- CK0804 is an off-the-shelf, allogeneic, non-HLA matched, CXCR4 enriched, T regulatory cell therapy product.
- Multiple doses of CK0804 can be safely infused in myelofibrosis patients
- CK0804 reduces symptom burden and induces spleen volume reduction in patients with myelofibrosis who have suboptimal response to prior lines of therapy
HOUSTON, Nov. 7, 2024 /PRNewswire/ -- Cellenkos® Inc., a clinical-stage biotechnology company focused on developing allogeneic, off-the-shelf, T regulatory (Treg) cell therapies for inflammatory disease areas of high unmet needs and autoimmune disorders, today announced that its CK0804 Phase 1b study data in myelofibrosis has been selected for oral presentation at the 66th Annual Meeting & Exposition of the American Society of Hematology (ASH), December 7-10, 2024, in San Diego, California.
The oral presentation will feature the safety and efficacy data from Cellenkos' Phase 1b trial evaluating CK0804 in patients with myelofibrosis who have suboptimal responses to prior therapies, including ruxolitinib. CK0804 is an off-the-shelf, allogeneic, non-HLA matched, CXCR4-enriched Treg cell therapy and is administered in fixed dose of 100 million cells infused every 28 days for 6 doses. CK0804 has shown early promise in addressing this high unmet medical need.
Oral Presentation Details (https://ash.confex.com/ash/2024/webprogram/Paper211587.html)
The study data to be presented demonstrates the safety and efficacy of CK0804 in patients with myelofibrosis who had previously failed standard treatments. Key findings from the trial include significant improvements in symptom burden, spleen volume reduction, blood transfusion dependence, and systemic inflammatory cytokine levels. Importantly, CK0804 was well-tolerated, with no significant drug-related adverse events observed, aside from one patient with a sulfa drug allergy who had an infusion reaction.
Study Highlights
Following the initial success of the Phase 1b trial, the Data Safety Monitoring Board has approved an expansion cohort to further explore the safety and efficacy of CK0804. This expansion includes an induction phase of four weekly doses, followed by five monthly doses, and active participant enrollment is ongoing (NCT05423691).
About Myelofibrosis
Myelofibrosis is a rare, chronic, and progressive blood cancer that causes scar tissue to form in the bone marrow, disrupting the production of normal blood cells. Patients with myelofibrosis often experience debilitating symptoms such as fatigue, spleen enlargement, and night sweats. Approximately 16,000 to 18,500 people in the U.S. are living with myelofibrosis, and those who fail to respond adequately to current treatments including ruxolitinib, face limited options and a poor prognosis. Inflammation is a key driver for disease pathogenesis and progression in myelofibrosis.
About CK0804
CK0804 is an investigational, allogeneic, off-the-shelf Treg cell therapy that leverages the CXCR4/CXCL12 axis to suppress inflammatory cytokines implicated in myelofibrosis pathogenesis. CXCR4 enriched Tregs home faster to bone marrow compared to unmanipulated Tregs. Derived from clinical-grade umbilical cord blood and manufactured using Cellenkos' proprietary CRANE® process, CK0804 does not require HLA matching, making it an ideal therapeutic option for patients in need of prompt intervention. The therapy is administered intravenously and can be infused in an outpatient setting.
About Cellenkos, Inc.
Cellenkos is a clinical-stage biotechnology company based in Houston, Texas, focused on developing off-the-shelf Treg cell therapies for rare inflammatory diseases and autoimmune disorders. The company's portfolio includes four clinical-stage candidates:
Cellenkos' Treg therapies, derived from umbilical cord blood, are designed to provide powerful anti-inflammatory effects and long-lasting immune modulation without the need for donor matching. The company is committed to advancing the development of these promising therapies to improve the lives of patients with rare and underserved conditions.
For more information, please visit www.cellenkosinc.com.
Contact:
Ting Huang
Ting.huang@cellenkosinc.com
SOURCE Cellenkos, Inc.