of key stages of clinical trials. We intend to continue our close cooperation with regulatory authorities to bring our treatment to the European market as soon as possible. A positive assessment of our trial plan means that the presented results within the Company’s R&D work are satisfactory for the EMA and the plan of further clinical trials in the treatment of type 1 diabetes in children is appropriate and its implementation in case of positive results will lead to approval of the therapy under a centralised procedure in the European Union. I would also like to note that in the fourth quarter of this year, we have a pre-IND meeting with the US FDA planned, where we will also consult a paediatric plan.”, said Prof. dr hab. n. med. Piotr Trzonkowski, President of the Management Board, co-founder and shareholder of PolTREG S.A.
PolTREG received response regarding the production of regulatory T lymphocytes for the treatment of type 1 diabetes from the European Medicines Agency (EMA) within the framework of the scientific advice procedure
PolTREG S.A., an innovative biotechnological company developing therapies using T-regulator cells (TREGS) in the treatment of type 1 diabetes and multiple sclerosis, achieved another significant step closer to the Company’s initiation of key stages of clinical trials.
The Company received a positive response (within the framework of the scientific advice procedure) from the European Medicine Agency on 20 May 2022 concerning the method of manufacture of T-cell preparation for the treatment of patients diagnosed with type 1 diabetes, adopted by the Company.
“We are very pleased that the EMA has confirmed our approach to the way we manufacture our preparation, accepting the methods we use to manufacture and control quality. The EMA has also provided additional scientific guidance on the necessary research and development of the product in the context of the planned clinical trials (type 1 diabetes) with the product and applying for a marketing authorisation in the European Union. Positive responses from EMA allow us to initiate planned clinical trials in type 1 diabetes and multiple sclerosis. They are designed as multicentre clinical trials involving leading clinical sites. The responses received from EMA within the framework of scientific advice confirm the design of the studies adopted by us and the approach to manufacturing products for these trials, and thus constitute a significant factor in managing the risk of non-registration and failure to market the medicine,” said Mariusz Jabłoński, Member of the Management Board of PolTREG S.A.
The clinical trials currently planned by PolTREG will be of multi-center nature. The Company plans to establish competence in the centres with which it cooperates to provide full service to the patient as part of the proposed treatment. For patients during the trials, but also after the product has been registered, this will mean full service in the place where they are treated without the need to travel to the company’s registered office in Gdańsk. Patient will go to their doctor, will have all tests and blood collection done at the site, and once produced, Tregs will be brought back to the treatment where the patient will be administered with it. This means much higher comfort for patients and their physicians. This is also important for the company because its therapy will reach a larger group of patients. This applies both to clinical trials currently in place and the routine offering of this therapy in the future following marketing authorization in the European Union.
The Patent Office of the Republic of Poland granted patent to Gdańsk Medical University (GUM) for the invention entitled “Administration of Tregulatory lymphocytes as a drug in the treatment of multiple sclerosis.”
Under an exclusive license (on the basis of a license agreement concluded with the GUM of June 2015), PolTREG uses the TREG method covered by patents granted to GUM and patent applications made by GUM.
The Foundation for Polish Science has recognised the publication of PolTREG scientists as one of the 30 most important achievements of research in Polish scientists in global science in the last 30 years.
Publication on regulatory T cell therapy by scientists from PolTREG: By Piotr Trzonkowski, Maria Bieniaszewska, Jolanta Juścińska, Anita Dobyszuk, Adam Krzystyniak, Natalia Marek, Jolanty Myśliwska, and Andrzej Hellmann “First-in-man clinical results of the treatment of patients with graft versus host disease with human ex vivo expanded CD4+CD25+CD127-T regulatory cells”. Clin Immunol. 2009 Oct;133(1):22-6 has been recognised by the Foundation for Polish Science as one of the most important 30 research achievements made by Polish scientists in the past 30 years.
All 30 achievements have been described in the book “Sięgając po niezbadane”, which was prepared on the occasion of 30th anniversary of the Foundation for Polish Science. The preliminary presentation of the publication took place on Tuesday, April 12 in Warsaw. The book contains texts on research in the field of, among others, physics, biotechnology, immunology, astrology, chemistry, mathematics, environmental protection, oncology, psychology, demographics, archeology and history. All the described findings were conducted by scientists affiliated by Polish scientific institutions.
