PolTREG S.A.’s Post

PolTREG caused a stir in the international press last week with news that brought PTG-007 – which may one day prevent type-1 diabetes (T1D) – one step closer to the market. We announced an early look into the results of a long-term data study, with which we proved the safety and efficacy of the drug candidate in early-onset T1D. The Pharma Letter, BioCentury, Manufacturing Chemist and BioPharma reporter all covered the story. The study frees up the way for us to launch a pivotal study, the final step before we can request market authorization for PTG-007. Later this year, we will launch a new trial with PTG-007 in children with diabetes – but before they start showing symptoms. Read our press release here: https://lnkd.in/dNEyDRK7

Treg cells are a candidate therapy for type-1 diabetes (T1D) that has proven its efficacy in clinical trials, and is safe. That is the gist of a letter PolTREG published in Science Translational Medicine (STM) in May. It was a reaction to an article that described the lack of efficacy in a Phase 2 clinical trial by Caladrius, also in Treg cells in T1D. When diabetes is diagnosed, the body’s immune system has destroyed almost all the cells producing insulin. That means there is simply nothing left for the Treg cells to protect. But when PolTREG allowed earlier-stage patients into the trial, we saw  that patients treated with Tregs were able to still secrete insulin 2, 5 and in some cases, up to 8 years later. A second study showed improved insulin secretion in patients treated with both Tregs and Rituximab. In both studies, patients who did not receive Tregs completely lost the ability to secrete insulin. In our letter, we argue that this change in protocol might have fixed the poor efficacy of the Caladrius trial. And that is good news: it means that there is no reason to doubt the potential that Treg cells to become the first therapy to prevent T1D. PolTREG will be formally presenting long-term safety and efficacy data of its drug candidate PTG-007 in early-onset T1D at a conference in Europe in September. The data are a crucial step in bringing PTG-007 to market, and open up the way for a pivotal Phase 2/3 study. Later this year, PolTREG will launch a study in presymptomatic patients, hoping to prevent T1D before it starts showing any symptoms. This would free patients of the burden of having to take frequent insulin shots, and the serious long-term complications of the disease. To read our letter in STM, click here: https://lnkd.in/dw_fqQhR #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #type1diabetes

PolTREG will get access to new groups of type-1 diabetes patients with its Treg cellular therapies after signing a cooperation deal with the University Clinical Center (Uniwersyteckie Centrum Kliniczne w Gdansku), in Gdansk, Poland. PolTREG will produce its PTG-007 therapy with blood received from patients selected by the UCC, and deliver the finished product to UCC for a payment. Patients will then be injected with the preparation - derived from their own blood – at UCC. While PTG-007 is not yet on the market, it is available in Poland under a hospital exemption. It has shown a strong safety and efficacy profile in an earlier Phase 1/2 clinical study. PolTREG has the most advanced pipeline of Treg candidate therapies, which it produces in its own state-of-the-art manufacturing facility. It is the only company developing all available modalities of Treg therapies for a wide range of auto-immune diseases, including naturally occurring polyclonal T-cells and several types of next-generation engineered T-cells. PolTREG has 17 years of experience in treating patients with type-1 diabetes as well as multiple sclerosis, a period in which it has treated 100 patients. #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #type1diabetes

Another milestone for PolTREG. We are announcing positive results of a long-term safety and efficacy study of PTG-007 in early-onset type-1 diabetes (T1D). “At PolTREG, we believe that PTG-007 has the potential to prevent type-1 diabetes, freeing patients of the life-long burden of having to take frequent insulin injections, and the serious long-term complications of the disease. The results of this study are an important step in that direction,” said Prof Piotr Trzonkowski, PolTREG S.A. Chief Executive Officer.   Here are the main findings, found over a period of up to 12 years during which patients were monitored: ☑ Patients who received PTG-007 continued to secrete insulin, while untreated patients in the control group did not, ☑ Safety measures showed no significant difference in the health status of patients who received Treg therapy compared to the control group, ☑ The duration of disease remission was significantly longer in patients who received PTG-007 compared to the control group.   No other company currently can show similar long-term safety results of Treg therapy in T1D. This is a significant competitive advantage, and paves the way for the launch of a pivotal Phase 2/3 study of PTG-007 – a final step before seeking market authorization.   Read our press release here: https://lnkd.in/dNEyDRK7   #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #type1diabetes

