Business
Celularity Reports First Quarter 2022 Financial Results and Provides Corporate Update
Ongoing Phase 1 study of unmodified placental-derived natural killer (NK) cell therapy candidate, CYNK-001, in acute myeloid leukemia (AML) continues
About this update from Celularity Inc.
[{"type":"text","content":"Ongoing Phase 1 study of unmodified placental-derived natural killer (NK) cell therapy candidate, CYNK-001, in acute myeloid leukemia (AML) continues enrolling new cohorts to reflect adjustments to treatment regimen and dosing as outlined in December 2021Ongoing Phase 1 study of CYNK-001 in glioblastoma multiforme (GBM)U.S. Food and Drug Administration (FDA) granted Fast Track designation to genetically modified placental-derived NK cell therapy candidate, CYNK-101, in first line metastatic HER2/neu positive gastric and gastroesophageal junction cancers; Phase 1/2a study is ongoingFDA granted an Orphan Drug Designation to CYNK-101 for the treatment of gastric/gastroesophageal junction cancers FLORHAM PARK, N.J., May 16, 2022 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, today announced financial results for the first quarter ended March 31, 2022, and provided a corporate update. “We have continued to achieve multiple transformational milestones and make significant progress this year with three ongoing Phase 1 clinical trials of two investigational drugs, CYNK-001 and CYNK-101, both of which have been granted Fast Track and Orphan Drug Designations for certain indications,” said Robert J. Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity. We expect to have data readouts for all three ongoing Phase 1 programs later this year. As such, we believe we are well-positioned to continue executing our business strategy and developing cellular therapies for cancer, infectious and degenerative diseases that leverage our proprietary placental-based technology platform.” First Quarter Clinical and Regulatory Updates CYNK-001 for the Treatment of AML and GBM: CYNK-001 is Celularity’s unmodified cryopreserved human placental hematopoietic stem cell-derived NK cell therapy candidate that is enriched with CD56+/CD3- NK cells and expanded from human placental CD34+ cells. CYNK-001 is currently being investigated in two Phase 1 clinical trials, in AML and in GBM, with data readouts expected in the second half of 2022.Celularity continues to enroll new cohorts in both arms of the Phase 1 AML study with clinical trial protocol adjustments communicated in December 2021, wh...