NantKwest and ImmunityBio Announce Complete Response in Metastatic Pancreatic Cancer in the First Patient to Receive PD-L1 Tumor-Targeted Natural Killer Cells (PD-L1.t-haNK) Combined with N-803 IL-15 Fusion Protein
NantKwest Inc., (Nasdaq: NK), a clinical-stage natural killer cell-based therapeutics company, today announced results from their Phase 1 trial investigating a novel, first-in-human immunotherapy consisting of NantKwest’s off-the-shelf, PD-L1 tumor-targeted NK cells (NCT04050709). In addition, NantKwest and ImmunityBio, Inc., a privately held immunotherapy company, reported on a compassionate use expanded access IND combining the PD-L1-targeted NK cell with ImmunityBio’s IL-15 fusion protein (N-803) in a patient with metastatic pancreatic cancer who had relapsed after prior standard of care therapy.
The findings on the Phase 1 safety and early signals of efficacy were reported by Patrick Soon-Shiong, M.D., Chairman and CEO of NantKwest, at the J.P. Morgan Healthcare Conference in San Francisco.
“We hypothesize that a common treatment protocol that harnesses both the natural-killer cell and the T cells could be effective in treating cancer across multiple tumor types. This has been supported by the early signals of safety and efficacy in Phase 1 and 2 studies of NantKwest’s natural killer cells in advanced cancers. We recently reported at the 2019 Society for Immunotherapy of Cancer conference (SITC) complete responses in third-line Merkel cell carcinoma and fourth-line head and neck cancers when haNK CD-16 NK cells combined with Pfizer’s PD-L1 antibody, Avelumab, and with ImmunityBio’s N-803, an IL-15 superagonist were administered,” said Dr. Soon-Shiong. “Most recently we reported complete responses using combination therapies which included haNK, Avelumab and N-803 in Triple Negative Breast Cancer. Durable complete responses were observed in these patients who had failed all standards of care therapy for breast cancer. The results were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) in December 2019.”
“The evolution of the next generation NK in our platform was now to enable haNK cells to target tumors by expressing PD-L1 CAR (chimeric antigen receptor) on the surface of haNK NK cells. These PD-L1.taNK NK cells have the properties of targeting PD-L1 on tumors, without the need of an additional PD-L1 checkpoint, Avelumab.”
The FDA authorized the first-in-human safety studies of PD-L1.t-haNK (Quilt 3.064; NCT04050709) at doses of two billion cells administered bi-weekly as outpatients. No dose limiting or treatment-related events were noted in patients treated to date in this first dosing cohort. The study is now enrolling the dose cohort of four billion cells per infusion.