Product Description
mRNA-4157 is an mRNA-based individualized, therapeutic personalized cancer vaccine (PCV) targeting twenty tumor-associated antigens (TAAs) that are specifically expressed by the patient's cancer cells, with potential immunostimulatory and antineoplastic activities. The cells from the patient's tumor are analyzed, and genetic sequencing is used to identify twenty neoantigen epitopes that may elicit the strongest immune response in the patient. The sequences encoding the twenty patient-specific epitopes are transcribed and loaded onto a single mRNA molecule. Upon administration, the mRNA-based PCV mRNA-4157 is taken up and translated by antigen presenting cells (APCs). Then, the expressed epitopes are presented via major histocompatibility complex (MHC) molecules on the surface of the APCs. This leads to an induction of both cytotoxic T-lymphocyte (CTL)- and memory T-cell-dependent immune responses that specifically target and destroy the patient's cancer cells that express these neoantigens. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mrna-based-personalized-cancer-vaccine-mrna-4157)
Mechanisms of Action: Vaccine
Novel Mechanism: No
Modality: Nucleic Acid
Route of Administration: Intramuscular
FDA Designation: Breakthrough Therapy - Melanoma *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Merck
Company Location: Eastern America
Company Founding Year: 1668
Additional Commercial Interests: Moderna
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 22
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Moderna announced they will present P3 Melanoma results in 2H26 for Intismeran autogene
- Clinical Outcomes Reported - Merck presented P2 Melanoma results on 2026-06-01 for Intismeran autogene
- Clinical Outcomes Reported - Merck presented P2 Melanoma results on 2026-05-29 for Intismeran autogene
Highest Development Phases
Phase 3: Lewy Body Disease|Melanoma|Non-Small-Cell Lung Cancer|Parkinson's Disease|Skin Cancer|Small Cell Lung Cancer
Phase 2: Bladder Cancer|Carcinoma in Situ|Renal Cell Carcinoma|Transitional Cell Carcinoma
Phase 1: Adenocarcinoma|Cutaneous Squamous Cell Carcinoma|Esophageal Cancer|Gastrointestinal Cancer|Pancreatic Cancer|Pancreatic Ductal Carcinoma|Squamous Cell Carcinoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06307431 |
INTerpath-004 | P2 |
Active, not recruiting |
Renal Cell Carcinoma |
2028-01-08 |
68% |
2025-05-14 |
Primary Endpoints|Treatments|Trial Status |
2023-505712-37-00 |
V940-007 | P3 |
Active, not recruiting |
Skin Cancer |
2033-05-06 |
3% |
2025-05-02 |
Treatments |
NCT06305767 |
INTerpath-005 | P2 |
Active, not recruiting |
Parkinson's Disease|Bladder Cancer|Lewy Body Disease |
2027-04-23 |
12% |
2026-01-14 |
|
2023-505658-17-00 |
V940-005 | P2 |
Recruiting |
Transitional Cell Carcinoma |
2032-05-17 |
12% |
2025-05-02 |
Treatments |
NCT06833073 |
INTerpath-011 | P2 |
Recruiting |
Bladder Cancer|Carcinoma in Situ |
2031-09-03 |
51% |
2025-05-10 |
|
NCT03313778 |
KEYNOTE-603 | P1 |
Active, not recruiting |
Pancreatic Ductal Carcinoma|Small Cell Lung Cancer|Gastrointestinal Cancer|Pancreatic Cancer|Adenocarcinoma|Esophageal Cancer|Squamous Cell Carcinoma|Cutaneous Squamous Cell Carcinoma|Melanoma|Non-Small-Cell Lung Cancer |
2027-11-21 |
50% |
2026-03-05 |
|
2024-519605-36-00 |
V940-012 | P2 |
Not yet recruiting |
Melanoma |
2028-06-12 |
|||
2023-505177-32-00 |
V940-004 | P2 |
Recruiting |
Renal Cell Carcinoma |
2027-05-17 |
68% |
2025-05-02 |
Treatments |
2025-522643-18-00 |
V940-014 | P3 |
Not yet recruiting |
Small Cell Lung Cancer|Non-Small-Cell Lung Cancer |
2038-05-11 |
89% |
||
jRCT2021260028 |
jRCT2021260028 | P3 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2038-05-11 |
89% |
||
2023-506327-29-00 |
V940-009 | P3 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2038-01-26 |
88% |
2025-05-02 |
Treatments |
2023-504923-20-00 |
V940-002 | P3 |
Recruiting |
Non-Small-Cell Lung Cancer |
2035-12-21 |
52% |
2025-05-02 |
Treatments |
NCT07513376 |
INTerpath-014 | P3 |
Recruiting |
Non-Small-Cell Lung Cancer |
2034-08-22 |
89% |
2026-08-22 |
Primary Endpoints|Treatments |
NCT06623422 |
INTerpath-009 | P3 |
Recruiting |
Parkinson's Disease|Lewy Body Disease|Non-Small-Cell Lung Cancer |
2033-05-16 |
88% |
2026-04-01 |
Primary Endpoints |
2023-503652-27-00 |
V940-001 | P3 |
Active, not recruiting |
Melanoma |
2030-09-26 |
2025-05-02 |
Treatments |
|
NCT06077760 |
INTerpath-002 | P3 |
Recruiting |
Non-Small-Cell Lung Cancer |
2030-06-25 |
88% |
2025-05-14 |
Primary Endpoints|Treatments |
NCT05933577 |
V940-001 | P3 |
Active, not recruiting |
Melanoma |
2029-10-26 |
2025-05-14 |
Primary Endpoints|Treatments |
|
NCT03897881 |
KEYNOTE-942 | P2 |
Active, not recruiting |
Melanoma |
2032-11-30 |
2025-12-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
2024-517335-46-00 |
V940-011 | P2 |
Not yet recruiting |
Bladder Cancer |
2031-08-12 |
51% |
2025-04-30 |
Treatments |
2025-520902-37-00 |
V940-013 | P2 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2031-02-21 |
68% |
||
NCT07221474 |
INTerpath-13 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
2029-07-02 |
68% |
2026-05-27 |
Primary Endpoints|Treatments |
NCT06961006 |
INTerpath-012 | P2 |
Recruiting |
Melanoma|Parkinson's Disease|Lewy Body Disease |
2028-07-22 |
52% |
2026-04-14 |
Primary Endpoints|Treatments |