m-ceNK cells / ImmunityBio - LARVOL DELTA

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