Cell therapy using Tregs in MS headed to Phase 2 trials in Poland

The Polish biotechnology company PolTREG plans to launch Phase 2 trials testing its Tregs therapy — the T-cell-based treatment PTG-007 — in people with multiple sclerosis (MS) in Poland later this year.

The biotech company has earned a Current Good Manufacturing Practice (CGMP) certification for its new manufacturing facility, meaning that it’s been deemed to meet certain safety and quality standards, and that every batch of a product produced there will meet these standards.

By earning the certification, PolTREG can produce its cell therapy candidates directly in its new facility, and becomes eligible to seek permission from Polish regulators to conduct clinical trials there.

PolTREG “announces it has received CGMP certification from Poland’s Chief Pharmaceutical Inspectorate, allowing it to produce cellular therapies (Advanced Therapy Medicinal Products – ATMP) in its own site,” the company said in a press release, which noted that the facility offers more than 2,100 square meters (more than 22,000 square feet) of laboratory space, including 15 production lines.

The company said it will launch trials of PTG-007 in the second half of 2024 in people with MS.

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MS is an autoimmune condition in which the immune system wrongfully targets and causes damage to healthy parts of the nervous system. Various immune cell types, including T-cells and B-cells, are implicated in these inflammatory attacks.

Regulatory T-cells, commonly referred to as Tregs, are a type of immune cell that instead works to control inflammation by keeping the activity of these other immune cells in check. Tregs play an important role in immune tolerance, the mechanisms that prevent the immune system from attacking the body’s own cells.

Because immune tolerance is lost in autoimmune diseases like MS, leveraging the immune-suppressing power of Tregs is of significant interest in treating these conditions.

PolTREG is focused on developing Treg-based cell therapies for autoimmune diseases, touting itself as the first company in the world that has administered therapeutic Tregs to patients.

Its lead candidate PTG-007 is being investigated as a possible treatment for MS and type 1 diabetes. It contains autologous Tregs, meaning cells that originally came from a patient’s own body instead of a donor.

Essentially, Tregs are isolated from a person’s blood sample, multiplied in the lab to millions, and then infused back into the patient’s body. This enriched population of Tregs is expected to help the person’s body quell any aberrant self-reactive immune attacks.

PolTREG had previously conducted an open-label Phase 1b/2a clinical trial to evaluate the safety of autologous Tregs. It involved 14 people with relapsing-remitting MS (RRMS) who had not been treated with any other disease-modifying MS therapies for at least six months before the trial.

Most participants — 11 people — received the Tregs via an infusion into the bloodstream (intravenously) and three received them directly into the spinal canal (intrathecally).

Both administration methods were found to be safe. While some evidence suggested better clinical outcomes after the intrathecal administration, the study was too small to draw any conclusions about the therapy’s effectiveness.

From our brand-new facilities, we can in the future ship these live cells anywhere in Europe within 24 hours. … This is a significant potential expansion in treatment options for patients, and an important consideration as our pipeline of Treg cell therapies comes closer to market.

The company now is planning to launch Phase 2 trials involving people with RRMS and primary progressive MS. PTG-007 is expected to be given along with other standard MS therapies.

PolTREG also is developing a type of engineered Tregs called chimeric antigen receptor (CAR) Tregs for RRMS and PPMS. The approach is similar, but after the Tregs are isolated from a patient, they will be engineered to more specifically target problematic components of the immune system once they’re infused back into the patient.

The company notes that plans are underway to launch first in-human trials of CAR Tregs in MS and amyotrophic lateral sclerosis (ALS) patients early next year.

For PolTREG, having the new CGMP certification will be a great asset for future clinical trials or if the therapy should be approved.

“From our brand-new facilities, we can in the future ship these live cells anywhere in Europe within 24 hours,” said Piotr Trzonkowski, MD, PhD, CEO of PolTREG.

“This is a significant potential expansion in treatment options for patients, and an important consideration as our pipeline of Treg cell therapies comes closer to market,” Trzonkowski added.