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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-7198457

Latest Information Update: 18 Nov 2025

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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; Solid tumours; Triple negative breast cancer

Most Recent Events

  • 03 Nov 2025 Efficacy and adverse events data from a phase II trial in Malignant melanoma released by BioNTech
  • 01 Jul 2025 Genentech completes the phase I trial in Solid tumours (Monotherapy, Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Belgium, Canada, Germany, Netherlands, Spain, Sweden, United Kingdom, USA(IV) (EudraCT2017-001475-23) (NCT03289962)
  • 01 Jul 2025 Roche suspends phase IMCODE004 II trial in Urogenital cancer (Combination therapy, Adjuvant therapy) in Australia, USA, Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Italy, South Korea, Mexico, Netherlands, Norway, Poland, Spain, Sweden, Taiwan and United Kingdom (IV), due to safety event observed in safety run-in population (NCT06534983)

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