LINK to electronic version of the book: Patrycja Dołowy, Karolina Głowacka, Anna Mateja “Sięgając po niezbadane”: https://www.fnp.org.pl/assets/Siegajac_srodek.pdf
Start-ups in biotech industry. How to do this in Poland? An online meeting with Prof. Piotr Trzonkowski at the Leon Koźmiński University
If you want to learn how to successfully develop a biotechnology company from an idea to obtaining financing and entering the Stock Exchange.
We invite you to attend an online meeting on March 24, at 6.00 p.m. with Prof. Piotr Trzonkowski within the “A-grade Health Care Management” cycle, organized by the Leon Koźmiński University.
Link to event: here
Prof. Piotr Trzonkowski was the guest for the broadcast entitled “Wieczór odkrywców” (Evening of Discoverers) of the Program I of Polskie Radio
One of the most important scientific achievements of Polish researchers in recent years is the result of research on regulatory T cells, or Tregs, and their pioneering use in the cell therapy of hazardous autoimmune diseases, including type 1 diabetes. By administering regulatory cells, we are able to delay its development, said Prof. Piotr Trzonkowski in Program 1 of Polskie Radio.
The broadcast recording is available for listening on the website: https://www.polskieradio.pl/7/5098/Artykul/2903115
PolTREG scientists published an article on interactions between mesenchymal cells with TREGS cells in Nature Communications
On 14 February 2022, an article was published in the prestigious Nature Communications journal entitled “Mesenchymal stem cells transfer mitochondria to allogeneic Tregs in an HLA-dependent manner improving their andmmunosuppressive activity”.
The authors of the study include researchers from the PolTREG S.A. in cooperation with the University of Gdańsk and the Medical University of Gdańsk.
The work involves interactions of mesenchymal cells with TREGS cells. Scientists described the phenomenon of mesenchymal cells “lending” mitochondria to TREGS lymphocytes, which significantly increases the activity of the latter and may be used in therapy. The use of the phenomenon is also the subject of patent applications, of which PolTREG S.A. is a co-owner.
Link to the article (available free of charge): https://www.nature.com/articles/s41467-022-28338-0
PolTREG will receive from PLN 9.3 million funding from NCRD for the development of TREGS therapy in multiple sclerosis
PolTREG S.A. has concluded an agreement on project co-financing with the National Centre for Research and Development (NCRD): “Safe cellular therapy for multiple sclerosis based on artificially proliferated CD4+CD25+CD127- regulatory lymphocytes”.
The NCRD grant of PLN 9.3 million will be allocated to co-financing a clinical trial in multiple sclerosis. The aim of the study is to confirm the efficacy, safety and optimal dosing of innovative immunosuppressive/immunomodulating therapy of multiple sclerosis (relapsive-remitting RRMS and primary progressive – PPMS) with isolated and artificially multiplied T cells (TREGS). The total cost of the project is PLN 15.6 million.
Brokerage House of Bank Ochrony Środowiska recommends “buy” for PolTREG
The report was released on December 12, 2021. The BOŚ Brokerage House analysts started to issue a “buy” recommendation for PolTREG from with a target price of PLN 133.1.
Ipopema Securities recommends “buy” PolTREG
Ipopema Securities analysts, in a report dated December 6, 2021, started to issue recommendation “buy” for biotechnological company PolTREG S.A., evaluating one share of the company at PLN 155.
“We estimate PolTREG using the rNPV method, from which we have received a price at PLN 155 per share. The Treg 2.0 project and cooperation with AZTherapies (the cooperation agreement already signed after the IPO) have the potential to increase our pricing, since the forecasts take into account some costs associated with these projects, but we do not take into account their commercialisation”, analysts wrote in the report.
