NEW YORK – Celularity said on Wednesday that the first HER2-positive gastric cancer patient has received treatment in a Phase I/IIa trial of the investigational cell therapy CYNK-101 following induction treatment with Genentech's Herceptin (trastuzumab), Merck's Keytruda (pembrolizumab), and chemotherapy.
CYNK-101 is an off-the-shelf allogeneic cell therapy comprising placental-derived NK cells that are engineered to enhance antibody-dependent cellular cytotoxicity and resist cleavage of CD16. The US Food and Drug Administration cleared Celularity's investigational new drug application to start human trials of CYNK-101 in November, and granted fast track and orphan drug designation to the treatment for advanced, HER2-positive gastric and gastroesophageal cancer.
In the Phase I/IIa clinical trial, Florham Park, New Jersey-based Celularity is evaluating the safety and preliminary efficacy of the NK cell therapy among about 52 advanced gastric or gastroesophageal cancer patients. The cell therapy is administered together with recombinant human interleukin-2 after patients receive induction therapy with Herceptin, Keytruda, and lymphodepleting chemo.
Patients are eligible to enroll in the trial if their tumors are HER2-positive, as determined by immunohistochemistry and fluorescent in situ hybridization (FISH) or FISH alone. Based on differences in HER2 positivity between cancer types, Celularity is requiring patients' tumors be deemed HER2-positive using FDA-approved companion diagnostics specifically for gastric cancer, in keeping with the language on the Herceptin label.
The company believes that CYNK-101, based on its placental-derived source material and novel genetic engineering approach, has the potential to be more proliferative than other cell therapies and to work synergistically with approved antibodies like Herceptin and Keytruda.