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Gotistobart - OncoC4

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Drug Profile

Gotistobart - OncoC4

Alternative Names: BNT-316; humanized anti-CTLA4 IgG1 monoclonal antibody; ONC-392

Latest Information Update: 28 Dec 2025

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At a glance

  • Originator OncoImmune
  • Developer BioNTech; OncoC4; OncoImmune
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T-lymphocyte antigen 4 inhibitors; T lymphocyte stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Non-small cell lung cancer
  • Phase II Ovarian cancer
  • Phase I/II Prostate cancer; Solid tumours

Most Recent Events

  • 28 Dec 2025 No recent reports of development identified for phase-I development in Non-small-cell-lung-cancer(Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Hungary (IV, Infusion)
  • 28 Dec 2025 No recent reports of development identified for phase-I development in Non-small-cell-lung-cancer(Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Poland (IV, Infusion)
  • 28 Dec 2025 No recent reports of development identified for phase-I development in Non-small-cell-lung-cancer(Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Spain (IV, Infusion)

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