LOS ANGELES, CA — March 13, 2026 — Leads & Copy — ImmunityBio, a commercial-stage immunotherapy company (NASDAQ: IBRX), has announced the successful completion of manufacturing engineering programs NK2022 and NK2023. These programs have established a safe, reproducible, and scalable pathway for manufacturing its autologous memory cytokine-enhanced natural killer (M-ceNK) cell therapy platform.
A Phase I program (QUILT-3.076; NCT04898543) combining M-ceNK with ANKTIVA® (nogapendekin alfa inbakicept-pmln) has also been completed. The program demonstrated safety following infusion of the M-ceNK drug product in patients with relapsed or refractory tumors.
Collectively, the NK2022, NK2023, and QUILT-3.076 programs enrolled 74 subjects, including healthy donors and cancer patients. The programs generated the foundational process development and robotic automation datasets required to support first-in-human clinical translation.
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.
According to Patrick Soon-Shiong, MD, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, the data demonstrates that potent NK cell therapy can be manufactured at scale and administered safely, potentially offering a reliable autologous source of potent NK cells. He also stated that 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.
The Phase 1 dose-escalation trial (QUILT-3.076; NCT04898543) evaluated autologous M-ceNK cells in combination with nogapendekin alfa inbakicept-pmln (ANKTIVA®) in patients with relapsed or refractory solid tumors. Ten 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. All infusions were performed in an outpatient setting.
The cancer types treated in the trial included Breast (N=4), Colon (N=1), Duodenum (N=1), Renal (N=1), Pancreatic (N=1), Rectal (N=1), and Osteosarcoma (N=1). The range of M-ceNK infusions was 2 to 5 bags infused with ANKTIVA® subcutaneously. There were zero (0%) TRAE Grade 4 or 5 and 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.
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<0.01 and p<0.001, respectively), with confirmed in vivo persistence of functional M-ceNK cells. M-ceNK treatment also significantly increased MHC-Class I expression on residual tumor cells (p<0.0001), suggesting a potential dual mechanism: direct NK cell mediated tumor killing followed by conversion of residual tumors to a state potentially responsive to immune checkpoint inhibitors.
Tissue microarray analysis demonstrated that 62% of neuroendocrine tumors lack MHC-Class I expression, rendering them resistant to T cell-based immunotherapies but vulnerable to NK cell mediated killing, identifying a substantial patient population with unmet therapeutic need. In standardized cytotoxicity assays, M-ceNK cells demonstrated potent killing activity against the majority of tumor cell lines evaluated, with the greatest cytotoxic activity observed against neuroendocrine tumor models.
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.
ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases.
Source: ImmunityBio
