News

Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0803 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

september 21st 2022

HOUSTON, Sept. 21, 2022 /PRNewswire/ -- Cellenkos, Inc., a clinical stage biotech company that focuses on developing transformative cellular therapeutics for treatment of inflammatory disorders and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1 safety study followed by a Phase 1b randomized, double blind, placebo control trial of CK0803, neurotrophic allogeneic Treg cells, in patients with amyotrophic lateral sclerosis (ALS).

https://www.prnewswire.com/news-releases/cellenkos-receives-fda-clearance-of-investigational-new-drug-ind-application-for-ck0803-for-the-treatment-of-amyotrophic-lateral-sclerosis-als-301629387.html


Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0804 as Add on Therapy to Ruxolitinib for the Treatment of Myelofibrosis

june 14th 2022

HOUSTON, June 14, 2022 /PRNewswire/ -- Cellenkos, Inc., a privately held, clinical stage biotech company that focuses on developing transformative T regulatory cell therapies for rare inflammatory diseases, today 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.

https://www.prnewswire.com/news-releases/cellenkos-receives-fda-clearance-of-investigational-new-drug-ind-application-for-ck0804-as-add-on-therapy-to-ruxolitinib-for-the-treatment-of-myelofibrosis-301567229.html


Global Cord Blood Corporation Announces Entry into Cell Therapy Market by Acquiring Cellenkos and Its Products Rights

april 29th 2022

HONG KONG, April 29, 2022 /PRNewswire/ -- Global Cord Blood Corporation (NYSE: CO, "GCBC" or the "Company"), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services, announced today that the Company will acquire 100% of Cellenkos, Inc ("CLNK") and the rights to develop and commercialize all of its existing and future products worldwide except those related to CLNK's existing collaboration with Incyte Corporation (Nasdaq: INCY, "Incyte"). As of the date hereof, the Company has entered into agreements with the holders of approximately 95% of CLNK outstanding equity interest and GM Precision Medicine (BVI) Limited ("GMPM"). Following the entry into an agreement at substantially the same terms with the remaining 5% holder, at closing, the Company will issue approximately 125 million new shares (on an as-converted and fully diluted basis) valued at US$11 per share and pay US$664 million in cash as total consideration.

https://www.prnewswire.com/news-releases/global-cord-blood-corporation-announces-entry-into-cell-therapy-market-by-acquiring-cellenkos-and-its-products-rights-301536183.html


Cellenkos® Inc. Secures $15 Million Series A Financing to Accelerate the Development of Transformation Cell-Based Therapies

november 4th 2021

HOUSTON and SHANGHAI, Nov. 4, 2021 /PRNewswire/ -- Cellenkos® Inc. ("Cellenkos"), a biotech company focused on developing transformative novel T regulatory (Treg) cell therapies to treat autoimmune and inflammatory disorders, today announced the close of $15 million Series A financing led by BVCF Management Ltd ("BVCF"). Proceeds from this financing will be used to further its development on the Treg cell therapy platform to address high unmet needs in autoimmune and inflammatory disorders."GCBC" or the "Company"), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services, announced today that the Company will acquire 100% of Cellenkos, Inc ("CLNK") and the rights to develop and commercialize all of its existing and future products worldwide except those related to CLNK's existing collaboration with Incyte Corporation (Nasdaq: INCY, "Incyte"). As of the date hereof, the Company has entered into agreements with the holders of approximately 95% of CLNK outstanding equity interest and GM Precision Medicine (BVI) Limited ("GMPM"). Following the entry into an agreement at substantially the same terms with the remaining 5% holder, at closing, the Company will issue approximately 125 million new shares (on an as-converted and fully diluted basis) valued at US$11 per share and pay US$664 million in cash as total consideration.

https://www.prnewswire.com/news-releases/cellenkos-inc-secures-15-million-series-a-financing-to-accelerate-the-development-of-transformation-cell-based-therapies-301416429.html


