FDA Authorizes ImmunityBio to Conduct a Trial of its First-in-Human, Cryopreserved, Memory Cytokine-Enriched NK Cell (m-ceNK) Platform in Solid Tumors
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced it has received FDA authorization to conduct a Phase 1 study to evaluate the safety and preliminary efficacy of its m-ceNK platform combined with its IL-15 superagonist Anktiva (N-803) in subjects with locally advanced or metastatic solid tumors. These NK cells retrieved from the patient and enriched with cytokines have the ability to recognize and kill cancer targets with increased production of interferon-g (IFN-γ), a cytokine demonstrating high activity.
“Nearly two million Americans, including children, will be diagnosed with locally advanced or metastatic solid tumors this year alone and many of these tumor types are difficult to treat,” said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. “Our m-ceNK cells, which are isolated and enriched from the patient after a simple blood draw (apheresis), are characterized by their unique cell-surface marker profile, by their highly desirable feature of immune-memory, and marked by their pronounced anti-cancer activity for weeks to months in duration. These unique properties have made these memory NK cells a research focus for more than a decade and a promising candidate in immunotherapy for solid tumors,” said Soon-Shiong.
“We are excited to launch this next evolution of our NK platform. Based on the novel techniques and cytokine expansion developed at ImmunityBio, a single apheresis will enable 10 to 20 doses of m-ceNK infusions of 0.5 billion NK cells per dose. These autologous and allogeneic cryopreserved memory NK cells could synergize with our engineered off-the-shelf NK-92 cells, as well as with our IL-15 Anktiva superagonist, which stimulates both NK and T cells. We believe the combination of these tools has the potential to place ImmunityBio in a leading position to activate the patient’s immune system in the fight against cancer across both solid and liquid tumors.”
About Memory Cytokine-Enhanced NK Cells (m-ceNK):
In an initial, proof-of-concept clinical study, memory-like NK cells with freshly isolated cytokine-stimulated NK cells demonstrated encouraging results in patients with liquid tumors.1. ImmunityBio has successfully enriched and expanded donor natural killer cells obtained from peripheral blood of donors using a technique called apheresis, to generate a unique NK cell phenotype which exhibits both high cytotoxicity and interferon-g production together with a memory–like effect. These m-ceNK cells, or memory-cytokine enriched NK cells, have been designed for autologous cell therapy, but have also been generated as an allogeneic product from cord blood. m-ceNK provides a unique opportunity in clinics due to its ease of use and potential suitability for use in the ambulatory setting.