FDA clears application for natural killer cell therapy to treat gastrointestinal cancers
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The FDA cleared an investigational new drug application for CYNK-101, a natural killer cell therapy for the treatment of patients with advanced HER2/neu-positive gastric or gastroesophageal junction adenocarcinoma.
The clearance includes use of the investigational cell therapy in combination with chemotherapy, trastuzumab (Herceptin, Genentech) and pembrolizumab (Keytruda, Merck).
CYNK-101 (Celularity) is a gene-edited, allogeneic natural killer (NK) cell therapy comprising human placental hematopoietic stem cells that are genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant.
“Gastric cancer represents the fifth most common cancer worldwide and, in advanced stages of the disease, continues to be associated with less-than-desirable survival outcomes despite recent advances,” Robert Hariri, MD, PhD, founder and CEO of Celularity, said in a company-issued press release. “By enhancing the innate [antibody-dependent cellular cytotoxicity] activity of our placental-derived NK cells, we have developed a cellular therapy platform that holds promise to complement and synergize with a range of antibody treatment strategies across a variety of tumor types.”
The FDA clearance will allow Celularity to proceed with an open-label, nonrandomized phase 1/phase 2A clinical trial. The study will evaluate the safety and preliminary efficacy of CYNK-101 in combination with standard chemotherapy, trastuzumab and pembrolizumab as first-line therapy for patients with advanced Her2/neu-positive gastric and gastroesophageal junction cancer.
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