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mRNA cancer vaccine

Self-adjuvanting mRNA-based immunotherapeutic cancer vaccine


BI 1361849* (CV9202) is an mRNA-based immunotherapeutic cancer vaccine (ICV) that has the potential to mobilise the patient’s immune system to fight tumours. It is currently being investigated in non-small cell lung cancer (NSCLC) following promising preclinical results.1

About BI 1361849

BI 1361849’s mechanism of action

BI 1361849 (CV9202) is an 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 poor survival outcomes3,6
  4. TPBG (5T4) – expressed on tumour-initiating cells and associated with poor survival 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
Enhanced expression and adjuvanticity with RNActivetechnology

The mechanism of action of BI 1361849 is thought to be as follows:2

  1. Intradermal administration of ICVs
  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. BI 1361849 encodes six different target antigens
  3. Activation of the innate, antigen-independent immune system. Due to the self-adjuvanting properties of RNActive® vaccines resulting from activation of pattern recognition receptors such as toll-like receptor (TLR) 7/8, no further added adjuvant is needed
  4. Expansion of antigen-specific T- and B-cells. Antigen presentation in draining lymph nodes results in stimulation of the adaptive, antigen-specific immune system
  5. The overall result is a balanced humoral and T-cell-mediated 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
BI 1361849mechanism of action

Clinical development: NSCLC

A Phase I/IIa trial, CV9201-003, with a BI 1361849 predecessor demonstrated that antigen-specific responses occurred in 65% of patients receiving CV9201; cellular and humoral immune responses were detected in 39% and 49% of these patients, respectively.11 In a Phase Ib study, CV9202-006, immune responses against multiple antigens were detected in 52% of all evaluable patients,12 and the safety profile and dosing schedule of BI 1361849 was confirmed.13


Future trials are being planned to investigate BI 1361849 in combination with other immunotherapies.

mRNA ICV trial table

AE, adverse event; DLT, dose-limiting toxicity; HRQoL, health-related quality of life; OS, overall survival; PFS, progression-free survival, PSA, prostate-specific antigen; TTP, time to progression.

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CureVac AG. RNActive® cancer immunotherapies and prophylactic vaccine. (Accessed: July 2017).


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


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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.


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


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


Papachristofilou A, et al. J Thorac Oncol 2017;12(1 Suppl):S1333–S4.

14 NCT00923312. (Accessed: July 2017).

15 NCT01915524. (Accessed July 2017).

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