ImmunityBio reports 64 subjects complete apheresis collection in NK2022, NK2023

ImmunityBio (IBRX) announced the completion of manufacturing engineering programs, NK2022 and NK2023, establishing a leukapheresis-to-manufacturing pathway for its autologous memory cytokine-enhanced natural killer cell therapy platform. In addition, a Phase I program combining M-ceNK with Anktiva was completed in patients with relapsed or refractory tumors demonstrating safety following infusion of the M-ceNK drug product. Collectively, these programs enrolled 74 subjects, including both healthy donors and patients with cancer, and generated the foundational process development and robotic automation datasets required to support first-in-human clinical translation. Across both programs, 64 subjects successfully completed apheresis collection across healthy and cancer subjects without procedure-related serious adverse events. Collected cells were stored and used for process development and validation. Among the 64 completed apheresis subjects, 10 cancer subjects received their collected cells following ImmunityBio’s NK cell enrichment process. A total of 23 doses were administered to patients demonstrating successful repeat dosing and cryo-banking of M-ceNK cells. No SAEs were reported in the 10 cancer subjects during their treatment cycles. Post-collection immune profiling demonstrated preserved NK cell activity and phenotype in healthy donors and in cancer patients, including those with prior exposure to systemic therapy. Critically, NK cells derived from cancer patients demonstrated cytotoxic activity equivalent to that of healthy donor-derived NK cells against NK-resistant cell lines representing multiple histologies, including breast, Merkel cell, ovarian, chordoma, medulloblastoma, glioblastoma, adenocarcinoma, and lymphoma. Manufacturing feasibility data from NK2022 and NK2023 directly enabled ImmunityBio’s Phase 1 dose-escalation trial evaluating autologous M-ceNK cells in combination with nogapendekin alfa inbakicept-pmln in patients with relapsed or refractory solid tumors. 10 patients were enrolled in the treatment cohort and received weekly intravenous M-ceNK infusions combined with subcutaneous ANKTIVA(R) administered every two weeks.