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mRNA-based cancer vaccine (BI 1361849)

BI 1361849: a self-adjuvanting mRNA-based immunotherapeutic cancer vaccine


BI 1361849* (CV9202) is a messenger RNA- (mRNA-) based immunotherapeutic cancer vaccine (ICV) that has the potential to mobilise the patient’s immune system to fight tumours.

Clinical trials: BI 1361849 is currently being investigated in non-small cell lung cancer (NSCLC) following promising preclinical results.1

About BI 1361849

Tumour associated antigens

BI 1361849 (CV9202) is a mRNA-based ICV created using RNActive® (CureVac AG, Germany) technology, which utilises optimised mRNA sequences to increase antigen expression.2,3 BI 1361849 consists of six mRNAs that code for six different antigens that are frequently expressed in NSCLC:

  1. NY-ESO-1 – expression is associated with poor survival outcomes in NSCLC patients3,4
  2. MAGE C1 – highly expressed by a number of tumours including NSCLC; co-expression with NY-ESO-1 has also been observed in several cancer cell lines and primary tumours3,5
  3. MAGE C2 – often expressed in tumours such as NSCLC and associated with poorer survival outcomes3,6
  4. TPBG (5T4) – expressed on tumour-initiating cells and associated with poorer clinical outcomes in NSCLC7
  5. Survivin – overexpressed in the majority of tumours including NSCLC, and associated with tumour proliferation and poor survival outcomes8
  6. MUC1 – overexpressed and under-glycosylated in nearly all epithelial cells of adenocarcinoma histology, including those from the lung9

Vaccines created using RNActive® technology have two components:

  1. Free mRNA that is engineered to improve stability without changing the amino acid sequence of the corresponding protein
  2. mRNA complexed with protamine to increase immunogenicity2,3,10

Modification of RNA to enhance antigen expression and adjuvanticity

Enhanced expression and adjuvanticity with RNActivetechnology

Mechanism of action

BI 1361849 aims to induce a tumour-specific immune response via the following hypothesised steps:2,3,11

  1. Administration: intracutaneous administration of ICV
  2. Translation of encoded proteins: ICVs are taken up by the cells of the dermis, including antigen-presenting dendritic cells, and corresponding proteins are translated intracellularly
  3. Activation of the adaptive immune system: antigen presentation in draining lymph nodes results in stimulation of the adaptive, antigen-specific immune system leading to expansion of antigen-specific T and B cells. Due to the self-adjuvanting properties of RNActive® vaccine, no additional adjuvant is required
  4. Balanced humoral and T cell-mediated immune response: the overall effect is a balanced cellular and humoral immune response with an acute effect (involving cytotoxic T cells and helper T cells) and a long-term effect (involving memory T cells and antibody-producing B-lymphocytes)

mRNA-based immunotherapeutic cancer vaccine mechanism of action2,3,11

BI 1361849mechanism of action

Clinical development

In a Phase I/IIa trial involving patients with Stage IIIB/IV NSCLC, a predecessor to BI 1361849 (CV9201-003; which coded for MAGE-C1, MAGE-C2, NY-ESO-1, BIRC5, 5T4) induced antigen-specific immune responses against at least 1 antigen in 65% of patients. Cellular and humoral immune responses were detected in 39% and 49% of these patients, respectively.12

In a more recent Phase Ib study of BI 1361849 (CV9202) in patients with Stage IV NSCLC, cellular and humoral immune responses were observed in the majority of patients. Over half (52%) of evaluable patients had stable disease.1,13

The combination of BI 1361849 plus durvalumab is currently being investigated with/without tremelimumab in a Phase I/II trial in metastatic NSCLC patients (NCT03164772).14 Future trials are being planned to investigate BI 1361849 in combination with other immunotherapies.

Advanced NSCLC

Clinical trial of an mRNA-based immunotherapeutic cancer vaccine in patients with advanced NSCLC

AE, adverse event; DoR, duration of response; ICV, immunotherapeutic cancer vaccine; mRNA, messenger ribonucleic acid; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.

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Hipp MM, et al. Cancer Immunol Res 2016;4(Suppl. 11):B072


CureVac AG. RNActive® cancer immunotherapies and prophylactic vaccine. (Accessed: November 2019).


Sebastian M, et al. BMC Cancer 2014;14:748.


Kim SH, et al. Lung 2009;187(6):401–11.


Cho HJ, et al. Cancer Immun 2006;6:12.


Chen X, et al. Oncol Lett 2017;13(3):1609–18.


Damelin M, et al. Cancer Res 2011;71(12):4236–46.


Zhang LQ, et al. PLoS ONE 2012;7(3):e34100.


Singh R, Bandyopadhyay D. Cancer Biol Ther 2007;6(4):481–6.


Kallen KJ, et al. Hum Vaccin Immunother 2013;9(10):2263–76.


Kowalczyk A, et al. Vaccine 2016;34(33):3882–93.


Sebastian M, et al. J Clin Oncol 2012;30(Suppl. 15):2573.


Papachristofilou A, et al. J Thorac Oncol 2017;12(Suppl. 1):S1333–S1334.

14 NCT03164772. (Accessed: November 2019).

*This is an investigational compound and has not been approved. Its safety and efficacy have not been established.


© 2019 Boehringer Ingelheim International GmbH. All rights reserved.


Page last updated: November 2019