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

-- CK0804 represents the company's fourth program to receive IND Clearance

-- CK0804 is a partnered program with Incyte

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.

CK0804 is a novel allogeneic, CXCR4 enriched, T regulatory cell therapy product that utilizes Cellenkos' proprietary CRANE™ technology to generate disease specific products. This Phase 1b clinical trial is being launched in partnership with Incyte as part of their LIMBER initiative (Leading in MPNs Beyond Ruxolitinib). The study (LIMBER-TREG108) will examine the safety of monthly doses of CK0804 as add on therapy in myelofibrosis patients who will continue treatment with ruxolitinib.

"We are thrilled to have received IND clearance for our CK0804 program in myelofibrosis, marking our fourth IND Clearance as a company and our second hematological malignancy program to reach clinical development," said Tara Sadeghi, Chief Operating Officer of Cellenkos Inc. "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. Our clinical development plans across multiple disease processes utilizes our proprietary CRANE™ technology that allows for us to create disease specific T regulatory cell therapeutics supporting our rich pipeline. We are excited by the promise of CK0804 to offer a potentially transformative treatment for myelofibrosis patients."

"We are pleased to be partnering with Cellenkos to initiate this new LIMBER study evaluating CK0804 and ruxolitinib as we continue to explore new treatment options for patients with myelofibrosis," said Ekaterine Asatiani, M.D., Division Vice President and Head of Early Development at Incyte.

Myelofibrosis is a rare, chronic and progressive blood cancer that is part of a group of diseases known as myeloproliferative neoplasms. In myelofibrosis, scar tissue forms in the bone marrow and impairs its ability to produce normal blood cells. This can result in an enlarged spleen, as well as symptoms such as fatigue, itching and night sweats, which can severely impact a patient's quality of life. About 16,000 to 18,500 people in the U.S. are living with myelofibrosis. Patients who have had a suboptimal response to the standard of care treatment using ruxolitinib have limited options and a poor prognosis.

CK0804 is a novel allogenic cell therapy product consisting of T-regulatory cells that exploit the CXCR4/CXCL12 axis and are derived from clinical-grade umbilical cord blood units and manufactured using Cellenkos' proprietary CRANE™ process. Multiple doses of CK0804 can be manufactured from a single umbilical cord blood unit, where the final cryopreserved product is readily available for use. No requirement for HLA matching to the patients makes CK0804 an ideal therapy that can be infused intravenously, in the outpatient setting.

Ruxolitinib (Jakafi^®) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi^® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

About Cellenkos^®, Inc. Cellenkos is a clinical-stage biotechnology company located in Houston, Texas, USA, founded in 2016 with the licensing of a proprietary umbilical cord blood T-Regulatory cell therapy platform from the University of Texas at MD Anderson Cancer Center.  Being derived from umbilical cord blood, Cellenkos' T-Regulatory cells are naïve, bonafide suppressor cells that resolve inflammation through multiple direct and indirect interactions. Cellenkos is dedicated to the development and commercialization of the allogeneic, off-the-shelf cell-based products for the treatment of rare inflammatory diseases and autoimmune disorders. For more information, please visit www.cellenkosinc.com.

Contact:         
Stacy Minor
bd@cellenkosinc.com

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