BI 1361849 / CureVac - LARVOL DELTA

A phase IB study of mRNA-based active cancer vaccine, BI1361849, combined with durvalumab and tremelimumab immunotherapy in patients with non-small cell lung cancer (NSCLC) (AACR 2024) - "In comparison to recent published studies treated with durvalumab and/or tremelimumab, incorporation of BI1361849 to durvalumab yielded comparable or better treatment response, PFS, and OS than durvalumab alone or with chemotherapy. However, tremelimumab did not add clinical benefit."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5 • CTAG1B • MAGEC1 • MUC1

Phase 1/2 study of mRNA vaccine therapy + durvalumab (durva) tremelimumab (treme) in patients with metastatic non-small cell lung cancer (NSCLC). (ASCO 2018) - P1/2; "The vaccine BI 1361849 (comprising 6 mRNAs encoding for selected tumor-associated antigens: MUC1, survivin, NY-ESO-1, 5T4, MAGE-C2 and MAGE-C1) is combined with 1 or 2 checkpoint inhibitors (durva [anti-PD-L1] treme [anti-CTLA-4]). Exploratory objectives include effects on tumor microenvironment and evaluation of immune responses. Enrollment opened 20Dec2017."

Clinical • P1/2 data • Non Small Cell Lung Cancer

Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC (clinicaltrials.gov) - P1/2; N=59; Completed; Sponsor: Ludwig Institute for Cancer Research; Active, not recruiting ➔ Completed; Trial completion date: Dec 2024 ➔ Oct 2021

Clinical • Trial completion • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

CureVac Announces Financial Results for the Second Quarter and First Half of 2021 and Provides Business Update (Issuer Direct) - "In June 2021, Boehringer Ingelheim expressed its intention to terminate the 2014 collaboration agreement on BI1361849. The termination will become effective in November 2021. The legacy program, targeting specific immune responses against tumor-associated antigens frequently overexpressed in patients with non-small cell lung cancer (NSCLC), applies an older protamine formulation technology, which reflected the state of the technology development at the time."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC (clinicaltrials.gov) - P1/2; N=56; Active, not recruiting; Sponsor: Ludwig Institute for Cancer Research; Recruiting ➔ Active, not recruiting; Trial primary completion date: Mar 2021 ➔ Oct 2021

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

Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC (clinicaltrials.gov) - P1/2; N=56; Recruiting; Sponsor: Ludwig Institute for Cancer Research; Not yet recruiting ➔ Recruiting; Initiation date: Jul 2017 ➔ Dec 2017; Trial primary completion date: Oct 2020 ➔ Mar 2021

Enrollment open • Trial initiation date • Trial primary completion date • Biosimilar • Non Small Cell Lung Cancer

Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer. (PubMed, J Immunother Cancer) - P1 | "The results support further investigation of mRNA-based immunotherapy in NSCLC including combinations with immune checkpoint inhibitors."

Clinical • IO Biomarker • Journal • P1 data