PolTREG Identifies Key Biomarker for Efficacy in Pediatric Type 1 Diabetes

Polish biotechnology company, PolTREG S.A. (Warsaw Stock Exchange: PTG)  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 results are from a two year follow-up of 36 patients who had participated in a randomized, placebo-controlled Phase 1/2 clinical trial. This three-arm trial had earlier shown that 50% of PTG-007-treated patients in combination with rituximab were still in remission after 24 months. The main finding of the study was that combined treatment with autologous T-regulatory cells (Treg) and rituximab is superior to monotherapy in T1D.

PolTREG Chief Executive Officer, Piotr Trzonkowski, commented, “This peer-reviewed scientific publication adds to our growing excitement about the potential of polyclonal Treg therapies. We have treated over 100 patients with our cell therapy at our facility over the last 17 years. This has afforded us a wealth of data and unrivalled experience with how T1D and other autoimmune diseases respond to various treatments, including our polyclonal Treg cell therapies and – starting next year – engineered Treg therapeutics.

“Having a biomarker of efficacy, like PD-1+ T-cells, could facilitate doctors’ ability to monitor their patients’ responses to therapy. We already use this data to build new cell products and design next trials towards marketing authorisation. It shows the strength of our unique approach of using the experience from working with patients as the basis to build our portfolio.”

The company manufactures its Treg therapeutics at its wholly-owned GMP-certified manufacturing facility, one of Europe’s largest and most advanced, with over 2,100 sqm of laboratory space and 15 production lines.

PolTREG’s market cap stands at $256.49M and the company’s shares are up 10.49% year to date.

About PolTREG

PolTREG is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership. The company will launch Phase 2 trials for PTG-007 to treat Multiple Sclerosis (MS) in the second half of 2024, for RRMS and PPMS. PolTREG also has engineered Tregs, including CAR-Tregs, antigen-specific Tregs and TCR-Tregs, in the preclinical stage. PolTREG has completed four clinical trials with more than 100 patients treated with Tregs. For more information please visit www.poltreg.com.

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PolTREG Identifies Key Biomarker for Efficacy in Pediatric Type 1 Diabetes

Catie Corcoran

Biotech Editor