FDA Grants Fast Track Status to Cellenkos for ALS Cell Therapy
The U.S. Food and Drug Administration has granted Fast Track designation to CK0803, an investigational regulatory T-cell therapy developed by Houston-based Cellenkos. The treatment, which aims to address the neuroinflammatory drivers of amyotrophic lateral sclerosis, is the first of its kind to receive this expedited regulatory status.
The designation follows promising initial evaluations where the therapy demonstrated a 60% reduction in neurofilament light chain levels and a 200% increase in plasma IL-10. By utilizing cord blood-derived cells engineered to express specific neurotropic markers, CK0803 is designed to cross the blood-brain barrier and migrate toward sites of active inflammation. Once at the injury site, the cells work to suppress harmful microglial activation and restore immune homeostasis.
Dr. Simrit Parmar, founder of Cellenkos, noted that the therapy addresses a critical need in a disease where median survival remains limited to three years from symptom onset. Current clinical trials, including a Phase I/Ib safety study, involve a regimen of nine infusions without the need for conditioning chemotherapy or specialized HLA matching. Beyond ALS, the company is exploring whether the platform’s mechanism—targeting inflammatory chemokine gradients rather than disease-specific antigens—could offer solutions for other neurodegenerative conditions like Alzheimer’s, Parkinson’s, and multiple sclerosis.
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