BN-Brachyury / Bavarian Nordic - LARVOL DELTA

Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury-TRICOM vaccine in patients with advanced cancer. (PubMed, J Immunother Cancer) - P1 | "Intravenous administration of MVA-BN-brachyury-TRICOM vaccine was safe and tolerable. Maximum tolerated dose was not reached. The maximum administered dose was 10 infectious units every 3 weeks for three doses. This dose was selected as the recommended phase 2 dose."

Clinical • Journal • P1 data • Chordoma • Hypotension • Infectious Disease • Inflammation • Oncology • Pain • Respiratory Diseases • Sarcoma • Solid Tumor • CD8

BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) (clinicaltrials.gov) - P1b; N=1; Completed; Sponsor: National Cancer Institute (NCI); Suspended ➔ Completed; N=65 ➔ 1; Trial completion date: Jan 2024 ➔ Oct 2021; Trial primary completion date: Jan 2024 ➔ Oct 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • ER • HER-2 • PD-L1 • PGR

BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) (clinicaltrials.gov) - P1b; N=65; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended

Trial suspension • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • ER • HER-2 • PD-L1 • PGR

BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) (clinicaltrials.gov) - P1b; N=65; Recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Jan 2022 ➔ Jan 2024; Trial primary completion date: Jan 2022 ➔ Jan 2024

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • ER • HER-2 • PD-L1 • PGR

BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) (clinicaltrials.gov) - P1b; N=55; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • ER • HER-2 • PD-L1 • PGR

BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) (clinicaltrials.gov) - P1b; N=65; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • ER • HER-2 • PD-L1 • PGR

Bavarian Nordic Announces Top-line Results from Phase 2 Clinical Trial of BN-Brachyury in Chordoma (GlobeNewswire) - P2, N=29; NCT03595228; Sponsor: Bavarian Nordic; "Bavarian Nordic A/S...announced top-line results from a Phase 2 clinical study evaluating the targeted immunotherapy candidate, BN-Brachyury in the treatment of advanced chordoma, a rare cancer occurring in the base of the skull and spine. While the study failed to meet its primary endpoint, it provided evidence of clinical activity....Two patients achieving objective responses were observed in the study, as measured by the predefined conventional assessment criteria (RECIST) according to the study protocol. In addition, 19 patients have stable disease, while the rest progressed, or left the study before the assessment was performed. The RECIST criteria assumes tumors are spherical and assesses their size by measuring the tumor diameter."

P2 data • Chordoma • Oncology

EMD Serono Advances Oncology Portfolio and Pipeline with New and Long-term Data in Multiple Cancers at ESMO 2020 (EMD Serono Press Release) - "Two long-term follow-up studies assessing efficacy and safety from the INTR@PID clinical trial program will be presented as posters at ESMO 2020...In addition, preliminary analysis will be presented in a mini-oral presentation (#616MO) from a trial conducted by the National Cancer Institute (NCI), the Quick Efficacy Seeking Trial (QuEST), investigating a triple combination therapy (BN-brachyury [BVax] + bintrasfusp alfa + N-803) in castration-resistant prostate cancer."

Clinical data • Biliary Tract Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer

Bavarian Nordic completes enrollment of phase 2 trial in chordoma patients (Bavarian Nordic Press Release) - “Bavarian Nordic A/S…announced today the completion of enrollment of the Phase 2 trial investigating the novel targeted cancer immunotherapy candidate BN-Brachyury, in the treatment of advanced chordoma….A total of 29 patients have been enrolled, 19 of which were enrolled in the second stage of the trial.”

Enrollment closed

Bavarian Nordic completes enrollment of first stage in chordoma phase 2 trial (GlobeNewswire) - "Bavarian Nordic A/S...announced...that the first stage of a Phase 2 study of its novel, targeted cancer immunotherapy candidate, BN-Brachyury in the treatment of advanced chordoma has completed recruitment of the planned 10 patients ahead of schedule....First results from this stage are expected to become available in the second half of 2019."

Enrollment status • P2 data