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

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