Cellenkos Inc, a clinical-stage biotechnology company developing tissue-directed, cord blood-derived T-regulatory (Treg) cell therapies, announced on Tuesday that the US Food and Drug Administration (FDA) has granted Fast Track designation to CK0803 for the treatment of Amyotrophic Lateral Sclerosis (ALS).

The designation was granted under Section 506(b) of the Federal Food, Drug, and Cosmetic Act in connection with the company's Investigational New Drug (IND) application (IND 28681) for CK0803, described as 'Allogeneic Cord Blood-Derived T-Regulatory Cells Expressing Neurotropic Homing Marker'.

"Fast Track designation strongly validates CK0803 and our underlying platform," said Dr. Simrit Parmar, founder of Cellenkos. "By leveraging enriched, tissue-directed regulatory T-cells derived from healthy, allogeneic, umbilical cord blood, our therapy actively homes to inflamed microglia via the CXCR3/CXCL10 axis. This targeted approach interrupts the inflammation-injury cycle and restores neuroimmune homeostasis-offering transformative potential for neuroinflammatory diseases."

Dr. Parmar added that Fast Track designation allows the company to work more closely with the FDA, "with the goal of bringing a meaningfully different treatment option to a disease where median survival remains just two to three years from symptom onset and no therapy substantially alters the underlying neurodegenerative trajectory for most patients."

Cellenkos believes the biological rationale for CK0803 may extend beyond ALS to other neuroinflammatory and neurodegenerative conditions, including Alzheimer's disease, Parkinson's disease, and multiple sclerosis (MS).