Invitation to submit an offer in the proceedings to select the audit company to perform the financial inspection of financial statements of PolTREG S.A. with its registered office in Gdańsk for the years 2021-2022
The object of inquiry is the audit firm to conduct financial revision activities including:
- inspection of the Company’s financial statement for the period from 1 January 2021 to December 31, 2021, prepared in accordance with the International Financial Reporting Standards (along with the assessment of the remuneration report based on KSUA 3000, in accordance with Art. 90g. 10 of the Act on public offer and submission of the Attestation Report);
- inspection of the Company’s interim condensed financial statement for the period from 1 January 2022 to 30 June 2022, prepared in accordance with International Financial Reporting Standards;
- inspection of the Company’s financial statement for the period from 1 January 2022 to December 31, 2022, prepared in accordance with the International Financial Reporting Standards (along with the assessment of the remuneration report based on KSUA 3000, in accordance with Art. 90g. 10 of the Act on public offering and submission of the Attestation Report).
Offers should be submitted by e-mail by December 15, 2021 to the following address: email@example.com
Prof. Piotr Trzonkowski – co-founder and President of the Management Board of PolTREG S.A. is laureate of the first edition of the “Leaders of the Future” Plebiscite
The “Forbes” magazine jontly with Range Rover, distinguished the visionaries and leaders of the future. Of the 140 nominated candidates, the Plebiscite’s Chapter slected 10 leaders from various domains of life, who are experts in their fields and the visionaries that create the future.
Prof. Trzonkowski has been recognized for the development of T-cells (TREGS) therapy in the treatment of autoimmune diseases, especially type 1 diabetes and multiple sclerosis.
– TREGs supervise the action of the immune system in the human body. Their numbers in the organisms of children with type 1 diabetes are too low. Our team has been first in the world to have developed an effective method of their multiplication”, said Prof. Trzonkowski to Forbes.
Link to the article in Forbes about the “Leaders of the Future” Plebiscite Laureates: https://www.forbes.pl/przywodztwo/oto-laureaci-pierwszej-edycji-plebiscytu-leaders-of-the-future/hxy1ycp
PolTREG S.A. debuts at the Warsaw Stock Exchange
At 9 a.m., on 23 November PolTREG will debut on the Warsaw Stock Exchange. The ceremony of PolTREG’s debut will be streamed: https://www.youtube.com/watch?v=3ZOAnlE9UWw
PolTREG S.A. signed an agreement with the U.S. AZTherapies Inc. with Boston (AZT) on the development and commercialization of therapies based on CAR-Treg cells for the treatment of autoimmune neurological diseases.
- Thanks to cooperation with AZTherapies, PolTREG will expand the pipeline of projects, accelerate the development of technology and has the chance to be the global leader in the dynamically developing CAR-Treg segment highly valued by the market.
- AZT grants PolTREG an exclusive license to commercialize CAR-Treg therapy in therapeutic and prophylactic use throughout the world and licenses to develop, manufacture and use CAR-Treg therapy for clinical trials.
- PolTREG plans to initiate a clinical trial of 1/2 CAR-Treg therapy in the first half of 2023 in the treatment of one of neurological autoimmune diseases (e.g. amytrophic lateral sclerosis). The completion of the phase 1/2 trial in the CAR-Treg treatment area is planned for 2025. The potential of the CAR-Treg therapy market in the treatment of ALS is ~ USD 12 billion.
The Puls Biznesu podcast entitled “Business ways for diabetes” hosted Prof. Piotr Trzonkowski
Prof. Piotr Trzonkowski, co-creator and President of the Management Board of PolTREG S.A., talked with ed. Marcel Zatoński from Puls Biznesu about the epidemic of diabetes in children and the hope to stop it. The podcast is available on the Puls Biznesu website: https://www.pb.pl/finansowanie-walki-z-cukrzyca-1133131
PolTREG assigned shareholders series M shares. Subscriptions in the Individual Investors Tranche were reduced by over 24%
On November 8, 2021, the Management Board of PolTREG S.A. gave an allocation of 1,332,414 new series M shares offered in the Public Offer.
As part of the Offer, the maximum number of New Shares was assigned, with:
- 1.486 Individual Investors received 266.482 New Shares, with an average reduction rate of 24.218% for Individual Investors.
