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Intismeran autogene - Merck/Moderna Therapeutics

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Drug Profile

Intismeran autogene - Merck/Moderna Therapeutics

Alternative Names: mRNA-4157; mRNA-4157/V940; PCV; Personalised cancer vaccine - Moderna Therapeutics; V-940

Latest Information Update: 27 Jun 2025

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At a glance

  • Originator Moderna Therapeutics
  • Developer Merck Sharp & Dohme; Moderna Therapeutics
  • Class Antineoplastics; Cancer vaccines; Immunotherapies; RNA vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Malignant melanoma; Non-small cell lung cancer
  • Phase II/III Squamous cell cancer
  • Phase II Bladder cancer; Renal cell carcinoma
  • Phase I Solid tumours

Most Recent Events

  • 29 May 2025 Phase-II clinical trials in Malignant melanoma (Late-stage disease, Inoperable/Unresectable, First-line therapy, Combination therapy) in USA, Australia, Poland, Israel, Norway, Hungary, Slovakia, Finland, Greece, Estonia, Denmark, Portugal, France, Ireland, Germany, Latvia, Czech Republic, Lithuania, Belgium, Spain, Italy (IM) (NCT06961006) (EUCT2023-504923-20-00-V940-002)
  • 13 May 2025 Phase-III clinical trials in Malignant melanoma (Combination therapy, Metastatic disease, Adjuvant therapy) in Argentina, Japan, South Korea (IM) (NCT05933577)
  • 07 May 2025 Merck Sharp & Dohme LLC plans to initiate a phase II trial for Malignant Melanoma (Late-stage disease, Combination therapy, First-line therapy, Inoperable/Unresectable) (IM) (NCT06961006)

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