Cellenkos® Selects Cryoport to Support On-Demand, Flexible COVID-19 Therapy Shipments to Patients in Need

june 22nd 2021

NASHVILLE, Tenn., June 22, 2021 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or "the Company"), a global leader in temperature-controlled supply chain solutions for the life sciences industry, today announced that Cellenkos®, Inc., a privately held, clinical-stage biotechnology company, has selected Cryoport to provide a staged, on-demand, logistics solution for COVID-19 therapy shipments for patients in need."Cellenkos"), a biotech company focused on developing transformative novel T regulatory (Treg) cell therapies to treat autoimmune and inflammatory disorders, today announced the close of $15 million Series A financing led by BVCF Management Ltd ("BVCF"). Proceeds from this financing will be used to further its development on the Treg cell therapy platform to address high unmet needs in autoimmune and inflammatory disorders."GCBC" or the "Company"), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services, announced today that the Company will acquire 100% of Cellenkos, Inc ("CLNK") and the rights to develop and commercialize all of its existing and future products worldwide except those related to CLNK's existing collaboration with Incyte Corporation (Nasdaq: INCY, "Incyte"). As of the date hereof, the Company has entered into agreements with the holders of approximately 95% of CLNK outstanding equity interest and GM Precision Medicine (BVI) Limited ("GMPM"). Following the entry into an agreement at substantially the same terms with the remaining 5% holder, at closing, the Company will issue approximately 125 million new shares (on an as-converted and fully diluted basis) valued at US$11 per share and pay US$664 million in cash as total consideration.

https://www.prnewswire.com/news-releases/cellenkos-selects-cryoport-to-support-on-demand-flexible-covid-19-therapy-shipments-to-patients-in-need-301317091.html


Incyte and Cellenkos Enter into Global Development Collaboration Agreement for CK0804

december 29th 2020

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) and Cellenkos, Inc., a privately held, clinical stage biotech company, 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.

https://www.businesswire.com/news/home/20201230005038/en/


Johns Hopkins Reports Promising Clinical Data in COVID-19 ARDS Treated with Cellenkos' Cord Blood T-Regulatory Cells

july 6th 2020

HOUSTON, July 6, 2020 /PRNewswire/ -- Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy (manufactured by Cellenkos™), published in peer reviewed journal of Annals of Internal Medicine. Both patients were critically ill and intubated (one on ECMO). Both had failed Tociluzimab (Actemra, Roche) and had multiorgan failure. Patients received cell therapy under FDA Emergency Use IND for up to 3 doses. Clinical improvement was evident within 48 hours of first infusion and correlated with concurrent dampening of the cytokine storm as demonstrated by a rapid decline in peripheral biomarkers including lactate, C-reactive protein, and Ferritin as well as decreased blood levels of inflammatory cytokines including IL-6, IFNϒ and TNFα .

https://www.prnewswire.com/news-releases/johns-hopkins-reports-promising-clinical-data-in-covid-19-ards-treated-with-cellenkos-cord-blood-t-regulatory-cells-301088812.html


Cellenkos® Inc. Announces FDA Clearance to Initiate Phase 1 Double- Blinded, Randomized, Placebo-Controlled Trial of Cryopreserved Cord Blood-Derived T-Regulatory Cells (CK0802) for Treatment of COVID-19 Associated Acute Respiratory Distress Syndrome

june 2nd 2020

HOUSTON, June 2, 2020 /PRNewswire/ -- Cellenkos™, a privately held, clinical stage biotech company announced today that the US Food & Drug Administration (FDA) has cleared the way to initiate a Phase 1 clinical trial of CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) for treatment of COVID-19 associated acute respiratory distress syndrome (ARDS). The trial is designed as a randomized, double-blinded, placebo-controlled study to assess safety and preliminary efficacy in this hospitalized patient population.

https://www.prnewswire.com/news-releases/cellenkos-inc-announces-fda-clearance-to-initiate-phase-1-double--blinded-randomized-placebo-controlled-trial-of-cryopreserved-cord-blood-derived-t-regulatory-cells-ck0802-for-treatment-of-covid-19-associated-acute-respirato-301068932.html