- 26 Institutional Investors received 1,065,932 New Shares. The number of New Shares offered to the Institutional Investors was equal to the number of New Shares to which the Institution Investors subscribed, no reduction of the subscriptions were made.
PolTREG becomes member of the BioInMed Polish Association of Innovative Medical Biotechnology Companies
The BioInMed Polish Association of Innovative Medical Biotechnology Companies was established by 11 companies, i.e. Ardigen SA, Captor Therapeutics SA, Celon Pharma SA, ExploRNA Therapeutics SA, OncoArendi Therapeutics SA, Polski Bank Komórek Macierzystych SA, PolTREG SA, Pure Biologics SA, Ryvu Therapeutics SA, Selvita SA and WPD Pharmaceuticals Sp. z o.o.
The Association was created in order to, in collaboration with all stakeholders and public administration, build the infrastructure that enables medical biotechnology to become the showcase of Polish innovation and may also be a driving force for the economy in the future.
Autumn 2021 – we shall be present
In autumn 2021 Poltreg will present the results of clinical trials in several important scientific meetings:
- October 25-26 – 3 Health of Poles Congress
- November 8-10 – VIII 8th EUROBIOTECH Congress, Kraków
- November 25-26 – XV Congrés de la Societat Catalana d’Immunologia, Barcelona (online)
web: http://www.sci.cat; https://www.academia.cat/files/425-19089-DOCUMENT/PostercongrsSCI2021.pdf
September 2021 – VI Europejski Kongres Immunologii
On 01 – 04 September 2021 prof. Piotr Trzonkowski took part in the VI European Congress of Immunology – Belgrade / Istanbul (online event). The professor made a presentation „From bench to bedside – Clinical therapy with T regulatory cells”.
September 2021 – Patent granted by USPTO
In September, the United States Patent and Technology Office announced that on July 27th 2021, the founders of PolTREG S.A. were granted of the patent entitled “In vitro method of expansion of CD4 + FoxP3 + regulatory T cells” (US Patent No. 11,072,779). The company has an exclusive patent license.
Photo shows prof. Natalia Marek-Trzonkowska with the patent.
July 2021 – PolTREG S.A. submitted the Prospectus to the Polish Financial Supervision Authority
PolTREG S.A. is currently at various stages of clinical research and development (therapy of type 1 diabetes in children, and multiple sclerosis) using T-regulatory cells (TREGS). The company’s strategy assumes the development of a platform for therapies based on the use of TREGS in the treatment of autoimmune diseases and achieving the position of one of the leaders of such therapies in the world.
The Company submitted at the end of June, to the Polish Financial Supervision Commission (in PL: KNF) prospectus in connection with the intention to carry out an initial public offering (IPO), and admission and introduction of shares to trading on the regulated market of the Warsaw Stock Exchange in Warsaw S.A. (in PL: GPW).
PolTREG plans to debut on the stock exchange in the fourth quarter of 2021. The funds that the Company intends to obtain from the public offering (IPO) shall be used to finance the current research and development projects related to the next stages of clinical trials on the treatment of type 1 diabetes in children and the treatment of multiple sclerosis.
Doctor Mateusz Gliwiński is awarded with GOLDEN OTIS 2021 in the scientific debut category for his PhD work in which the dominant role of proinsulin in the development of type 1 diabetes has been proved. Doctor Gliwiński described also the idea of new cellular therapy based on this antigen in type 1 diabetes. Doctor Dorota Iwaszkiewicz-Grześ and Prof. Piotr Trzonkowski were the tutors. The work was supported by the grants from National Centre for Research and Development: LIDER/160/L-6/14/NCBR/2015, STRATEGMED1/233368/1/NCBR/2014 to Medical Univ. Gdańsk and POIR.01.01.01-00-0769/15-03 to Poltreg SA. The award ceremony will take place in April 2021.
