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BI 765063

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Drug Profile

BI 765063

Alternative Names: Anti-SIRPa mAb - OSE Therapeutics; Anti-SIRPa monoclonal antibody - OSE Therapeutics; BI-765063; Effi dem; OSE 172

Latest Information Update: 04 Jun 2025

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At a glance

  • Originator Effimune
  • Developer Boehringer Ingelheim; OSE Immunotherapeutics
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; SIRPA protein 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 I Colorectal cancer; Liver cancer; Squamous cell cancer
  • No development reported Solid tumours

Most Recent Events

  • 04 Jun 2025 BI 765063 is still in phase I trials for Squamous cell cancer and Liver cancer (Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) in USA, Italy, France, Japan, Moldova, Mexico, Malaysia, Thailand, United Kingdom, Poland, Romania, Spain (Parenteral) (NCT05249426)
  • 30 May 2025 Preliminary efficacy and adverse event data from a phase I trial in Squamous cell cancer presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)
  • 30 Apr 2025 OSE Immunotherapeutics completes a phase-I trial in Solid tumours in France and Belgium (NCT03990233)

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