mRNA-4157

Drug

Also known as: V940

Drug Profile

mRNA-4157 (also known as V940 or intismeran autogene) is an individualized neoantigen mRNA cancer immunotherapy in development, often studied in combination with pembrolizumab. It is being advanced in phase 3 studies for high-risk resected melanoma and has also received breakthrough designation in adjuvant NSCLC with pembrolizumab. It remains investigational and not approved.

Drug Class
Individualized neoantigen mRNA cancer immunotherapy
Approval Status
Investigational candidate in Phase 3 development; no approved marketing status stated.
Mechanism of Action
Custom mRNA neoantigen vaccine approach designed from each patient's tumor mutational signature to stimulate anti-tumor immune responses.
Brand Names
  • V940
  • \Intismeran autogene\
Indications
  • \Adjuvant treatment of high-risk resected stage IIB-IV melanoma (with pembrolizumab, investigational)\
  • \Adjuvant treatment of resected stage II-IIIB NSCLC with PD-L1 TPS >=1% (with pembrolizumab, investigational)\

Related News

Clinical Trial Advances in Cancer Immunotherapy and Targeted Therapies

Moderna and Merck advance a Phase 2 trial of mRNA cancer vaccine V940 with pembrolizumab and chemotherapy for metastatic squamous NSCLC. In biliary tract cancer, first-line treatment combines chemotherapy with immunotherapy, while targeted therapy resistance prompts liquid biopsy. ImmunityBio tests a chemotherapy-free NK-cell regimen in non-Hodgkin lymphoma.

Moderna Beats Q4 Estimates Amid FDA Flu Vaccine Setback

Moderna reported Q4 revenue of $678 million, beating analyst estimates, while posting a narrower-than-expected loss of $2.11 per share. The results came as the FDA refused to review the company's mRNA flu vaccine application.

Related Clinical Trials

NCT ID Title Status Phase
NCT03897881

An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

ACTIVE_NOT_RECRUITING PHASE2
NCT03313778

Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors

ACTIVE_NOT_RECRUITING PHASE1