The Trust Awards ZŁOTY OTIS have been given annually for exceptional achievements in medicine by Świat Lekarza journal. The awardees are chosen by the chapter of eminent scientists, medics, members of patients’ organizations and pharmaceutical industry. See more: https://zlotyotis.pl/
Prestigeous journal Biodrugs published report from our phase 1 study testing T regulatory cells in multiple sclerosis:
Kamil Chwojnicki, Dorota Iwaszkiewicz-Grześ, Anna Jankowska, Maciej Zieliński, Paweł Łowiec, Mateusz Gliwiński, Małgorzata Grzywińska, Kamil Kowalczyk, Aleksandra Konarzewska, Paulina Glasner, Justyna Sakowska, Julia Kulczycka, Anna Jaźwińska-Curyłło, Marlena Kubach, Bartosz Karaszewski, Walenty Nyka, Edyta Szurowska, Piotr Trzonkowski. Administration of CD4 + CD25 high CD127 – FoxP3 + Regulatory T Cells for Relapsing-Remitting Multiple Sclerosis: A Phase 1 Study. BioDrugs 2021 Jan;35(1):47-60. doi: 10.1007/s40259-020-00462-7.
Czech Liaison Office for Research, Development and Innovation (CZELO) distinguished our project as the example of good practice realized with the support from Horizon 2020 by the company from Visegrad countries (see page 58 of the brochure)
The Ministry of Regional Development just released results of the competition 2.1 PO IR (Support for R@D center). Poltreg S.A. has been scored the highest 28 points and received grant = 10 597 978,30 PLN (≈2.4mln Euro) for the infrastructure.
Poltreg S.A. among 5 Top Healthcare Startups Tackling Type 1 Diabetes. Portal startus-insights analyzed 72 healthcare startups tackling Type 1 Diabetes (T1D). Our company was scored among Top 5 developing medical solutions to watch out for.
Scientists from the Medical University of Gdańsk, Poltreg S.A. and Technische Universität Dresden published the description of new generation of medicinal product containing antigen-specific T regulatory cells. The work: „Antigen-reactive regulatory T cells can be expanded in vitro with monocytes and anti-CD28 and anti-CD154 antibodies” can be read in the Cytotherapy – official journal of the International Society of Cell and Gene Therapy. The product is intended for the treatment of autoimmune diseases. The paper summarizes the research and patent claimed under the same title last year.
During 80th Scientific Sessions of the American Diabetes Association (12-16.06.2020) the scientists from STRATEGMED TREGS consortium and PolTREG company presented for the first time presumptive results of the phase II trial with T regulatory cells. From the tested approaches, the combined treatment with T regulatory cells and antiCD20 antibody proved to be the most promising. The patients treated with this combined scheme were in the clinical remission almost throughout entire 2-year-lasting follow-up, being administered with less than 0.5 units of insulin per kg body weight daily. At the same time, they were characterized by the best metabolic control with glycosylated haemoglobin HbA1c below 6.5%. The patients treated with this combined regimen achieved the longest insulin-independence which lasted as long as 18 months post-treatment.
Why does insulin trigger diabetes and what is the role of T regulatory cells?
Poltreg S.A. took a part in the resrearch just published in BMJ Open Diabetes Research and & Care. The work is a collaborative study of the medical universities from Gdańsk, Łódź, Katowice, University of Gdańsk, Regional Blood Bank and Poltreg S.A. in which the scientists proved that insulin is not only the hormone but also a dominant autoantigen involved in the development of type 1 diabetes
The links between insulin and the development of type 1 diabetes are known but the current work explains how insulin antigens trigger the progression of disease. Namely, the fragments of proinsulin sensitize and activate the immune system, which starts pathologic response against pancreatic islets secreting the hormone.
Why does not everybody develop the diabetes? It is because antigen-specific T regulatory cells, which are able to stop the activation of the immune system in the majority of people. The number of these cells is extremely low (below 0,01% in the peripheral blood) and only the recent laboratory tools used in the presented work were able to detect them.
The results of the work allowed the scientists from Poltreg S.A. and Medical University of Gdańsk to create the next generation of cellular drug which will be able to stop the activity of the immune system against insulin fragments and pancreatic islets.
Full text of the paper is available at: http://drc.bmj.com/cgi/content/full/8/1/e000873
The work was supported by the grants LIDER/160/L-6/14/NCBR/2015, STRATEGMED1/233368/1/NCBR/2014 and POIR.01.01.01-00-0769/15-03 from National Centre for Research and Development.
