neoantigen DNA vaccine / Washington University School of Medicine in St. Louis, AstraZeneca - LARVOL DELTA

Personalized Neoantigen Vaccine in Combination With Durvalumab (MEDI4736) in Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=6 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial primary completion date: Mar 2028 ➔ Sep 2027 | Recruiting ➔ Active, not recruiting | N=20 ➔ 6 | Trial completion date: Mar 2030 ➔ Sep 2029

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Oct 2027 ➔ Oct 2028 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1 • IDH2 • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1 • IDH2 • MGMT

New vaccine shows potential in preventing recurrence of triple-negative breast cancer (News-Medical) - P1 | N=18 | NCT02348320 | "A small clinical trial shows promising results for patients with triple-negative breast cancer who received an investigational vaccine designed to prevent recurrence of tumors...The phase I clinical trial -; conducted at Siteman Cancer Center, based at Barnes-Jewish Hospital and WashU Medicine -; involved 18 patients diagnosed with triple-negative breast cancer that was not metastatic, meaning it had not spread to other organs...Following treatment, 14 of 18 patients showed immune responses to the vaccine and, after three years, 16 patients remained cancer-free. While the early-stage trial was designed to evaluate safety of the vaccine and did not include a control group to determine efficacy, the researchers analyzed historical data from patients with triple-negative breast cancer treated with the standard of care only. In that group, on average, about half of patients remained cancer-free at three years post-treatment."

P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Neoantigen DNA vaccines are safe, feasible, and induce neoantigen-specific immune responses in triple-negative breast cancer patients. (PubMed, Genome Med) - P1 | "Our study demonstrates neoantigen DNA vaccines are safe, feasible, and capable of inducing neoantigen-specific immune responses."

Journal • Tumor-specific neoantigens • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors (clinicaltrials.gov) - P1 | N=7 | Recruiting | Sponsor: Washington University School of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Oncology • Pediatrics • Solid Tumor

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors (clinicaltrials.gov) - P1 | N=7 | Not yet recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Sep 2030 ➔ Dec 2030 | Trial primary completion date: Oct 2028 ➔ Jan 2029

Trial completion date • Trial primary completion date • Brain Cancer • Oncology • Pediatrics • Solid Tumor

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1 • IDH2 • MGMT

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors (clinicaltrials.gov) - P1 | N=7 | Not yet recruiting | Sponsor: Washington University School of Medicine | N=10 ➔ 7

Enrollment change • Brain Cancer • Oncology • Pediatrics • Solid Tumor

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Jul 2028 ➔ Sep 2030 | Trial primary completion date: Aug 2026 ➔ Oct 2028

Trial completion date • Trial primary completion date • Brain Cancer • Oncology • Pediatrics • Solid Tumor

Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy (clinicaltrials.gov) - P1 | N=18 | Terminated | Sponsor: Washington University School of Medicine | Trial completion date: Aug 2023 ➔ May 2023 | Active, not recruiting ➔ Terminated; Drugs/equipment unavailable and insufficient funding

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

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Apr 2028 ➔ Jul 2028 | Trial primary completion date: May 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Brain Cancer • Oncology • Pediatrics • Solid Tumor

Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Washington University School of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Jun 2027 ➔ Oct 2027 | Initiation date: Jun 2023 ➔ Oct 2023 | Trial primary completion date: Sep 2024 ➔ Jan 2025

Trial completion date • Trial initiation date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

Personalized Neoantigen Vaccine in Combination With Durvalumab (MEDI4736) in Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=27 | Recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Jun 2026 ➔ Mar 2030 | Trial primary completion date: Jun 2024 ➔ Mar 2028

Trial completion date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Apr 2023 ➔ Dec 2023

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

A pilot trial of neoantigen DNA vaccine in combination with nivolumab/ipilimumab and prostvac in metastatic hormone-sensitive prostate cancer (mHSPC). (ASCO 2022) - P1 | "Eligible patients had histologically confirmed high risk mHSPC, must have completed a course of docetaxel and received continuous androgen deprivation therapy. This is the first clinical trial evaluating the use of personalized neoantigen vaccines in a combination immunotherapeutic approach in mHSPC patients."

Combination therapy • IO biomarker • Tumor-specific neoantigens • Fatigue • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Prostate Cancer • Solid Tumor • TMB

Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Feb 2023 ➔ Aug 2023

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

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Jul 2027 ➔ Dec 2027 | Trial primary completion date: Aug 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Brain Cancer • Oncology • Pediatrics • Solid Tumor

Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Washington University School of Medicine

New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Immune Modulation • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Aug 2023 ➔ Feb 2023

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

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Washington University School of Medicine | Trial completion date: May 2025 ➔ Jul 2027 | Trial primary completion date: May 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Brain Cancer • Oncology • Pediatrics • Solid Tumor

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2024 ➔ Apr 2023 | Trial primary completion date: Dec 2023 ➔ May 2022

Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy (clinicaltrials.gov) - P1 | N=15 | Terminated | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Terminated; Loss of funding

Trial termination • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2023 ➔ Aug 2023

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