The company plans to promptly initiate this trial, which is believed to be the first ever clinical evaluation of a genetically engineered, allogenic, off-the-shelf, natural killer cell for the treatment of patients with cancer.
NantKwest chairman and CEO Patrick Soon-Shiong said: “We are thrilled to have received notification from the FDA that our first haNK cell therapy program has been authorized to proceed into Phase I clinical trials and are focused on moving swiftly to begin this study.
“The FDA’s authorization to initiate this clinical trial achieves a significant milestone for NantKwest as we begin clinical investigation of the use of haNK cell therapy for the treatment of cancer in a wide range of cancer types.”
NantKwest’s haNK cell therapy platform, developed to be an allogeneic, off-the-shelf therapy, is focused on optimizing the key role that natural killer cells play in mediating innate immunity, enhancing adaptive immune responses, and, specifically in the case of haNK, improving anti-tumor responses via antibody-dependent cell-mediated cytotoxicity (ADCC).
To achieve this objective, haNK cells have been engineered to express IL-2 and the high-affinity variant of the CD16 receptor (V158 FcγRIIIa).
In preclinical studies, the addition of haNK to a variety of therapeutic antibodies has led to increased tumor cell killing when compared to the antibody alone. Thus, this first-in-human clinical study is designed to provide the necessary safety data to rapidly transition to haNK-antibody combination trials.
Dr. Soon-Shiong added: “As only about 10% of patients are born with the high affinity CD16 receptor, we believe the potential for haNK cell therapy to improve patient outcomes for the other 90% of the patient population and become part of the standard-of-care for cancer patients is very compelling.”
The primary objective of the study is to determine the safety of haNK cell monotherapy administered intravenously once per week in up to 16 patients with metastatic or locally advanced solid tumors.
Other objectives include determination of objective response rate, progression-free survival, overall survival, and any correlations between tumor molecular profiles (based on genomics, transcriptomics, and quantitative proteomics) and patient outcomes.