m-ceNK cells / ImmunityBio - LARVOL DELTA

QUILT-3.076 Safety Phase I Trial of M-ceNK Cells (Businesswire) - "Patient infusions to date: N=10. All infusion performed in an outpatient setting; Cancer types (2^nd 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."

P1 data • Breast Cancer • Colon Cancer • Osteosarcoma • Pancreatic Cancer • Rectal Cancer • Renal Cell Carcinoma

Characterization of the anti-tumor efficacy of memory cytokine enriched NK cells against tumors with neuroendocrine features (AACR-IO 2026) - "M-ceNK are derived from an apheresis product (from healthy donors or cancer patients) and exposed to a cocktail of cytokines including N-803, IL-12, and IL-18 until a highly purified CD3 NEG CD56 HIGH cell population results. In: Proceedings of the AACR Immuno-Oncology Conference (AACR IO): Discovery and Innovation in Cancer Immunology: Revolutionizing Treatment through Immunotherapy; 2026 Feb 18-21; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Immunol Res 2026;14(2 Suppl):Abstract nr A018."

Clinical • IO biomarker • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Neoplasm • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • GZMB • IFNG • IL12A • IL15 • IL18 • KLRG1 • NCAM1 • TIGIT

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

Clinical • Oncology

M-ceNK Antitumor Activity in Neuroendocrine Tumors: NCI-Led Preclinical and In Vivo Efficacy Data (Businesswire) - "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....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, including five SCLC lines, four pulmonary carcinoid lines, and a large cell neuroendocrine carcinoma line, supporting the potential breadth of clinical applicability across neuroendocrine malignancies."

Preclinical • Large Cell Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Small Cell Lung Cancer

QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4

A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: ImmunityBio, Inc. | Initiation date: Mar 2025 ➔ Nov 2024

Platinum resistant • Trial initiation date • Oncology • Ovarian Cancer • Solid Tumor

QUILT 3.076 phase 1 study of memory-like cytokine-enriched natural killer (M-CENK) cells plus N-803 in locally advanced or metastatic solid tumors. (ASCO 2025) - P1 | "Preliminary efficacy objectives in cohort 2B are objective response rate (RECIST v1.1 and iRECIST criteria) and progression-free and overall survival evaluated using Kaplan-Meier methods. As of January 27, 2025, 15 participants have been enrolled in cohort 1, 21 participants in cohort 2 have undergone apheresis, and 10 participants have been treated with study therapies."

Metastases • P1 data • Immunology • Lung Cancer • Oncology • Solid Tumor • GZMB • IFNG • IL12A • IL15 • IL18

ImmunityBio Receives FDA Expanded Access Authorization for Landmark Treatment of Lymphopenia With ANKTIVA, the Cancer BioShield Platform, in Patients With Solid Tumors (Businesswire) - P2 | N=328 | QUILT-88 (NCT04390399) | Sponsor: ImmunityBio, Inc. | "ImmunityBio, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access authorization for the use of its Cancer BioShield platform, anchored by ANKTIVA (nogapendekin alfa inbakicept-pmln), to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first-line standard-of-care treatment, chemotherapy, radiation, or immunotherapy...At the 2025 ASCO Annual Meeting, ImmunityBio presented landmark results showing that reversing lymphopenia with ANKTIVA and CAR-NK therapy significantly prolonged median overall survival in third- to sixth-line metastatic pancreatic cancer patients. This benefit was further enhanced when treatment began at lower tumor burdens, as indicated by CA19-9 levels."

Commercial • P1 data • P2 data • Pancreatic Cancer • Solid Tumor

QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4

Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer. (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ImmunityBio, Inc. | Initiation date: Jan 2025 ➔ Jun 2025

Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Immunotherapy Before and After Surgery (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ImmunityBio, Inc. | Initiation date: Jan 2025 ➔ May 2025

Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 2, Open-label, Single-arm Study of Autologous M-CENK Adoptive Cell Therapy and N-803 (IL-15 Superagonist) in Combination with Gemcitabine in Participants with Recurrent Platinum-Resistant High-Grade Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: ImmunityBio, Inc. | Initiation date: Dec 2024 ➔ Mar 2025

Trial initiation date • Oncology • Ovarian Cancer • Solid Tumor

Open-Label, Phase 2 Clinical Trial of Pre-Radiation and Post-Radiation Immunotherapy with N 803, ETBX-071, and M-CENK in Combination with Radiation for Participants with High-Risk Prostate Cancer. (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ImmunityBio, Inc.

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Immunotherapy Before and After Surgery (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ImmunityBio, Inc.

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: ImmunityBio, Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Ovarian Cancer • Solid Tumor

A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ImmunityBio, Inc.

Combination therapy • New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Jun 2024 ➔ Mar 2025

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • NKG2D

First Data for ImmunityBio’s Memory Cytokine-Enriched NK Cells in Small Cell Lung Cancer at SITC Meeting Show Promising Anti-tumor Activity (Businesswire) - "ImmunityBio, Inc...today announced new data showing that the company’s Memory Cytokine-Enriched Natural Killer cells (M-ceNK) may provide benefit to patients with small cell lung cancer and patients with other types of neuroendocrine tumors....In the new study, the killing capacity of M-ceNK cells was assessed in four SCLC cell lines representing the major molecular subtypes. M-ceNK cells, generated from cells from several healthy donors, were found to express high levels of activating receptors and low levels of inhibitory receptors, as well as elevated IFN-γ and granzyme B production – all of which are important for anti-tumor activity....The M-ceNK cells were highly cytotoxic against all types of SCLC models, as well as against prostate neuroendocrine cancer."

Preclinical • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: ImmunityBio, Inc. | N=30 ➔ 50 | Trial completion date: Jun 2022 ➔ Dec 2024 | Trial primary completion date: Jun 2022 ➔ Jun 2024

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • NCAM1

Memory Cytokine-Enhanced Natural Killer Cells Show Promising Results in Leukemia Patients; Data Support ImmunityBio’s Scaled m-ceNK Clinical Program (Businesswire) - P2 | N=60 | NCT02782546 | "In a Phase 2 study sponsored by Washington University School of Medicine (NCT02782546), white blood cells retrieved from HCT donors to treat acute myeloid leukemia (AML) patients, were stimulated with cytokines (IL-12, -15, and -18) to form memory-like NK cells, and were re-infused to the patients, who also received ImmunityBio’s IL-15 superagonist Anktiva (N-803). The cytokine-stimulated NK cells safely augmented a leading treatment for AML-—HLA-haploidentical hematopoietic cell transplantation. The data showed that the cytokine-stimulated NK cells were persistent, showed increased production of interferon-gamma and functionality, and led to a complete response in 87% of patients after Day 28."

P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: ImmunityBio, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • NCAM1

QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: ImmunityBio, Inc.

Clinical • New P1 trial • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • NCAM1

FDA Authorizes ImmunityBio to Conduct a Trial of its First-in-Human, Cryopreserved, Memory Cytokine-Enriched NK Cell (m-ceNK) Platform in Solid Tumors (Businesswire) - "ImmunityBio, Inc...announced it has received FDA authorization to conduct a Phase 1 study to evaluate the safety and preliminary efficacy of its m-ceNK™ platform combined with its IL-15 superagonist Anktiva (N-803) in subjects with locally advanced or metastatic solid tumors....The study consists of two cohorts and there will be 10 participants in each cohort. Cohort 1 includes participants with newly diagnosed high-risk solid tumors who have not received prior treatment; and cohort 2 includes participants with relapsed/refractory (r/r) solid tumors who have progressive disease after receiving ≥ 2 prior therapies."

IND • Oncology • Solid Tumor