ImmunityBio (NASDAQ: IBRX) announced completion of manufacturing programs establishing a pathway for its autologous memory cytokine-enhanced natural killer cell therapy platform. The company enrolled 74 subjects across programs NK2022, NK2023, and a Phase 1 safety trial.

The programs demonstrated that single apheresis procedures can yield up to 5 billion NK cells, providing 8-10 therapeutic doses per patient with finished products available within 12 days. Among 64 subjects who completed apheresis collection, no procedure-related serious adverse events occurred.

In the Phase 1 trial QUILT-3.076, 10 cancer patients received M-ceNK cell infusions combined with ANKTIVA in an outpatient setting. The trial included patients with breast, colon, duodenum, renal, pancreatic, rectal cancer and osteosarcoma. No grade 4 or 5 treatment-related adverse events or cytokine storm cases were reported.

The manufacturing process successfully preserved NK cell activity in both healthy donors and cancer patients, including those with prior systemic therapy exposure. NK cells from cancer patients demonstrated cytotoxic activity equivalent to healthy donor cells against multiple tumor types.

Preclinical data presented by the National Cancer Institute showed M-ceNK cells combined with ANKTIVA produced statistically significant tumor volume reductions in two small cell lung cancer xenograft models. The treatment increased MHC-Class I expression on residual tumor cells.

The company established methods for automated robotic manufacturing systems and demonstrated successful cryopreservation of M-ceNK cells with retained cytotoxicity against multiple tumor cell lines.