CYNK-101 has previously been granted fast track and orphan drug designation.
The first patient has been dosed in Celularity’s phase 1/2a clinical trial of CYNK-101, an investigative cell therapy for treating advanced HER2+ gastric and gastroesophageal junction (G/GEJ) cancers.
“It is well understood that gastric cancer has less than desirable survival outcomes,” Robert Hariri, MD, PhD, founder, chairman and chief executive officer, Celularity, said in a statement.1 “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.”
The clinical trial is primarily investigating the safety and efficacy of CYNK-101 in combination with trastuzumab (Herceptin; Genentech) and pembrolizumab (Keytruda; Merck) in patients with advanced G/GEJ cancers, as measured by dose-limiting toxicities and the maximum tolerated dose. Overall response rate is also a primary endpoint, while secondary endpoints include progression-free survival, duration of response, response conversion, treatment-emergent adverse events, replication competent lentivirus, and overall survival.
“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 tumors. Natural killer (NK) cells possess inherent direct anti-solid tumor activity, recruit non-cross resistant anti-tumor T cells, and may induce memory T cells for long-term anti-cancer immune surveillance,” Darren Sigal, MD, head, gastrointestinal cancer section, The Scripps Cancer Research Institute, added to the statement.1
CYNK-101 is a novel, allogeneic, CD34+, NK cell therapy modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to enhance antibody-dependent cell-mediated cytotoxicity (ADCC). The therapy was granted orphan drug designation by the FDA in February 2022.2 It has also been granted fast track designation.
“We believe NK cells are poised to be the key components of multipronged therapeutic strategies for cancer. It is our understanding that we administered what is the highest dose of allogeneic NK cells so far over a 21-day period. Those cells were derived from human placental hematopoietic stem/progenitor cells and genetically modified to express a variant of CD16 to enable high affinity and enhance antibody dependent cell mediated cytotoxicity. We administered 36 X 106 transduced CYNK-101/kg weekly for four weeks in combination with pembrolizumab and trastuzumab to a patient with Her2 positive gastroesophageal carcinoma. All infusions occurred in the outpatient setting,” principal investigator Martin Gutierrez, MD, chief, thoracic oncology, John Theurer Cancer Center – Hackensack Meridian Health, added to the statement.1