Drug intelligence / Profile preview

PDM608

Development stage
Phase 1
Lead developer
Calibr
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

PDM608 is a long-acting, recombinant fusion protein based on granulocyte-macrophage colony-stimulating factor (GM-CSF), engineered using proprietary half-life extension technology to prolong the biological activity of GM-CSF. Developed by Calibr, a division of Scripps Research, it is designed to enhance neuroprotection and modulate immune responses in neurodegenerative diseases such as Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS). In preclinical models, PDM608 demonstrated robust expansion of regulatory T cells (Tregs) and promoted an anti-inflammatory profile with durable effects after a single dose—contrasting with the frequent dosing required for recombinant GM-CSF. The drug aims to reduce neuroinflammation and restore neuronal function by stimulating Treg-mediated immunomodulation. As of 2025, it has completed Phase 1 clinical trials in healthy volunteers assessing safety, tolerability, pharmacokinetics, and pharmacodynamics[1][2][3][4][5][6].

Other names
Long-acting GM-CSF fusion protein
02

Targets

CSF2R (Granulocyte-macrophage colony-stimulating factor receptor)

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