FDA grants fast track designation to natural killer cell therapy for GI cancers
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The FDA granted fast track designation to CYNK-101, a natural killer cell-based therapy for treatment of advanced HER2/neu-positive gastric or gastroesophageal junction adenocarcinoma.
CYNK-101 (Celularity) is a gene-edited, allogeneic natural killer (NK) cell therapy composed of human placental hematopoietic stem cells that are genetically modified to express a high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant.
The therapy is designed to work in combination with pembrolizumab (Keytruda, Merck) — an anti-PD-1 monoclonal antibody — plus standard-of-care therapy.
The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
The agency previously granted fast track status to two other NK cell therapy products from Celularity designed to treat relapsed or refractory acute myeloid leukemia and malignant gliomas.
“We are extremely excited to receive this fast track designation and the support from the FDA for our investigational genetically modified NK cell therapy,” Robert J. Hariri, MD, PhD, founder and CEO of Celularity, said in a company-issued press release. “Using novel genetic engineering, we have enhanced the ability of CYNK-101 cells to synergize with approved antibodies and provide a novel and potentially noncross-resistant therapy to improve the lives of patients with gastric or gastroesophageal junction cancers, as well as a broad range of other indications.”
Celularity is enrolling patients for an open-label, nonrandomized phase 1/phase 2A clinical trial of CYNK-101. The study will evaluate the safety and preliminary efficacy of the investigational therapy in combination with standard chemotherapy, trastuzumab (Herceptin, Genentech) and pembrolizumab as first-line therapy for patients with locally advanced unresectable or metastatic HER2/neu-positive gastric or gastroesophageal junction adenocarcinoma.