CK0804 / Cellenkos - LARVOL DELTA

Dose intensive regimen of CK0804 tregs in myelofibrosis (ASH 2025) - "Background : Myelofibrosis (MF) is a clonal hematopoietic stem cell disorder marked by significantinflammation and immune deregulation, that contribute to its pathogenesis and disease (ds.)progression. This more in-depth analysis of the safety run-in phase of evaluating CXCR4 enriched T regscell therapy as addition to ruxolitinib in MF patients with sub-optimal response shows that the immunesystem of responders changed markedly in ways that were different than and complementary to JAKinhibition, with safety and no myelosuppressive adverse events. Extension cohort is currently enrollingwith a promising early data to be presented at the meeting."

Hematological Disorders • Inflammation • Myelofibrosis • CD40LG • CXCL8 • CXCR4 • IL10 • IL6 • TNFA

New data from a dose‑intensive regimen of Cellenkos' CK0804 regulatory T cells (Tregs) in patients with myelofibrosis who had an inadequate response to standard-of-care therapy were presented at the 67th American Society of Hematology (ASH) Annual Meeting… (PRNewswire) - "Spleen volume reduction (SVR): Among 11 evaluable patients, SVR10 was achieved in 45%, SVR25 in 27%, and SVR35 in 18%. Transfusion requirements: All three transfusion‑dependent patients showed a reduction in monthly transfusion needs by the end of the study. Symptom improvement: A greater than 50% reduction in total symptom burden was observed in 78% of patients (9 of 11)....Thrombocytopenic subgroup: All three thrombocytopenic patients tolerated the intensive CK0804 regimen; all had a 100% reduction in symptom burden, and two achieved SVR10."

P1 data • Myelofibrosis • Thrombocytopenia

A Phase Ib, Open-Label Study of Add on Therapy with CK0804 in Participants with Myelofibrosis and Suboptimal Response to Ruxolitinib (ASH 2023) - P1 | "Adoptive therapy with allogeneic, cord blood-derived regulatory T cells (Tregs) (CK0801- HLA 3/ 6 match, fresh infusion) showed safety and early clinical signal in MF (Kadia et al., Blood. The preliminary analysis of this study evaluating CK0804 (CXCR4 enriched T regs cell therapy) as addition to ruxolitinib shows initial safety with no myelosuppressive adverse events and promising clinical activity. The study is actively enrolling participants (NCT05423691). MD Anderson Cancer Center has an institutional conflict of interest with Cellenkos related to the research presented herein."

Clinical • Fibrosis • Immunology • Myelofibrosis • Oncology • CXCR2 • IL13 • TGFA • TGFB1

A Phase Ib, Open-Label Study of Add on Therapy with CK0804 in Participants with Myelofibrosis and Suboptimal Response to Ruxolitinib (ASH 2024) - "Longitudinal analysis of markers of inflammation and follow up data after the 6th infusion showing sustained benefit (including improvements in hemoglobin) will be reported at the conference. Conclusion : This preliminary analysis of run-in phase of study evaluating CXCR4 enriched T regs cell therapy as addition to ruxolitinib shows initial safety with no myelosuppressive adverse events and promising clinical activity."

Clinical • Fatigue • Inflammation • Myelofibrosis • CXCR2 • JAK2

LIMBER-TREG108: Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Cellenkos, Inc. | Trial completion date: Apr 2024 ➔ Dec 2026 | Trial primary completion date: Apr 2024 ➔ Apr 2026

Trial completion date • Trial primary completion date • Essential Thrombocythemia • Myelofibrosis • Neutropenia

Cellenkos Presents Phase 1b Data at ASH 2024 Showcasing the Potential of T-Regulatory Cell Therapy Candidate CK0804 for Myelofibrosis (GlobeNewswire) - P1b | N=24 | TREG108 (NCT05423691) | Sponsor: Cellenkos, Inc | "Key Highlights: (i) Treatment Regimen: Six CXCR4-enriched Treg infusions (106 cells/infusion) were administrated every four weeks in the outpatient setting and were well tolerated (n=9); (ii) Conditioning: No lymphodepletion was administered. No HLA matching was performed. All CK0804 Tregs were cryopreserved and thawed and infused by the bedside; (iii) Spleen Volume Reduction: Four out of six evaluable patients showed spleen volume reduction when measured by MRI;...(iv) Symptom Improvement: All treated patients reported overall improvement in symptom burden, including diminished fatigue and early satiety; (v) Biomarker Analysis: A reduction in levels of TGFβ, a pro-inflammatory cytokine, was observed and correlated with overall clinical response."

P1 data • Myelofibrosis

Cellenkos Announces Oral Presentation at ASH Annual Meeting 2024 Highlighting Phase 1b Clinical Data of CK0804 in Myelofibrosis (PRNewswire) - P1b | N=24 | TREG108 (NCT05423691) | Sponsor: Cellenkos, Inc | "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...Nine patients, with a median of two (range, 1-6) prior lines of treatment, were treated with CK0804; Two patients who were transfusion-dependent showed a reduction in their monthly need for transfusions by the end of the treatment period...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..."

