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


— CK0803 are neurotropic, allogeneic, umbilical twine blood derived T regulatory (Treg) cells

— CK0803 represents the firm’s fifth program to obtain IND Clearance using Cellenkos’ proprietary CRANE™ know-how

HOUSTON, Sept. 21, 2022 /PRNewswire/ — Cellenkos, Inc., a medical stage biotech firm that focuses on growing transformative mobile therapeutics for therapy of inflammatory issues and autoimmune ailments, at this time introduced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) software to provoke a Phase 1 security research adopted by a Phase 1b randomized, double blind, placebo management  trial of CK0803, neurotrophic allogeneic Treg cells, in sufferers with amyotrophic lateral sclerosis (ALS). 

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The main goal of the upcoming Phase 1 research is to determine security and tolerability of a number of doses of CK0803 administered intravenously in sufferers with ALS. The objective of the Phase 1b, randomized, double-blinded, placebo-control trial is to offer additional security knowledge and consider the affect of CK0803 on the mixed evaluation of perform and survival (CAFS) that ranks sufferers’ medical outcomes primarily based on survival time and alter in the ALS Functional Rating Scale–Revised (ALSFRS-R) rating.

“This is an exciting opportunity to apply a promising, allogeneic, off-the-shelf, regulatory T cell therapeutic to the treatment of ALS,” mentioned Neil Shneider, MD, PhD, Director of the Eleanor and Lou Gehrig ALS Center at Columbia University and principal investigator for the CK0803 program. “Cellenkos has made an extraordinary commitment to ALS and I am pleased to partner with them on this important therapeutic trial. ALS patients and families need a reason to be hopeful.”

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“We are thrilled to have received IND clearance for our CK0803 program in ALS,” mentioned Tara Sadeghi, Chief Operating Officer of Cellenkos. “With the addition of this new milestone, we now mark our fifth IND clearance as a company and an important neurology program to reach clinical development utilizing our proprietary Treg cell therapies. We are excited by the promise of CK0803 and are honored to work together with Dr Neil Shneider, world renowned neurologist and a leader in the field of neuro-muscular disorders, to bring forward a potentially transformative treatment for ALS patients.”

About Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS) is a uncommon and deadly neurological illness that primarily includes the nerve cells (neurons) accountable for the muscle groups that management limb motion in addition to crucial capabilities reminiscent of speech, swallowing, and respiratory. Approximately 5,000 new sufferers are recognized with ALS yearly and there are over 31,000 sufferers dwelling with ALS in the United States. Most sufferers with ALS die from respiratory failure, normally inside 3 to five years after first onset of signs. Currently there isn’t a remedy and no efficient therapy to halt or reverse the development of this illness.

About CK0803

CK0803 is a novel allogeneic cell remedy product that accommodates sturdy, activated Treg cells that particularly carry neurotropic detection alerts on its cell floor which permits for them to hunt and journey to inflammatory pockets inside the central nervous system. Derived from clinical-grade umbilical twine blood items and manufactured utilizing Cellenkos’ proprietary CRANE™ course of, a number of doses of CK0803 might be generated from a single manufacturing marketing campaign that may be saved in prepared to make use of cryobags at subzero temperature for lengthy interval of time to be made available for affected person use. CK0803 doesn’t require any HLA matching and doesn’t require immune suppression or lymphodepletion previous to its administration. CK0803 might be administered by intravenous infusion in the outpatient setting.

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About Cellenkos®, Inc.

Cellenkos is a clinical-stage biotechnology firm devoted to the growth and commercialization of mobile therapeutics for therapy of inflammatory ailments and autoimmune issues. Cellenkos has 4 lively medical applications: i) CK0801 for therapy of bone marrow failure syndrome together with aplastic anemia and has accomplished its section 1 trial with no security considerations and early efficacy sign with enchancment in blood and platelet transfusion necessities; ii) CK0802 for therapy of COVID-19 related acute respiratory misery syndrome and has accomplished a multi-center, randomized, double blind, placebo management trial with no security concern and early survival sign; iii) CK0803 is being evaluated in section 1 trial for therapy of amyotrophic lateral sclerosis and iv) CK0804 is being evaluated in section 1 trial as an add-on remedy with ruxolitinib for therapy of myelofibrosis sufferers. This research is being executed in collaboration with Incyte prescription drugs. In addition, Cellenkos is growing a sturdy R&D pipeline with genetically modified Treg cells that may permit for therapy of uncommon genetic issues in addition to broader functions together with however not restricted to inflammatory bowel illness, graft vs. host illness and lupus nephritis.

For extra data, please go to www.cellenkosinc.com.

Contact: Stacy Minor


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