EP-101 STEMVAC / EpiThany, University of Washington - LARVOL DELTA

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: University of Washington | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Nov 2032 | Trial primary completion date: Aug 2024 ➔ Nov 2027

Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ENG

A Vaccine (STEMVAC) for Improving Survival in Patients With Triple-Negative Breast Cancer and Moderate or Extensive Residual Cancer Burden (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: University of Washington

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A phase II study of the DNA plasmid-based vaccine STEMVAC in patients with metastatic triple-negative breast cancer (mTNBC). (ASCO 2026) - P2 | "This trial aims to evaluate whether STEMVAC would achieve clinically relevant immunogenicity when administered concurrently with chemotherapy for the treatment of mTNBC. The trial will evaluate the safety and preliminary efficacy of this novel combination and explore tumor-immune microenvironment biomarkers to gain mechanistic insight."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • Hematological Malignancies • Immunology • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • CDH3 • CSF2 • ENG • IFNG • PD-L1 • SOCS1 • SOX2

A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: University of Washington | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ENG • ER • HER-2 • PD-L1 • PGR

Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: University of Washington | Trial completion date: Feb 2027 ➔ Sep 2026

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

A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: University of Washington | Initiation date: Dec 2025 ➔ Mar 2026

Trial initiation date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ENG

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: University of Washington | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Jul 2028 | Trial primary completion date: Dec 2025 ➔ Jul 2026

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

A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: University of Washington | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=5 | Active, not recruiting | Sponsor: University of Washington | N=40 ➔ 5

Enrollment change • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ENG

A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: University of Washington

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: University of Washington

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ENG

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: University of Washington | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ENG

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: University of Washington | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Apr 2025 ➔ Dec 2025

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

The potential of ARL4C and its-mediated genes in atherosclerosis and agent development. (PubMed, Front Pharmacol) - "Many agents, including ABCA1 agonists (CS-6253, IMM-H007, RG7273, and R3R-01), FLNA antagonist sumifilam, LRP6 inhibitor BI-905677 and agonist SZN-1326, and SOX2 inhibitor STEMVAC, were investigated in clinical trials. Thus, ARL4C and its regulated genes may be a potential target for drug development. Thus, we focus on the role of ARL4C and its-mediated genes in atherosclerosis and agent development, which provide insights for the identification, research, and drug development of novel targets."

Journal • Review • Atherosclerosis • Cardiovascular • Colorectal Cancer • Hepatology • Liver Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ABCA1 • ALDH1A3 • SNAI2 • SOX2

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: University of Washington | Trial completion date: Apr 2024 ➔ Dec 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

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

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: University of Washington | Trial completion date: Jan 2026 ➔ Dec 2026 | Trial primary completion date: Jan 2024 ➔ Dec 2025

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4

Optimizing immunization schedules for therapeutic vaccination (SITC 2022) - P1 | "We evaluated immunization schedules with a 5-antigen, multi-epitope plasmid DNA vaccine, STEMVAC, targeting cancer stem cell associated proteins...Conclusions Varying the time between immunizations can significantly impact the quality of the T-cell response to a mulit-antigen plasmid-based vaccine. Further studies are ongoing to correlate these differences to anti-tumor activity."

Breast Cancer • Oncology • Solid Tumor • CSF2 • IFNG

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: University of Washington | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CDH3 • ENG • IFNG • SOX2 • TRB

A Phase I dose escalation study of STEMVAC, a multi-antigen, multi-epitope Th1 selective plasmid-based vaccine, targeting stem cell associated proteins in patients with advanced breast cancer (SITC 2022) - P2 | "Conclusions STEMVAC selectively elicits high level persistent Type I T-cell responses at the 300mcg dose. Two Phase II studies are enrolling; adjuvant setting for TNBC ( NCT05455658 ) and maintenance therapy with pembrolizumab in metastatic non-small cell lung cancer ( NCT05242965 )."

Clinical • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CDH3 • CSF2 • ENG • HER-2 • IFNG • IL10 • SOX2

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: University of Washington | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD69 • CD8 • ER • FOXP3 • GATA3 • HER-2 • IFNG • LAG3 • PGR • TNFRSF9 • TRB

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: University of Washington

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD44 • CD69 • CD8 • ER • FOXP3 • GATA3 • HER-2 • IFNG • LAG3 • PGR • TNFRSF9 • TRB