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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
About this update from Celularity Inc.
[{"type":"text","content":"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 FLORHAM PARK, N.J., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-101, which is being developed in combination with standard chemotherapy, trastuzumab and pembrolizumab in patients in first-line locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. CYNK-101 is an investigational genetically modified NK cell therapy designed to synergize with approved antibody therapeutics through enhanced antibody-dependent cellular cytotoxicity (ADCC). Robert Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity, said, “We are extremely excited to receive this fast track designation and the support from the FDA for our investigational genetically modified NK cell therapy in the first-line setting of G/GEJ cancers. CYNK-101 is built on the foundation of our unique placental-derived source material, which as compared to other cell sources, has naturally enhanced proliferative potential (or “stemness”), that has been shown to be a determinant of persistence and efficacy potential. Using novel genetic engineering, we have enhanced the ability of CYNK-101 cells to synergize with approved antibodies and provide a novel and potentially non-cross resistant...