Cellenkos Inc. Focuses on the Development of Cell-Therapy for Treatment of COVID-19 Mediated Acute Respiratory Distress Syndrome (CoV-ARDS)

march 17th 2020

HOUSTON, March 17, 2020 /PRNewswire/ -- Cellenkos™, announced today that the company has submitted a clinical development proposal to the Biomedical Advanced Research and Development Authority (BARDA) to start a Phase 1/2 clinical trial with CK0802 for treatment of COVID-19 mediated acute respiratory distress syndrome (CoV-ARDS). Cellenkos will leverage its clinical experience with CK0802 for other inflammatory disorders, including amyotrophic lateral sclerosis and fast-track development of CK0802 to treat respiratory complications caused by COVID-19 infection.

https://www.prnewswire.com/news-releases/cellenkos-inc-focuses-on-the-development-of-cell-therapy-for-treatment-of-covid-19-mediated-acute-respiratory-distress-syndrome-cov-ards-301025278.html


Cellenkos, Inc. Initiates Phase 1 Clinical Trial of CK0801 for Treatment of Bone Marrow Failure Syndromes

june 19th 2019

HOUSTON, June 4, 2019 /PRNewswire/ -- Cellenkos™, announced today 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.

https://www.prnewswire.com/news-releases/cellenkos-inc-initiates-phase-1-clinical-trial-of-ck0801-for-treatment-of-bone-marrow-failure-syndromes-300861217.html?tc=eml_cleartime


Cellenkos, Inc. Announces FDA Clearance of Investigational New Drug Application for CK0801 for Treatment-Resistant Guillain-Barré Syndrome

october 16th 2018

HOUSTON, Oct. 16, 2018 /PRNewswire/ -- Cellenkos™, a clinical-stage biotechnology company, announced that the United States Food and Drug Administration has cleared its Investigational New Drug (IND) application to proceed with a phase I clinical trial of CK0801, allogeneic cord blood-derived regulatory T cells, in patients with treatment-resistant Guillain-Barré Syndrome (GBS). Cellenkos submitted its IND application on September 11, 2018 and received approval on October 11, 2018.

https://www.prnewswire.com/news-releases/cellenkos-inc-announces-fda-clearance-of-investigational-new-drug-application-for-ck0801-for-treatment-resistant-guillain-barre-syndrome-300731539.html?tc=eml_cleartime


Cellenkos, Inc. Announces Neuroinflammation Research Collaboration with The University of Texas Health Science Center at Houston

june 22nd 2018

HOUSTON, June 22, 2018 /PRNewswire/ -- Cellenkos™ and The University Of Texas Health Science Center at Houston today announce a research collaboration for application of cord blood-derived regulatory T cells (CK0801) as adoptive therapy for treatment of neuroinflammatory disorders. The first condition to be studied will include Guillain-Barré Syndrome (GBS), a rare disorder in which the body's immune system attacks part of the peripheral nervous system. Patients with GBS who have not responded to standard therapies will be evaluated for CK0801 therapy.

https://www.prnewswire.com/news-releases/cellenkos-inc-announces-neuroinflammation-research-collaboration-with-the-university-of-texas-health-science-center-at-houston-300671145.html


Presentations

2020

Regulatory T Cells: Treatment for COVID-19?

Dr. Centor discusses the potential use of regulatory T cells to treat patients with acute respiratory distress syndrome associated with COVID-19 with Dr. Franco R. D.Alessio.

https://media.acponline.org/annals/audio/a20-regulatory-t-cells-covid.mp3


Publications

2022

In-depth analysis of SARS-CoV-2–specific T cells reveals diverse differentiation hierarchies in vaccinated individuals. JCI Insight. 2022

https://insight.jci.org/articles/view/156559

2021

Randomized, Multi-Center, Double-Blinded, Placebo Controlled Safety and Early Efficacy Trial of Cryopreserved Cord Blood Derived T-Regulatory Cell Infusions (CK0802) in the Treatment of COVID-19 Induced ARDS. (RESOLVE Trial). Blood, vol. 138, no. Supplement 1, Nov. 2021, pp. 828–828.

