FDA Authorizes ImmunityBio to Conduct a Trial of its First-in-Human, Cryopreserved, Memory Cytokine-Enriched NK Cell (m-ceNK) Platform in Solid Tumors - Seite 2

NK cells from aphaeretic blood from 20 subjects, 15 healthy and 5 cancer patient donors, were successfully used to generate m-ceNK cells in an Independent Review Board-approved volunteer study. Mononuclear cells obtained from the apheresis procedure were stimulated in the presence of ImmunityBio’s proprietary cytokine, N-803, for enrichment of primary natural killer cells. A 2 to 3 log-fold expansion of activated NK cells was achieved by the third week of the protocol. These NK Cells are then briefly exposed to a proprietary cytokine cocktail to impart the critical memory-like phenotype, characterized by higher effector responses after a resting period—a key feature of ImmunityBio’s m-ceNK cells. The m-ceNK product is characterized as CD56+ cells that are armed with NK cell activating surface receptors required for proliferation, homing and tumor recognition and binding. Both the healthy- and cancer patient-derived m-ceNK cells killed NK-resistant tumor cells with equal potency when tested against tumor cells of different origins, including breast, Merkel, ovarian, adenocarcinoma, and lymphoma.

ImmunityBio has also developed a novel method of production, which yields multiple clinical-dose forms from a single apheresis product using the company’s proprietary NANT 001 Bioreactor (GMP-in-a-Box), thereby alleviating pressures on supply of starting material. A tailored cryopreservation protocol for maximum shelf-life and potency upon recovery was also established, a necessary precedent for any off-the-shelf product. ImmunityBio is leveraging the unique properties of m-ceNK—including potent cytotoxicity, increased IFN-gamma production, proliferative capacity, activation surface markers and memory response—to establish a propriety autologous product.

QUILT 3.076 Study Details

Cryopreserved m-ceNK cells in combination with Anktiva (N-803) will be tested in this phase 1 study designed to evaluate safety in subjects with locally advanced or metastatic solid tumors. The study will compare the quantity and quality of the m-ceNK cells collected and manufactured from newly diagnosed patients who have not received prior treatment to the m-ceNK cells collected and manufactured from patients who have received at least two prior treatments for their cancer.