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Celularity Announces Treatment of First Patient in Phase 1/2a Clinical Trial for NK Cell Therapy CYNK-101, in Development for the First-Line Treatment of Advanced HER2 Positive Gastric and Gastroesophageal Junction (G/GEJ) 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 U.S. Food and Drug Administration (FDA) granted both Fast Track Designation and Orphan Drug Designation to CYNK-101 in first line metastatic HER2 positive gastric and gastroesophageal junction cancers Phase 1/2a clinical trial is investigating the safety and efficacy of CYNK-101 in combination with trastuzumab and pembrolizumab in patients with G/GEJ cancer FLORHAM PARK, N.J., July 27, 2022 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, today announced that the first patient has been treated with CYNK-101, a novel allogeneic off-the-shelf human placental CD34+ stem cell derived NK cell therapeutic candidate that is genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to enhance antibody-dependent cell-mediated cytotoxicity (ADCC). Earlier this year, CYNK-101 was granted both a Fast Track Designation and an Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of human epidermal growth factor receptor 2 (HER2) positive G/GEJ cancer. “It is well understood that gastric cancer has less than desirable survival outcomes,” said Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. “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 enhance the ability of CYNK-101 cells to synergize with approved antibodies and provide a novel, potentially non-cross resistant therapy that we believe will be effective in improving the lives of patients with G/GEJ cancers as well as a broad range of other indications.” Dr. Darren Sigal, head of the gastrointestinal cancer section at The Scripps Cancer Research Institute, commented, “The dosing of the first patient in Celularity CYNK-101 gastric cancer program is an exciting milestone in the clinical development of cell therapies in solid tumo...