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Table 2 Clinical Trials of mRNA Encoding TAAs

From: mRNA vaccine for cancer immunotherapy

Brand NCT Number Status Phases Disease Antigen mRNA Formulation Type Route Combo Sponsor (s) Study Results
CV9201 NCT00923312 Completed Phase 1/2 Stage IIIB/IV NSCLC MAGE-C1, MAGE-C2, NY-SEO-1, survivin, 5 T4 mRNA RNActive, (Protamine) i.d. NA CureVac CV9201 was well-tolerated and immune responses were detected after treatment. Median progression-free and overall survival were 5 and 10.8 months
CV9202 NCT03164772 Recruiting Phase 1/2 NSCLC NY-ESO-1, MAGE-C1, MAGE-C2, 5 T4, survivin, MUC1 mRNA RNActive, Protamine i.d. Durvalumab; Tremelimumab CureVac CV9202 was well-tolerated, and antigen specific immune responses were detected in majority of patients (84%)
CV9103 NCT00831467 Completed Phase I/2 Prostate cancer PSA, PSCA, PSMA, STEAP1 mRNA RNActive, Protamine i.d. NA CureVac CV9103 is well tolerated and immunogenic
CV9104 NCT01817738 Terminated Phase I/2 Prostate cancer PSA, PSCA, PSMA, STEAP1, PAP, MUC1 mRNA RNActive, Protamine i.d. NA CureVac Terminated due to insufficient activities
BNT111 (Lipo-MERIT) NCT02410733 Active,
not yet recruiting
Phase 1 advanced melanoma NY-ESO-1, MAGE-C3, tyrosinase,
gp100
mRNA Lipo-MERIT, DOTMA
(DOTAP)/
DOPE lipoplex
i.v. NA BioNTech Not available
IVAC NCT02316457 Active,
not yet recruiting
Phase 1 TNBC 3 TAAs selected mRNA Lipo-MERTI, DOTMA(DOTAP)/DOPE lipoplex i.v. NA BioNTech Not available
Not available NCT01995708 Active,
not yet recruiting
Phase 1 malignant melanoma CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells (LCs) dendritic cell (DC)-loaded mRNA CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells (LCs) i.d. NA Memorial Sloan Kettering Cancer Center Not available
Not available NCT00204516 Completed Phase 1/2 melanoma TAA for melanoma (Melan-A, Mage-A1, Mage-A3, survivin, GP100, and tyrosinase) naked mRNA naked mRNA i.d. GM-CSF The Norwegian Radium Hospital Not available
NA NCT01278940 Completed Phase 1/2 melanoma TAA-transfected DC dendritic cell (DC)-loaded mRNA DC loaded mRNA i.d. or i.n. IL-2 Oslo University Hospital Not available
AVX701 NCT01890213 Completed Phase 1 Stage III CRC an alphavirus replicon (VRP) encoding the protein (CEA) SAM VRP i.m. NA AlphaVax Not available
AVX701 NCT00529984 Completed Phase 1/2 Advanced or metastatic CEA expressing solid tumor an alphavirus replicon (VRP) encoding the protein (CEA) SAM VRP i.m. NA AlphaVax Five-year survival for patients with stage IV and stage III cancer was 17, 75%, respectively. All patients shown CEA-specific humoral immunity. CEA-specific, IFNγ-producing CD8 + granzyme B + TCM cells were increased.
So, VRP-CEA induces antigen-specific effector T cells while decreasing Tregs, suggesting favorable immune modulation.