Pandion Announces First Subject Dosed in a Phase 1 Clinical Trial of PT101, an IL-2 Mutein Fc Fusion Therapy for Autoimmune Disease

Trial to evaluate safety and tolerability of PT101, as well as expansion of regulatory T cells

CAMBRIDGE, Mass.--()--Pandion Therapeutics, Inc., a biotechnology company developing modular protein therapeutics for autoimmune disease, today announced the dosing of the first subject in a Phase 1 clinical trial of PT101, a novel and proprietary interleukin 2 (IL-2) mutein Fc fusion protein therapy. PT101 has shown potential to treat autoimmune diseases by expanding populations of regulatory T cells.

“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.”

About PT101
PT101 is an interleukin 2 (IL-2) mutein Fc fusion protein therapy designed to potently and selectively expand regulatory T cells for the treatment of autoimmune disease. Pandion’s Phase 1 trial of PT101 is designed to assess the safety, tolerability, and pharmacokinetics of PT101 after subcutaneous administration, and will also include measures of regulatory T cell expansion and other pharmacodynamic measures.

About Pandion
Pandion Therapeutics is developing modular biologics for autoimmune regulation that are designed to achieve lasting therapeutic outcomes for patients with autoimmune and inflammatory diseases. The company is developing its lead drug candidate, PT101, an IL-2 mutein Fc fusion protein that preferentially expands regulatory T cells, as well as a robust pipeline of systemic immune modulators and tissue-targeted therapeutics focused on the gut, liver, skin, kidneys, and pancreas. Pandion’s approach to developing modular proteins, antibodies and bispecifics includes two key elements: first, the innovative biologics are based on cutting-edge immunomodulators such as an IL-2 mutein or PD-1 agonist that work systemically by activating regulatory pathways of the immune system that suppress uncontrolled autoimmune responses; and second, these immunomodulators can be combined with tissue-selective tethers, building modular proteins and antibodies that target the precise location within the organ to deliver the desired effect. Pandion is backed by leading life sciences investors including Polaris Partners, Versant Ventures, Roche Venture Fund, SR One, BioInnovation Capital, and the JDRF T1D Fund. The company is headquartered in Cambridge, Massachusetts. Please visit


Kathryn Morris
The Yates Network

Sarah McCabe
Stern Investor Relations, Inc.

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