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Autogene cevumeran - Genentech

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Drug Profile

Autogene cevumeran - Genentech

Alternative Names: BNT-122; BNT122/RO7198457; Individualized Neoantigen Specific immunotherapy; iNeST; IVAC_M_uID; PCV RO7198457; Personalized cancer vaccine RO7198457; RG-6180; RG6180-1; RO-719845; RO-7198457

Latest Information Update: 12 May 2026

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At a glance

  • Originator BioNTech
  • Developer BioNTech; Genentech; Memorial Sloan-Kettering Cancer Center; Roche
  • 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 II Adenocarcinoma; Colorectal cancer; Malignant melanoma; Urogenital cancer
  • No development reported Pancreatic cancer; Triple negative breast cancer

Most Recent Events

  • 12 May 2026 Roche plans to file regulatory application of Autogene cevumeran for the treatment of Solid tumours in or after 2029 (Roche pipeline, May 2026)
  • 10 Mar 2026 BioNTech terminates phase II IMCODE004 trial in Urogenital cancer (Combination therapy, Adjuvant therapy) in Australia, the US, Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Italy, South Korea, Mexico, Netherlands, Norway, Poland, Spain, Sweden, Taiwan, the United Kingdom (IV), due to business decision(NCT06534983)
  • 03 Nov 2025 Efficacy and adverse events data from a phase II trial in Malignant melanoma released by BioNTech

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