Prof. Piotr Trzonkowski, Chief Executive Officer at PolTREG, and Mariusz Jablonski Chief Business Officer, highlighted why PolTREG S.A. is so different from other biotech firms developing cell and gene therapies, in an hour-long interview with Paweł Biedrzycki, editor-in-chief of Strefa Inwestorów (Investor Zone). Some of the main messages: ✅ PolTREG was the first company in the world to administer TREG therapies to patients, now 17 years ago. ✅ PolTREG is ready to start a pivotal clinical trial in type-1 diabetes (T1D) for its lead asset PTG-007, having sought advice from EMA. ✅ PolTREG has a state-of-the-art manufacturing facility, which allows it to manufacture cell therapies on a scale its competitors cannot. ✅ PolTREG has the most advanced pipeline of Treg candidate therapies. ✅ Only company developing all modalities of Treg therapies for auto-immune disease: from polyclonal T-cells to several types of engineered T-cells. Upcoming milestones include: 🔎 PolTREG expects to publish the results of a long-term safety study for PTG-007 in patients with early-onset type 1 diabetes (T1D). 🔎 The study will represent the only available clinical data over a 10-year period from the first administration of the therapy. 🔎 PolTREG is due to launch three new clinical trials for PTG-007: in presymptomatic T1D, and in two types of multiple sclerosis. Watch the full interview (in Polish!): https://lnkd.in/dR8nuUXM #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #type1diabetes

Green light for PolTREG to start producing next-generation T-reg cell therapies at its own pharmaceutical plant: the company just received approval to operate a genetic engineering facility from Poland’s ministry of Climate and Environment. We can now manufacture engineered T-reg cells at our state-of-the-art facility, including TCR-Tregs, CAR-Tregs and antigen-specific Tregs. These products offer exciting new ways to tackle the autoimmune diseases we are dedicated to help cure. PolTREG is developing every possible Treg therapy for a wide range of auto-immune diseases. It has more than 17 years of experience treating type-1 diabetes and multiple sclerosis patients with polyclonal cells. Over that period, it has administered Treg cells to more than 100 people, in clinical trials and through a hospital exemption. Our state-of-the-art manufacturing facility contains: ☑ 15 stand-alone production lines ☑ annual capacity of 1500 therapies ☑ 4000 sq. m of space #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #type1diabetes

The PolTREG team secured 52 meetings with investors, other biotech firms, technology providers and big pharma representatives at #BIO2024.   PolTREG has 17 years of experience administering Treg cell therapies to patients. Its cutting-edge science has enabled it to become the only company developing the full gamut of Treg cells, from polyclonals to several types of engineered cells.   In the four days of the conference – one of the largest in the biotech sector, with more than 20,000 participants – the team highlighted PolTREG’s Treg cell therapies to tackle type-1 diabetes, multiple sclerosis and a host of other autoimmune diseases.   The picture shows Chief Executive Officer Prof Piotr Trzonkowski, Chief Business Development Officer Dan Shelly PhD and Chief Business Officer Mariusz Jablonski (left-to-right) at the event, which took place in San Diego, California, last week.   #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #diabetes #type1diabetes

What if we could halt diabetes before it becomes a problem? An ambitious study into thousands of children in Poland took an important step in reaching that goal. PolTREG contributed to the study by Prof Artur Bossowski, an endocrinologist and pediatrician at the Medical University of Białystok (Uniwersytet Medyczny w Białymstoku), which found autoantibodies in 3.5% of the children, meaning they have a high risk of developing type-1 diabetes. Yet none were showing any symptoms. A summary appeared as chapter U13 in the abstracts of the 25th Congress of the Polish Diabetes Society (23-25 May 2024): https://lnkd.in/d3MZ3YRj Such early detection is crucial in fighting diabetes, a disease that - on average - has destroyed 80% of the cells that produce insulin by the time it is detected. Total destruction will typically follow within six months, condemning patients to having to take insulin for the rest of their lives. PolTREG is trying to change this. In a Phase I and Phase II clinical study, the company has already proven that its autologous Treg cell therapies can prevent the continuous destruction of the insulin-producing cells in early-onset diabetes, and maintain a patient’s ability to secrete insulin. Together with Prof Bossowski, the company is now hoping to achieve the same result in presymptomatic patients. PolTREG is set to launch a Phase I study in presymptomatic children such as those found in the study, in the hope to delay or even prevent onset of the disease. #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #diabetes #type1diabetes

We are excited to announce that PolTREG will attend the prestigious BIO International Convention! Don't miss the chance to discuss the potential of cell therapies in the treatment of many autoimmune diseases, such as type 1 diabetes or multiple sclerosis. PolTREG has more than 17 years of experience treating patients, and has administered TREG cells to more than 100 people over that period. #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #investing #diabetes #diabetes #type1diabetes #BIO2024