PolTREG S.A. announced it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO), covering the manufacturing of T-regulatory cells (T-reg) to treat Type-1 Diabetes (T1D), and ways the therapy is administered. The US allowance constitutes an important addition to the intellectual property portfolio covering PolTREG’s autoimmune therapies.
The US patent application covers the manufacturing of Treg cells, the formula of the cellular medicinal product containing Treg cells, and the ways the therapy is administered in T1D patients.
Many of PolTREG’s patent submissions are primary in the field, given that its team performed the first-in-human trials with Treg cell therapies in graft-versus-host disease in 2007-2009.
PolTREG’s portfolio of patents and patent applications, in U.S. and Europe, includes the formulation of polyclonal and engineered Treg products, unique manufacturing elements of these cell therapies, details of patient recruitment and clinical efficacy. A number of the patents have been licensed from the Medical University of Gdańsk to PolTREG through Prof Trzonkowski, who was responsible at the university for the research behind these patents.
PolTREG boasts the most advanced pipeline for Treg cell therapies in autoimmune disease, with its flagship drug candidate, PTG-007, in clinical studies for two indications in T1D and two in Multiple Sclerosis (MS).
Upcoming milestones in 2024
H1 2024
- Results of a long-term efficacy and safety study of PTG-007, in which the company followed early-onset T1D patients over a period of 10 years
H2 2024
- Initiate Phase 2 clinical trial of PTG-007 in presymptomatic T1D patients
- Initiate Phase 1/2a trial in relapsing-remitting (RRMS) patients
- Initiate Phase 1/2a trial in primary progressive (PPMS) patients
- Preclinical proof-of-concept for product(s) from engineered Treg pipeline
About Treg Cells
T-regulatory cells (Treg) are the regulators of the immune system, seeing to it that other leukocytes do not attack the body’s own cells. PolTREG has developed patented processes by which it takes Treg from a patient’s own body, multiplies them ex vivo, and then injects them back in the patient’s own bloodstream for therapeutic effect. Treg therapeutics have advantages over traditional drugs in that they only act at the site of the inflammation, and switch off when the inflammation is over. A Phase 2 clinical study in T1D showed half of patients in clinical remission 24 months into the study, demonstrating the strong potential PolTREG’s cell therapies have to become powerful disease-modifying treatments.
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