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Ficerafusp alfa - Bicara Therapeutics

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Drug Profile

Ficerafusp alfa - Bicara Therapeutics

Alternative Names: BCA-101; EGFR/TGFβ fusion monoclonal antibody - Bicara Therapeutics

Latest Information Update: 16 Oct 2025

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At a glance

  • Originator Bicara Therapeutics
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies; Recombinant fusion proteins
  • Mechanism of Action Antibody-dependent cell cytotoxicity; 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 II/III Squamous cell cancer
  • Phase I Solid tumours

Most Recent Events

  • 13 Oct 2025 Ficerafusp alfa receives Breakthrough Therapy status for Squamous cell cancer (Combination therapy, First-line therapy, Inoperable/Unresectable, Metastatic disease, Recurrent) in USA
  • 01 Jun 2025 Updated efficacy data from a phase I/Ib trial in Solid tumours released by Bicara Therapeutics
  • 30 May 2025 Updated adverse events, efficacy and pharmacodynamics data from a phase-I/Ib trial in Solid tumours presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)

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