HOUSTON, Feb. 6, 2018 /PRNewswire/ -- Cellenkos, Inc., a clinical-stage biotechnology company focused on developing universal donor cell therapeutics derived from cord blood (CB) for the treatment of autoimmune diseases and inflammatory conditions, today announced the successful registration of its stand-alone, manufacturing facility as GMP (good manufacturing practice) compliant with U.S. Food and Drug Administration (FDA).
News
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 .
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.
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 4th 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
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.
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.
Cellenkos™, Inc. Announces FDA Clearance of Investigational New Drug Application for CK0801 for Bone Marrow Failure Syndromes
June 10th 2018
HOUSTON, June 10, 2018 /PRNewswire/ -- Cellenkos™, Inc., a clinical-stage biotechnology company, today announced that the United States Food and Drug Administration has cleared the Investigational New Drug (IND) application which allows for Cellenkos™ to proceed with a phase I clinical trial of CK0801, 3rd party cord blood derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis. Cellenkos™ submitted its IND application on May 11, 2018. The Phase I clinical trial of CK0801 will commence in the third quarter of 2018 at The University of Texas MD Anderson Cancer Center, Houston, Texas.
Cellenkos, Inc. Announces Alick Sun as Senior Vice President for Corporate and Business Development
April 13th 2018
HOUSTON, April 13, 2018 /PRNewswire/ -- Today, Cellenkos Inc. announced the appointment of Alick Sun as Senior Vice President for Corporate & Business Development, further strengthening its executive team as the company continues reinforcing the foundation for long-term growth. He will be responsible for leading all business and corporate development activities. Alick Sun is the senior VP of Golden Meditech Holdings Limited, and holds a concurrent position in Cellenkos. Golden Meditech is an integrated healthcare group in China and a major shareholder of Cellenkos.
https://www.prnewswire.com/news-releases/cellenkos-inc-announces-alick-sun-as-senior-vice-president-for-corporate-and-business-development-300629354.html
Cellenkos Inc. Appoints Tara Sadeghi as Senior Director of Clinical Operations
December 1st 2017
HOUSTON, Dec. 1, 2017 /PRNewswire/ -- Cellenkos Inc., an early stage clinical biotechnology company developing umbilical cord blood derived T-regulatory (Treg) cellular therapies for the treatment of autoimmune diseases and inflammatory disorders, announced today that Tara Sadeghi was appointed as Senior Director of Clinical Operations. Ms. Sadeghi joins Cellenkos, where she will provide senior oversight to clinical operations and ensure quality execution of all projects. “We are excited to have an experienced management team to which Tara Sadeghi brings over 25 years of clinical research experience, leadership and impeccable attention to detail. Her warmth of character and level of professionalism make her an outstanding fit with the Cellenkos family,” said Cellenkos Chief Medical Officer, Simrit Parmar, MD.