NantKwest, a California-based clinical-stage biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase 1 trial of haNK, an engineered Natural Killer (NK) cell therapy to treat solid tumors.
NantKwest is specialized in developing next generation NK cell therapy to treat cancers, infectious diseases and inflammatory diseases. The haNK cell therapy platform is an allogeneic, off-the-shelf therapy that is focused on exploiting NK cell’s innate ability to rapidly identify and destroy cells under stress, such as cancer cells, and improving anti-tumor responses through antibody-dependent cell-mediated cytotoxicity. To achieve this, haNK cells have been engineered to express IL-2 and the high-affinity variant of the CD16 receptor.
This Phase 1 study is designed 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 of the trial include determination of objective response rate, progression-free survival, overall survival, and any correlations between tumor molecular profiles and patient outcomes.
Preclinical studies have demonstrated the potential of haNK cells to destroy tumor cells when added along with a variety of therapeutic antibodies. The company intends to initiate this first-in-human clinical study promptly to provide the necessary safety data to rapidly transition to haNK-antibody combination trials.
Dr Patrick Soon-Shiong, Chairman and CEO of NantKwest commented: “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.”
Source: Landmark First-In-Human Clinical Study Launch Using a Genetically Engineered Natural Killer Cell for the Treatment of Cancer. Press Release