ETBX-061 / ImmunityBio - LARVOL DELTA

Tri-Ad5 vaccine plus bintrafusp alfa for newly diagnosed, advanced-stage head and neck cancer not associated with human papillomavirus infection. (PubMed, Oncologist) - P1/2 | "In this small study, Tri-Ad5 vaccine plus bintrafusp alfa resulted in CPD in 2/6 patients. Participants also had favorable 2-year RFS compared to historical values. Ongoing tissue and peripheral immunome analyses may provide mechanistic insight. (ClincalTrials.gov Identifier: NCT04247282; IRB Approved.)."

Journal • Head and Neck Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CEACAM5 • MUC1

QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma. (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: ImmunityBio, Inc. | Phase classification: P1b/2 ➔ P1/2

Phase classification • Chordoma • Oncology • Solid Tumor

Case report: PD-L1-targeted high-affinity natural killer cells and IL-15 superagonist N-803-based therapy extend overall survival of advanced metastatic pancreatic cancer patients. (PubMed, Front Oncol) - "From late 2019 to 2021, single-patient Investigational New Drug (spIND) protocols for five mPC patients were designed and approved that generally comprised combined Abraxane (nab-paclitaxel) and gemcitabine therapy with experimental therapeutics N-803, PD-L1-targeted high-affinity natural killer (PD-L1 t-haNK) cells, and aldoxorubicin, a serum albumin-binding doxorubicin prodrug. Some patients also received stereotactic body radiation therapy (SBRT), cyclophosphamide, pembrolizumab, nivolumab, and/or experimental ETBX-051 (brachyury) and/or ETBX-061 (MUC1) vaccines...The OS of 13, 26.9, and 23.2 months for three patients is particularly notable. The findings here support the ongoing clinical investigations of N-803 and PD-L1 t-haNK cells in combination therapy."

Journal • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9 • MUC1 • PD-L1

QUILT-3.071: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (clinicaltrials.gov) - P1/2 | N=2 | Terminated | Sponsor: ImmunityBio, Inc. | Phase classification: P1b/2 ➔ P1/2 | N=332 ➔ 2 | Active, not recruiting ➔ Terminated; low enrollment

Enrollment change • Metastases • Phase classification • Trial termination • Colorectal Cancer • Oncology • Solid Tumor

QUILT-3.080: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov) - P1/2 | N=3 | Terminated | Sponsor: ImmunityBio, Inc. | Phase classification: P1b/2 ➔ P1/2 | N=173 ➔ 3 | Unknown status ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention

Enrollment change • Phase classification • Trial termination • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (clinicaltrials.gov) - P1/2 | N=4 | Terminated | Sponsor: ImmunityBio, Inc. | N=65 ➔ 4 | Unknown status ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention

Enrollment change • Trial termination • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. (clinicaltrials.gov) - P1/2 | N=9 | Terminated | Sponsor: ImmunityBio, Inc. | N=79 ➔ 9 | Trial completion date: Oct 2023 ➔ Jan 2024 | Active, not recruiting ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention

Enrollment change • Trial completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. (clinicaltrials.gov) - P1/2 | N=79 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: Jan 2023 ➔ Oct 2023 | Trial primary completion date: Dec 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. (clinicaltrials.gov) - P1/2 | N=79 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: Jan 2020 ➔ Jan 2023 | Trial primary completion date: Dec 2019 ➔ Dec 2022

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

QUILT-3.071: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (clinicaltrials.gov) - P1b/2 | N=332 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (clinicaltrials.gov) - P1b/2; N=332; Active, not recruiting; Sponsor: NantKwest, Inc.; Trial primary completion date: Dec 2019 ➔ Dec 2021

Clinical • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Treatment of Castration Resistant Prostate Cancer Using Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: National Cancer Institute (NCI); Active, not recruiting ➔ Completed; Trial completion date: Jan 2025 ➔ Mar 2021

Clinical • Trial completion • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ImmunityBio Announces 12-Month Overall Survival Probability of 83% in NCI-Led Phase 1 Study of Multi-Targeted hAd5 Immunotherapy Vaccine in Patients with Advanced Metastatic Prostate Cancer (Businesswire) - P1, N=18; NCT03481816; "ImmunityBio...today announced the publication of Phase I data in The Journal of ImmunoTherapy of Cancer (JITC). The publication, titled 'Phase I study of a multitargeted recombinant Ad5 PSA/MUC-1/ brachyury-based immunotherapy vaccine in patients with metastatic castration-resistant prostate cancer (mCRPC)' highlighted the safety, T-cell immunogenicity, and clinical activity of ImmunityBio’s second-generation human adenovirus (hAd5) in patients with incurable mCRPC...Study Highlights...Median progression-free survival (PFS) was 22 weeks (95% confidence interval: 19.1 to 34). Median overall survival (OS) was not reached, and the 12-month OS probability for all patients was 83.3% (95% confidence interval: 56.8% to 94.3%)."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer

QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (clinicaltrials.gov) - P1/2; N=65; Active, not recruiting; Sponsor: NantKwest, Inc.; Trial completion date: Dec 2019 ➔ Apr 2021; Trial primary completion date: Dec 2019 ➔ Jan 2021

Clinical • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Molecularly Informed Integrated Immunotherapy Combining Innate haNK Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti- PD-1/ PD-L1 Therapy (clinicaltrials.gov) - P1/2; N=65; Recruiting; Sponsor: NantKwest, Inc.

Clinical • New P1/2 trial • Biosimilar • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Multi-Targeted Recombinant Ad5 (CEA/MUC1/Brachyury) Based Immunotherapy Vaccine Regimen in People With Advanced Cancer (clinicaltrials.gov) - P1; N=11; Completed; Sponsor: National Cancer Institute (NCI); Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

Treatment of Castration Resistant Prostate Cancer Using Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: May 2020 ➔ Jan 2025; Trial primary completion date: May 2020 ➔ Jan 2020

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Treatment of Castration Resistant Prostate Cancer Using Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Jun 2021 ➔ May 2020; Trial primary completion date: May 2021 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date

Treatment of Castration Resistant Prostate Cancer Using Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines (clinicaltrials.gov) - P1; N=5; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Active, not recruiting

Clinical • Enrollment closed

QUILT-3.052: NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: NantKwest, Inc.; N=67 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • CCNB1

QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: NantKwest, Inc.; N=113 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • CCNB1

QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: NantKwest, Inc.; N=67 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • CCNB1

QUILT-3.049: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Combination Immunotherapy in Subjects With TNBC Who Have Progressed on or After Anthracycline-based Chemotherapy (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: NantKwest, Inc.; N=79 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • CCNB1

QUILT-3.088: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: NantKwest, Inc.; N=1064 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • CCNB1

QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: NantKwest, Inc.; N=113 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • CCNB1