Final report from the study on safety of Tregs in multiple sclerosis
Medical University of Gdańsk together with Poltreg’s scientists submitted final report from the study: „Cell therapy of multiple sclerosis with ex vivo expanded CD4+CD25+CD127- T regulatory cells” to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The results wil be published soon in the specialist journal.
Poltreg S.A. attended the meeting ‘Business in the Genes’ at the Warsaw Stock Exchange. We presented the progress of the company and reported accomplishment of phase II study in type 1 diabetes and phase I in multiple sclerosis. We also showed our current preparatory work on pivotal phase III study in type 1 diabetes in Eurpe and USA. We have also informed about hospital exemption procedure, which allows us to offer the therapy in the University Hospital in Gdańsk. The first patients were administered with the preparation already. Finally, we discussed current financial needs of the company and the progress of the fundraising to date.
Prof. Trzonkowski presented the lecture ‘Treatment of autoimmune diseases with T regulatory cells in humans – promises and hurdles’ during the workshop ‘Discovery to clinical applications of regulatory T cells in autoimmunity and transplantation’ organized by the British Society of Immunology.
The patient’s trust award ‘Złoty Otis’ for her achievements in endocrinology and diabetology to Prof. Myśliwiec
Prof. Myśliwiec elected again to be the member of the Board of the Polish Society of Diabetology for the term 2019-2023.
The Award of the Polish Society of Diabetology to Prof. Myśliwiec for Her spectacular achievements in the clinical and experimental science in diabetology. The ceremony took place during the the XX Congress of the Polish Society of Diabetology in Lublin, in which prof. Myśliwiec gave the inaugural Jakub Węgierka’s lecture: ‘Running for success in diabetology’.
Scientists from Poltreg presented their academic and commercial experience with the Tregs at the TREG SUMMIT in Boston.
Poltreg presented its current strategy at LSX World Congress in London. The Congress is a high-calibre, senior executive, conference, exhibition and partnering event providing the education, strategies, solutions and contacts that life science executives need to enable more effective investment, planning and strategic growth within their businesses.
Prof. Piotr Trzonkowski gave a lecture on TREG method during European Congress of Immunology in Amsterdam. The congress is the biggest and the most important European event on immunology taking place every three years in different European cities.
PolTREG has been awarded 2 500 000 Euro grant in Horizon2020 in the healthcare biotechnology sector.(project 830559 – TREG: TREG – innovative cell therapy targeting Diabetes Type 1). We are the only Polish SME company that received support in this instrument in the area of healthcare. The money will be spent on the preparations to phase III clinical trial in type 1 diabetes.
Report on adverse effects from clinical trials on type 1 diabetes and multiple sclerosis confirmed good safety profile of the treatment.
Scientists from Poltreg are co-authors of the minimum information model on Treg cell therapy (MiTREG). The paper describing MiTREG brought together over 50 scientists from all over the world.
Last patient recruited into phase I trial on multiple sclerosis in STRATEGMED TREGS programme. Full results of the study will be available in second quarter of 2019.
Inventor of TREG method Prof. Piotr Trzonkowski has received the Foundation for Polish Science Prize 2017 in the life and earth sciences for studies on regulatory T cells and their pioneering use in cell therapy of human diseases. This is the most important scientific prize in Poland.
Last patient recruited into phase II trial on type 1 diabetes in STRATEGMED TREGS programme. Full results of the study will be available in third quarter of 2019.
Scientists from Poltreg took a part in the final meeting of the “Action to Focus and Accelerate Cell-based Tolerance-inducing Therapies (AFACTT). This is Europe’s Biggest Research Network on cell-based tolerance-inducing therapies that brings together around 100 scientists from 20 European universities.
Scientists from Poltreg published report with new data on laboratory technique increasing stability and quality of TREG preparation used in the treatment. The method is a subject of new patent application.
Scientists from Poltreg published report describing long-term effects of the therapy. The report proves that the patients treated with TREG cells could produce insulin more than 2 years after administration of the preparation.