▎ WuXi AppTec content team editor
Recently, Celularity announced that the US FDA has granted it the fast-track qualification of CYNK-101 fast-track cell therapy for genetic modification and cryopreservation of human placental hematopoietic stem cell derived natural killing (NK) cells. A Phase 1/2a clinical trial will evaluate the therapy in combination with standard chemotherapy, anti-HER2 antibody trastuzumab, and PD-1 inhibitor Keytruda (pembrolizumab) for first-line treatment of patients with locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. CYNK-101 is a placenta-derived allogeneic NK cell therapy that has been genetically engineered to enhance antibody-dependent cytotoxicity (ADCC) in synergy with approved antibody therapy drugs.
Stomach cancer is the fifth most common cancer in the world. Despite recent improvements in treatment quality and options, advanced gastric cancer remains one of the most difficult to cure, with a median overall survival (OS) of 10-12 months and a 5-year overall survival rate of about 5-20%. Further efforts are needed to alleviate patient-associated symptoms, improve tumor response rates, and prolong progression-free survival (PFS) and OS while balancing the toxicity of the therapy. In May 2021, the FDA accelerated approval of Keytruda plus trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2+G/GEJ cancer.
Image source: Celularity's official website
CYNK-101 cells are genetically engineered to express a high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant on the surface of NK cells. CD16 is one of the important mechanisms that drive ADCC. In vitro studies have shown that CYNK-101, in combination with monoclonal antibodies, exhibits a higher and longer-lasting ADCC response.
Dr. Robert Hariri, founder, president and CEO of Celularity, participates in discussions on new treatment models at the WuXi AppTec Global Forum