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Gotistobart - OncoC4

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Drug Profile

Gotistobart - OncoC4

Alternative Names: BNT-316; ONC-392

Latest Information Update: 14 Nov 2024

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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

  • 04 Nov 2024 US FDA places a clinical hold on phase III trial in Non-small cell lung cancer (Metastatic disease, Monotherapy, Second-line therapy or greater) in Belgium, Canada, France, Germany, Italy, South Korea, Netherlands, Spain, Turkey, United Kingdom, USA, China and Australia (IV)
  • 13 Sep 2024 Efficacy and adverse events data from the phase II PRESERVE-004 trial in Ovarian cancer presented at the 49th European Society for Medical Oncology Congress (ESMO-2024)
  • 06 Dec 2023 Phase-I/II clinical trials in Prostate cancer (Combination therapy, Hormone refractory, Second-line therapy or greater, Metastatic disease) in USA (IV) (NCT05682443)

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