Cellenkos Initiates CK0801 Trial for Bone Marrow Failure Syndromes

Cellenkos announced the initiation of a Phase 1 Clinical Trial of CK0801, a first-in-class, allogeneic cord blood-derived T-regulatory cell product, for treatment of patients with bone marrow failure syndromes, including aplastic anemia, hypoplastic myelodysplasia, and primary myelofibrosis. These syndromes are characterized by uncontrolled attack of disease-driving cytotoxic T-cells that lead to an inflammatory microenvironment and inhibition of normal blood cell production in the bone marrow. CK0801 delivers healthy regulatory T-cells that home to sites of bone marrow inflammation and suppress the cytotoxic T-cells, allowing normalization of blood cell production.

"This Phase 1 trial of CK0801 in bone marrow failure syndromes represents an important milestone for Cellenkos," said Elizabeth J. Read, MD, Chief Technology Officer at Cellenkos. "Cellenkos' programs include development of cord blood-derived T-regulatory cell products for clinical application to hematologic diseases, graft vs. host disease, neuro-inflammatory disorders, and autoimmune diseases. We aim to demonstrate that this novel cellular product is not only safe, but also capable of providing transformative clinical benefit to a range of serious illnesses."

The Phase 1 clinical trial of CK0801 in bone marrow failure syndromes will be led by Tapan Kadia, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center in Houston, Texas.

Bone marrow failure syndrome refers to a group of life-threatening diseases with defective production of red blood cells (which leads to anemia), white blood cells (which leads to severe infections), and platelets (which leads to bleeding). Increasing evidence supports the role of immune dysfunction and uncontrolled inflammation, as well as defective T-regulatory cells, in the generation and propagation of bone marrow failure syndromes. This inflammatory process can be reversed by normal T-regulatory cells, leading to improved bone marrow function, which may translate into clinical benefit. Bone marrow failure remains an incurable disease except for those patients who are eligible to receive an allogeneic stem cell transplantation.

CK0801, is a first-in-class, allogeneic, cord blood-derived T-regulatory cell product, developed from Cellenkos' proprietary manufacturing platform that overcomes immune dysfunction by inhibiting key drivers of inflammation. CK0801 contains robust regulatory T-cells derived from healthy donor cord blood units, and is manufactured at Cellenkos' GMP manufacturing facility in Houston, Texas. The first CK0801 IND was approved by the U.S. Food and Drug Administration (FDA) in June 2018.

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