Celularity Announces Positive DMC Safety Review and Continuation of its Phase I/II CYNK-001-COVID-19 (CYNKCOVID) Study
FLORHAM PARK, N.J., Dec. 1, 2020 /PRNewswire/ — Celularity announced today that the independent Data Monitoring Committee (DMC) completed the first assessment of the ongoing Phase I/II CYNK-001-COVID-19 (CYNKCOVID) study (https://clinicaltrials.gov/ct2/show/NCT04365101) with CYNK-001 off-the-shelf, allogeneic, natural killer (NK) cell therapy in adults with COVID-19. The DMC confirmed the absence of dose-limiting toxicities and recommended to move forward with the trial. Additionally, there was no evidence of worsening of inflammatory biomarkers observed. The observed clinical findings justify the continuation of the trial. Enrollment is ongoing in this multi-center clinical study with active sites in Arizona, Arkansas, California, New Jersey, and Washington.
“We are encouraged that an esteemed group of independent experts in COVID-19 and cellular therapy determined that CYNK-001 was safe in the first participants receiving the treatment on the multi-site national study. Our goal now is to rapidly complete enrollment of the study so we can determine the efficacy of this promising treatment for COVID-19 with the epidemic resurging in the United States and few good treatment options for many patients,” said the national PI for the CYNKCOVID clinical trial, Corey Casper, M.D., M.P.H.
“The administration of NK cells may have the potential to both control viral infection while also coordinating a more effective immune response that could lead to strong and lasting protection against viruses. With the increasing incidence of COVID-19 nationwide, Celularity reaffirms our commitment to the development of CYNK-001 as a potential therapeutic treatment for patients with limited treatment options. Through our collaboration with investigators, we anticipate rapid enrollment culminating in the next DMC review of safety and efficacy data,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder, Chairman and Chief Executive Officer.
The Phase I/II CYNK-001-COVID-19 (CYNKCOVID) clinical trial investigating CYNK-001 is continuing to enroll to the next evaluation milestone where the external, independent DMC will review the phase I data for both safety and efficacy. Celularity continues to accumulate safety data on CYNK-001 across a broad platform of programs including COVID-19, as well as hematologic and solid tumor malignancies.
About NK Cells
NK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.
CYNK-001 is an investigational cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).
Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf allogeneic cellular therapies. Celularity’s innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post-partum placenta. Through nature’s immunotherapy engine – the placenta – Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com