Cellenkos, Inc. announced that its CK0801, an allogeneic T regulatory cell therapy derived from cord blood, has received Orphan Drug Designation from the FDA for the treatment of aplastic anemia, a rare bone marrow disorder.
This designation provides Cellenkos with incentives to further develop CK0801, which has shown promising Phase 1 clinical trial results, including durable transfusion independence in some patients who did not respond to standard treatments.
The company is planning a registration trial for CK0801 in the second half of 2025 to support its potential approval for this underserved patient population.
Cellenkos is a clinical-stage biotechnology company focused on developing off-the-shelf Treg cell therapies for inflammatory and autoimmune diseases.
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