https://doi.org/10.1182/blood-2021-153616

Adoptive Therapy with Allogeneic Cord Blood T Regulatory Cells Improves Transfusion Requirement in Bone Marrow Failure Syndromes. Blood, vol. 138, no. Supplement 1, Nov. 2021, pp. 3875–3875

https://doi.org/10.1182/blood-2021-153864

2020

Regulatory T Cells Tested in Patients With COVID-19 ARDS. JAMA, vol. 324, no. 6, Aug. 2020, p. 539.

Regulatory T Cells for Treating Patients With COVID-19 and Acute Respiratory Distress Syndrome: Two Case Reports.” Annals of Internal Medicine, vol. 173, no. 10, Nov. 2020, pp. 852–53.

https://doi.org/10.7326/L20-0681

Adoptive Therapy with Allogeneic Cord Blood T Regulatory Cells Show Safety and Early Clinical Signal in Primary Myelofibrosis.” Blood, vol. 136, no. Supplement 1, Nov. 2020, pp. 41–42.

https://doi.org/10.1182/blood-2020-138585

Adoptive Therapy with Allogeneic Cord Blood T Regulatory Cells Show Safety and Early Clinical Signal in Primary Myelofibrosis.” Blood, vol. 136, no. Supplement 1, Nov. 2020, pp. 41–42.

https://doi.org/10.1182/blood-2020-138585

Adoptive Cord Blood T Regulatory Cell Therapy Leads to Resolution of Inflammation and Decreased Proteinuria in Lupus Nephritis.” Blood, vol. 136, no. Supplement 1, Nov. 2020, pp. 5–6.

https://doi.org/10.1182/blood-2020-140420

Adoptive Therapy with Cord Blood T Regulatory Cells Enhances Anti-Myeloma Efficacy of T Cell Based Immunotherapies.” Blood, vol. 136, no. Supplement 1, Nov. 2020, pp. 26–27.

https://doi.org/10.1182/blood-2020-143142

Combination of Cord Blood T Regulatory Cells with Ruxolitinib Decreases Side Effects and Improves Survival in Xenogenic Graft Vs. Host Disease.” Blood, vol. 136, no. Supplement 1, Nov. 2020, pp. 2–2.

https://doi.org/10.1182/blood-2020-140417

Cord Blood T Regulatory Cells Can Dampen Cytokine Release Syndrome and Improve on Target Efficacy of CD19 CAR T Cells.” Blood, vol. 136, no. Supplement 1, Nov. 2020, pp. 15–16.

https://doi.org/10.1182/blood-2020-138812

2019

Novel CD4+CD8+ Umbilical Cord Blood Regulatory T Cells.” Blood, vol. 134, no. Supplement_1, Nov. 2019, pp. 4446–4446.

https://doi.org/10.1182/blood-2019-131948

Adoptive Therapy with Allogeneic Cord Blood T Regulatory Cells Show Safety and Early Clinical Signal in Primary Myelofibrosis.” Blood, vol. 136, no. Supplement 1, Nov. 2020, pp. 41–42.

https://doi.org/10.1182/blood-2020-138585

Phase I Clinical Trial of CK0801 (Cord Blood Regulatory T Cells) in Patients with Bone Marrow Failure Syndrome (BMF) Including Aplastic Anemia, Myelodysplasia and Myelofibrosis.” Blood, vol. 134, no. Supplement_1, Nov. 2019, pp. 1221–1221.

https://doi.org/10.1182/blood-2019-127702

Single Injection of Cord Blood Regulatory T Cells Can Delay the Manifestations of Systemic Lupus Erythematosus.” Blood, vol. 134, no. Supplement_1, Nov. 2019, pp. 1938–1938.

https://doi.org/10.1182/blood-2019-131436

Adoptive Therapy with Cord Blood Regulatory T Cells Can Treat Graft Vs Host Disease.” Blood, vol. 134, no. Supplement_1, Nov. 2019, pp. 1940–1940.