P1 data • Trial status • Myelofibrosis

A phase Ib, open-label study of add-on therapy with CK0804 in participants with myelofibrosis and suboptimal response to ruxolitinib. (ASCO 2024) - P1 | "This preliminary analysis of run-in phase of study evaluating CXCR4 enriched T regs cell therapy as addition to ruxolitinib shows initial safety with no myelosuppressive adverse events and promising clinical activity. Active enrollment of participants to the expansion cohort is ongoing."

Clinical • Myelofibrosis • CXCR2

TREG108: Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Cellenkos, Inc. | Trial primary completion date: Oct 2023 ➔ Apr 2024

Trial primary completion date • Essential Thrombocythemia • Myelofibrosis • Neutropenia

Cellenkos Announces Oral Presentation and Poster Presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition (PRNewswire) - "Cellenkos^® Inc...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 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."

P1 data • Preclinical • Hematological Malignancies • Myelofibrosis • Oncology

Phase Ib, open-label study of add on therapy with CK0804 in participants with myelofibrosis, with suboptimal response to ruxolitinib. (ASCO 2023) - P1 | "Safety data from cohort 1 will be presented. Clinical trial information: NCT05423691."

Clinical • Anemia • Aplastic Anemia • Hematological Disorders • Immunology • Leukemia • Myelofibrosis • CXCL12

Data from Across Incyte’s Oncology Portfolio Accepted for Presentation at the 2023 ASCO Annual Meeting and EHA2023 Hybrid Congress (Businesswire) - "Incyte...today announced that multiple abstracts featuring data from across its oncology portfolio will be presented at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held June 2-6 in Chicago, and at the European Hematology Association 2023 (EHA2023) Hybrid Congress held in Frankfurt, Germany, from June 8-11 and virtually from June 14-15."

Clinical data • P1 data • P1/2 data • P3 data • Chronic Graft versus Host Disease • Diffuse Large B Cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Myelofibrosis • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Cellenkos Announces First Patient Dosed with CK0804 Cell Therapy in LIMBER-TREG108 Clinical Trial (PRNewswire) - "Cellenkos...announced that the first patient was dosed in the Phase 1b LIMBER-TREG108 study evaluating CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib. CK0804 is a novel allogeneic, CXCR4 enriched, T regulatory cell therapy product that utilizes Cellenkos' proprietary CRANE™ technology to generate disease specific products. The LIMBER-TREG108 trial (NCT05423691) is part of a development collaboration between Cellenkos and Incyte....This Phase 1b study will evaluate the safety, pharmacodynamics and immunogenicity of intravenous CK0804, administered monthly for up to 6 doses."

Trial status • Hematological Malignancies • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

TREG108: Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Cellenkos, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2022 ➔ Dec 2022

Enrollment open • Trial initiation date • Essential Thrombocythemia • Myelofibrosis

Global Cord Blood Corporation Announced Cellenkos Receives FDA Clearance of IND Application for CK0804 as Add on Therapy to Ruxolitinib for the Treatment of Myelofibrosis (PRNewswire) - "Global Cord Blood Corporation...is pleased to announce that Cellenkos, Inc. ('CLNK') recently announced that the U.S. Food and Drug Administration ('FDA') has cleared its Investigational New Drug ('IND') application to initiate a Phase 1b, open-label study of CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib."

IND • Hematological Malignancies • Myelofibrosis • Oncology

TREG108: Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Cellenkos, Inc.

New P1 trial • Myelofibrosis

Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0804 as Add on Therapy to Ruxolitinib for the Treatment of Myelofibrosis (Canada Newswire) - "Cellenkos, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1b, open-label study of CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib....This Phase 1b clinical trial is being launched in partnership with Incyte as part of their LIMBER initiative (Leading in MPNs Beyond Ruxolitinib)....'Clearance of this IND is a testament to the quality preclinical data supporting CK0804 through our internal R&D and our ongoing partnership with the University of Texas at MD Anderson Cancer Center as well as the strong chemistry, manufacturing, and control (CMC) and cGMP manufacturing capabilities we have developed internally'."

IND • New P1 trial • Hematological Malignancies • Myelofibrosis • Oncology

"Incyte Collaborates with Cellenkos for CK0804 to Treat Myelofibrosis @Incyte https://t.co/hqk62YLkXG" (@Pharmashot)

Myelofibrosis

Incyte and Cellenkos Enter into Global Development Collaboration Agreement for CK0804 (Businesswire) - "Incyte...and Cellenkos...today announced a development collaboration to investigate the combination of ruxolitinib (Jakafi®) and CK0804, Cellenkos’ cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells, in patients with myelofibrosis (MF). In addition, Incyte has an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications...Per the terms of the agreement, the companies plan to initiate a Phase 1b single arm, open-label study evaluating ruxolitinib in combination with CK0804 in patients with MF."

Commercial • Licensing / partnership • Hematological Malignancies • Myelofibrosis • Oncology