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Table 3 Clinical Trials of mRNA Vaccines Encoding Neoantigens (Neo-Ag)

From: mRNA vaccine for cancer immunotherapy

Brand NCT Number Status Phases Disease Antigen /mRNA Formulation Type Route Combinations Sponsor/Collaborators Study Results
IVAC MUTANOME, RBL001/RBL002 NCT02035956 Completed Phase 1 Advanced Melanoma Neo-Ag/TAA (mRNA) naked mRNA ultrasound- guided i.n. NA BioNTech 60% of the 125 selected neoepitopes elicited a T- cell response. The vaccination was very well tolerated.
RO7198457 NCT03289962 Recruiting Phase 1 Melanoma, NSCLC, Bladder Cancer,
CRC, Breast Cancer etc.
Neo-Ag (mRNA) Lipo-MERIT i.v. Atezolizumab (infusion) BioNTech, Genentech RO7198457 combined with atezolizumab was generally well tolerated; RO7198457 in combination with atezolizumab induced the release of pro-inflammatory cytokines and peripheral T-cell responses in the majority of patients
NCT04267237 Recruiting Phase 2 NSCLC Neo-Ag (mRNA) Lipo-MERIT i.v. Atezolizumab Hoffmann-La Roche NA
NCT03815058 Recruiting Phase 2 Advanced Melanoma Neo-Ag (mRNA) Lipo-MERIT i.v. Pembrolizumab (infusion) BioNTech, Genentech NA
NCT04486378 Recruiting Phase 2 Stage II and III CRC (surgically resected) Neo-Ag (mRNA) Lipo-MERIT i.v. NA BioNTech NA
NCT04161755 Recruiting Phase 1 Pancreatic Cancer (surgically resected) Neo-Ag (mRNA) Lipo-MERIT i.v. Atezolizumab, FOLIFIRINOX Memorial Sloan Kettering Cancer Center, Genentech NA
mRNA-4157 NCT03313778 Recruiting Phase 1 Mono-: resected solid tumors; Combo: unresectable solid tumor Neo-Ag (mRNA) LNP i.m. Pembrolizumab (infusion) Moderna, Merck mRNA-4157 is safe and well tolerated at all tested dose levels. Clinical responses were observed when dosing combined with Pembrolizumab. Neoantigen-specific T cells have been detected
NCT03897881 Recruiting Phase 2 Complete Resection of High-Risk Melanoma Neo-Ag (mRNA) LNP i.m. Pembrolizumab (infusion) Moderna, Merck Not available
mRNA-5671/Merck V941 NCT03948763 Recruiting Phase 1 CRC, NSCLC, pancreatic cancer KRAS mutations: G12D, G12V, G13D, G12C (mRNA) LNP i.m. Pembrolizumab (infusion) Moderna, Merck Not available
Not available NCT03468244 Recruiting Phase 1 Advanced Esophageal Squamous Carcinoma; Gastric Adenocarcinoma; Pancreatic Adenocarcinoma; Colorectal Adenocarcinoma Neo-Ag (mRNA) lipopolyplex s.c. NA Changhai Hospital, Stemirna Therapeutics Not available