IVAC_M_uID / BioNTech - LARVOL DELTA

TNBC-MERIT: RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: BioNTech SE | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ May 2023

Trial completion • Trial 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 • PGR

[VIRTUAL] T-cell responses induced by an individualized neoantigen specific immune therapy in post (neo)adjuvant patients with triple negative breast cancer (ESMO 2020) - P1 | "In a third arm, patients were vaccinated with IVAC_M_uID, an on-demand manufactured Individualized NeoAntigen Specific Immunotherapy (iNeST) encoding neoepitopes derived from up to 20 cancer mutations determined by NGS...Funding: BioNTech SE. Clinical trial identification: NCT02316457."

Clinical • IO Biomarker • Tumor-specific neoantigens • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CCL3 • CD8 • IFNG • PD-1 • TNFA

[VIRTUAL] T-cell responses induced by an individualized neoantigen specific immune therapy in post (neo)adjuvant patients with triple negative breast cancer (CIMT 2021) - P1 | "In a third arm, patients were vaccinated with IVAC_M_uID, an on-demand manufactured Individualized NeoAntigen Specific Immunotherapy (iNeST) encoding neoepitopes derived from up to 20 cancer mutations determined by next generation sequencing (NGS)...Vaccine-induced CD8+ T cells were of effector/memory, PD1+ phenotype, with a high fraction IFNγ/TNFα/Mip-1a&b triple-positive. This first data suggests that the vaccine is highly efficient in inducing strong poly-epitopic T-cell responses in patients with TNBC in the post-(neo) adjuvant setting, justifying further trials to assess the efficacy of the vaccine in this patient population."

Clinical • IO biomarker • Tumor-specific neoantigens • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CCL3 • CD4 • CD8 • IFNG • PD-1 • TNFA

TNBC-MERIT: RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID (clinicaltrials.gov) - P1; N=42; Active, not recruiting; Sponsor: BioNTech SE; Trial completion date: Nov 2020 ➔ Dec 2023

Clinical • Trial 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 • PGR