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