Benzinga | Jan 18, 2022 08:14AM EST

Celularity Receives Fast Track Designation From U.S. FDA For Its NK Cell Therapy CYNK-101 In Development For The First-Line Treatment Of Advanced HER2/neu Positive Gastric And Gastroesophageal Junction Cancers

CYNK-101 is an investigational genetically modified natural killer (NK) cell therapy designed to synergize with antibody therapeutics for difficult to treat cancers of high unmet medical need



Phase 1/2a clinical trial will evaluate the safety and preliminary efficacy of CYNK-101 in combination with standard chemotherapy, trastuzumab and pembrolizumab in first-line advanced HER2/neu positive gastric and gastroesophageal junction cancer

Third fast track designation received by Celularity within twelve months from the U.S. FDA -- following fast track designations for CYNK-001, an unmodified NK cell therapy in development for the treatment of acute myeloid leukemia and CYNK-001 in development for the treatment of recurrent glioblastoma multiforme