https://doi.org/10.1182/blood-2019-129395

Cord Blood Regulatory T Cells Prevent Mutiple Myeloma Progression By Suppressing Inflammation.” Blood, vol. 134, no. Supplement_1, Nov. 2019, pp. 3095–3095.

https://doi.org/10.1182/blood-2019-128418

Allogeneic Cord Blood Regulatory T Cells Can Prevent Graft Vs. Host Disease and Preserve Graft Vs Leukemia Effect: Update on Phase I/II Clinical Trial.” Blood, vol. 134, no. Supplement_1, Nov. 2019, pp. 4547–4547.

https://doi.org/10.1182/blood-2019-127726

Previous Years

Third Party, Umbilical Cord Blood Derived Regulatory T-Cells for Prevention of Graft versus Host Disease in Allogeneic Hematopoietic Stem Cell Transplantation: Feasibility, Safety and Immune Reconstitution.” Oncotarget, vol. 9, no. 86, Nov. 2018, pp. 35611–22.

https://doi.org/10.18632/oncotarget.26242

Ex Vivo Generation of Umbilical Cord Blood T Regulatory Cells Expressing the Homing Markers CD62L and Cutaneous Lymphocyte Antigen.” Oncotarget, vol. 9, no. 72, Sept. 2018, pp. 33694–701.

https://doi.org/10.18632/oncotarget.26097

Treg Adoptive Therapy: Is More Better?” Blood, vol. 127, no. 8, Feb. 2016, pp. 962–63.

https://doi.org/10.1182/blood-2015-12-682492

Is There an Expiration Date for a Cord Blood Unit in Storage?” Bone Marrow Transplantation, vol. 49, no. 8, Aug. 2014, pp. 1109–12.

https://doi.org/10.1038/bmt.2014.92

FOXP3 Is a Direct Target of MiR15a/16 in Umbilical Cord Blood Regulatory T Cells.” Bone Marrow Transplantation, vol. 49, no. 6, June 2014, pp. 793–99.

https://doi.org/10.1038/bmt.2014.57

Third-Party Umbilical Cord Blood–Derived Regulatory T Cells Prevent Xenogenic Graft-versus-Host Disease.” Cytotherapy, vol. 16, no. 1, Jan. 2014, pp. 90–100.

https://doi.org/10.1016/j.jcyt.2013.07.009

Dose Intensification of Busulfan in the Preparative Regimen Is Associated with Improved Survival: A Phase I/II Controlled, Randomized Study.” Biology of Blood and Marrow Transplantation: Journal of the American Society for Blood and Marrow Transplantation, vol. 19, no. 3, Mar. 2013, pp. 474–80.

https://doi.org/10.1016/j.bbmt.2012.12.001

Novel Transplant Strategies for Generating Graft-versus-Leukemia Effect in Acute Myeloid Leukemia.” Current Opinion in Hematology, vol. 18, no. 2, Mar. 2011, pp. 98–104.

https://doi.org/10.1097/MOH.0b013e328343b858

Prophylaxis of Graft-Versus-Host Disease in Unrelated Donor Transplantation With Pentostatin, Tacrolimus, and Mini-Methotrexate: A Phase I/II Controlled, Adaptively Randomized Study.” Journal of Clinical Oncology, vol. 29, no. 3, Jan. 2011, pp. 294–302.

https://doi.org/10.1200/JCO.2010.30.6357

Donor-Recipient Mismatches in MHC Class I Chain-Related Gene A in Unrelated Donor Transplantation Lead to Increased Incidence of Acute Graft-versus-Host Disease.” Blood, vol. 114, no. 14, Oct. 2009, pp. 2884–87.

https://doi.org/10.1182/blood-2009-05-223172

Ex Vivo Expanded Umbilical Cord Blood T Cells Maintain Naive Phenotype and TCR Diversity.” Cytotherapy, vol. 8, no. 2, 2006, pp. 149–57.

https://doi.org/10.1080/14653240600620812