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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:
Vaccines created using RNActive® technology have two components:
The mechanism of action of BI 1361849 is thought to be as follows:2
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.
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.
Kowalczyk A, et al. Vaccine 2016;34(33):3882-93.
CureVac AG. RNActive® cancer immunotherapies and prophylactic vaccine. http://www.curevac.com/rna-platform/rnactiver/ (Accessed: July 2017).
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.
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.
ClinicalTrials.gov. NCT00923312. https://clinicaltrials.gov/ct2/show/NCT00923312 (Accessed: July 2017).
ClinicalTrials.gov. NCT01915524. https://clinicaltrials.gov/ct2/show/NCT01915524 (Accessed July 2017).
*This is an investigational compound and has not been approved. Its safety and efficacy have not been established.
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