US-based immunotherapy firm NantKwest is planning to initiate the Phase I clinical trial for its genetically engineered and allogenic high-affinity natural killer (haNK) cell therapy to treat cancer.
haNK cell therapy utilises the natural killer cells to mediate innate immunity, boost adaptive immune responses and increase anti-tumour responses through antibody-dependent, cell-mediated cytotoxicity (ADCC).
The firm has secured the US Food and Drug Administration (FDA) authorisation for the Investigational New Drug Application (IND) of haNK.
The primary objective of the Phase I trial is to evaluate the safety of haNK cell monotherapy, provided intravenously once per week in approximately 16 patients with metastatic or locally advanced solid tumours.
NantKwest chairman and chief executive officer Patrick Soon-Shiong said: “We are thrilled to have received notification from the FDA that our first haNK cell therapy programme has been authorised to proceed into Phase I clinical trials and are focused on moving swiftly to begin this study.
“The FDA’s authorisation 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.”
The haNK cells have been engineered to express IL-2 and the high-affinity variant of the CD16 receptor (V158 FcγRIIIa) to enhance the anti-tumour responses.
The preclinical studies showed that the combination of haNK with a variety of therapeutic antibodies leads to improved tumour cell killing when compared to the antibody alone.
It is expected that the Phase I study will provide the required safety data to commence haNK-antibody combination trials.
The objectives such as determination of objective response rate, progression-free survival, overall survival, correlations between tumour molecular profiles and patient outcomes will also be established in Phase I.