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:
Vaccines created using RNActive® technology have two components:
Modification of RNA to enhance antigen expression and adjuvanticity
Mechanism of action
BI 1361849 aims to induce a tumour-specific immune response via the following hypothesised steps:2,3,11
mRNA-based immunotherapeutic cancer vaccine mechanism of action2,3,11
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.
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.
Hipp MM, et al. Cancer Immunol Res 2016;4(Suppl. 11):B072
CureVac AG. RNActive® cancer immunotherapies and prophylactic vaccine. http://www.curevac.com/rna-platform/rnactiver/ (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.
ClinicalTrials.gov. NCT03164772. https://clinicaltrials.gov/ct2/show/NCT03164772 (Accessed: November 2019).
*This is an investigational compound and has not been approved. Its safety and efficacy have not been established.
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Page last updated: November 2019
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