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Oral presentation highlights the resolving of inflammation and superior homing to bone marrow of CXCR4-enriched T regulatory cells. Poster presentation includes safety and efficacy data from phase 1b LIMBER-TREG108 study evaluating CK0804, CXCR4 enriched, T regulatory cells, as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib. HOUSTON, Nov. 6, 2023 /PRNewswire/ -- Cellenkos® Inc., a clinical stage biotechnology company focused on developing allogeneic, off-the-shelf, T regulatory (Treg) cell therapies for treatment of rare inflammatory diseases and autoimmune disorders, today announces an oral presentation and poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, which is being held December 9-12, 2023, in San Diego, California. The oral presentation will describe the differentiation and characterization of the CXCR4 enriched Treg cells and their preferential homing to bone marrow to resolve inflammation and decrease TGFβ1 and TGFβ2, in vivo, when compared to control Treg cells. This presentation has also been selected for ASH Abstract Achievement Award. The poster presentation will elaborate on the results of Company's CK0804 Phase 1b trial. The study provides first-in-human safety of multiple infusions of CK0804 in myelofibrosis patients in the ambulatory setting as well as improvement in their blood transfusion requirements and symptom burden. "We are very pleased with the breadth of our oral and poster presentations at this year's ASH meeting, which reflect the promising potential of CK0804 as the backbone for treating myelofibrosis," stated Tara Sadeghi, Chief Operating Officer of Cellenkos® Inc. "Of particular note is the convergence of our CK0804 clinical data with the strong pre-clinical hypothesis and its mechanism of action. This marks dawn of a new era of differentiated Treg cell therapy that could be tailored to specific target tissue and can be investigated in combination with existing approved therapies, especially if there are complimentary mechanisms of action and favorable side effect profiles. The ability to administer CK0804 cells in ambulatory setting without requiring lymphodepletion or hospital admission, embarks the democratization of cellular therapies such that these potentially lifesaving treatments could be made available to patients in the community setting. In addition, the improvement in blood transfusions burden allows for CK0804 to be positioned as a potential novel therapy. We look forward to examining CK0804 in a larger trial." Further details of the presentations are provided below. Oral Presentation Title: CXCR4 Enriched T Regulatory Cells Preferentially Home to Bone Marrow and Decrease Inflammation Date: Saturday, December 9, 2023. Time: 4:30 PM Location: San Diego Convention Center, Room 6A This oral presentation describes the CXCR4 enrichment of Treg cells using the CRANE™ technology platform and faster migration of CXCR4 enriched cells towards SDF1a as early as 15-minute time point. In vivo, the CXCR4 enriched Tregs preferentially trafficked to bone marrow and exhibit higher expression of CXCL12, CD62L, CD39, CD73 and CXCR5. A decrease in TGFα, TNFβ, IL-13 as well as TGFβ1 and TGFβ2 was also observed. These CXCR4 enriched Treg cells are being examined in phase 1b clinical trial (NCT05423691). Poster presentation Title: A Phase Ib, Open-Label Study of Add on Therapy with CK0804 in Participants with Myelofibrosis and Suboptimal Response to Ruxolitinib Date: Saturday, December 9, 2023 Time: 5:30 PM Location: San Diego Convention Center, Halls G-H This presentation describes the safety and efficacy data from the ongoing phase 1b LIMBER-TREG108 study evaluating CK0804, CXCR4 enriched, T regulatory cells, as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib. This is a single arm study where patients receive 6 infusions of CK0804 at a fixed dose at 100 million Treg cells every 28 days. Clinical data from 5 patients who have completed treatment show early promising results of improvement in blood transfusion as well as relief from symptom burden. Additionally, patients report improvement in their tolerance of anemia and daily activities of life. About Cellenkos®, Inc. Cellenkos® is a clinical-stage biotechnology company located in Houston, Texas, USA, founded in 2016 with the licensing of a proprietary umbilical cord blood T-Regulatory cell therapy platform from The University of Texas at MD Anderson Cancer Center. Being derived from umbilical cord blood, Cellenkos' T-Regulatory cells are naïve, bonafide suppressor cells that resolve inflammation through multiple direct and indirect interactions. Cellenkos is dedicated to the development and commercialization of the allogeneic, off-the-shelf cell-based products for the treatment of rare inflammatory diseases and autoimmune disorders. For more information, please visit . Disclosure MD Anderson has an institutional conflict of interest with Cellenkos® related to this research and has implemented an Institutional Conflict of Interest Management and Monitoring Plan Contact: Stacy Minor [email protected] SOURCE Cellenkos, Inc.