ImmunityBio Achieves Milestone with Large-Scale NK Cell Production and Cryopreservation from Over 60 Healthy and Cancer Donors

• Methods developed and validated to establish the “World Bank of NK Cells” from healthy donors and cancer patients
• Single apheresis yields up to 5 billion (5×109) highly pure activated memory cytokine-enhanced NK cells (M-ceNK), providing up to 8-10 doses of M-ceNK product per patient
• Manufacturing and cryo-banking process established with finished dosage form of M-ceNK cells available within 12 days from apheresis
• M-ceNK cells successfully cryopreserved with demonstration of retained cytotoxicity against multiple tumor cell lines
• Methods now established in readiness for manufacturing in AI-driven automated robotic systems (NANT Leonardo)
• Combination of M-ceNK with ANKTIVA® successfully completed in Phase 1 safety study (QUILT 3.076)

CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced the successful completion of manufacturing engineering programs, NK2022 and NK2023, establishing a safe, reproducible, and scalable leukapheresis-to-manufacturing pathway for its autologous memory cytokine-enhanced natural killer (M-ceNK) cell therapy platform.

In addition, a Phase I program (QUILT-3.076; NCT04898543) combining M-ceNK with ANKTIVA® (nogapendekin alfa inbakicept-pmln) 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.

Manufacturing Validation

The NK2022 (Cancer and Healthy Volunteers) and NK2023 (Healthy Volunteers) programs (N=64) evaluated the safety of large-volume, non-mobilized leukapheresis and the reproducibility of downstream NK cell enrichment and cytokine-driven memory programming across two distinct donor populations.

Across both programs, 64 subjects successfully completed apheresis collection across healthy and cancer subjects without procedure-related serious adverse events (SAEs). 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.

“These data demonstrate that potent NK cell therapy can be manufactured at scale and administered safely, potentially offering a reliable autologous source of potent NK cells,” said Patrick Soon-Shiong, MD, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The ability to generate up to 5 billion highly pure NK cells from a single apheresis collection, yielding up to 8-10 therapeutic doses within 12 days, opens the possibility of creating the ‘World Bank of Natural Killer Cells’, with NK cells able to be universally donated to any patient without HLA matching.”

QUILT-3.076 Safety Phase I Trial of M-ceNK Cells

Manufacturing feasibility data from NK2022 and NK2023 directly enabled ImmunityBio’s Phase 1 dose-escalation trial (QUILT-3.076; NCT04898543) evaluating autologous M-ceNK cells in combination with nogapendekin alfa inbakicept-pmln (ANKTIVA®) in patients with relapsed or refractory solid tumors. 10 patients were enrolled in the treatment cohort and received weekly intravenous M-ceNK infusions (0.25 to 0.75×109 cells per dose, up to 10 doses) combined with subcutaneous ANKTIVA® administered every two weeks.

• Patient infusions to date: N=10. All infusion performed in an outpatient setting
• Cancer types (2nd line & greater): Breast (N=4), Colon (N=1), Duodenum (N=1), Renal (N=1), Pancreatic (N=1), Rectal (N=1), Osteosarcoma (N=1)
• Range of M-ceNK infusions (2 to 5 bags infused) with NAI subcutaneously
• Safety: Zero (0%) TRAE Grade 4 or 5. Zero (0%) cytokine storm

The combination of autologous M-ceNK cells with ANKTIVA® is mechanistically designed to leverage the IL-15 superagonist activity of ANKTIVA® to sustain in vivo M-ceNK proliferation and persistence following adoptive transfer.

M-ceNK Antitumor Activity in Neuroendocrine Tumors: NCI-Led Preclinical and In Vivo Efficacy Data

Additional translational evidence supporting the M-ceNK platform was presented by K Fousek et al., National Cancer Institute (NCI) at the AACR IO Annual Meeting, 2026.

The AACR IO 2026 presentation reported the first in vivo efficacy data for the M-ceNK platform. In two SCLC xenograft models, M-ceNK cells combined with ANKTIVA produced statistically significant tumor volume reductions (p