“PT101, the lead program in our pipeline of modular protein therapeutics, has the potential to transform the standard of care for patients with a wide array of autoimmune diseases by modulating the immune system through the body’s natural mechanisms, rather than suppressing it,” said Rahul Kakkar, MD, chief executive officer of Pandion. “We are extremely pleased to announce the commencement of this first-in-human trial less than three years after we launched Pandion and began discovery work on PT101.”
The Phase 1 clinical trial will assess the safety, tolerability, and pharmacokinetics of PT101 in healthy volunteers and will include measures of its pharmacodynamic and immuno-modulatory activity. The trial is designed to demonstrate the safety of PT101 and confirm its ability to expand regulatory T cell populations in human subjects. Pandion intends to investigate PT101 as a treatment for patients with ulcerative colitis and other autoimmune diseases.
In preclinical studies, PT101 demonstrated highly potent and selective expansion of regulatory T cells across a broad dose range. Toxicology studies with PT101 further support a wide therapeutic window and no evidence of toxicity associated with treatment.
“Significant need remains in the treatment of many autoimmune and inflammatory conditions,” said Jo Viney, PhD, chief scientific officer of Pandion. “Treatment with low doses of interleukin 2 to expand regulatory T cells has shown promise in treating autoimmune diseases, but a narrow therapeutic index and frequent dosing make such therapy challenging. PT101’s novel, proprietary design has achieved high selectivity for the expansion of regulatory T cells. We look forward to evaluating PT101’s safety and selectivity in the clinic this year.”
Source: Company Press Release