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Fianlimab - Regeneron Pharmaceuticals

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Drug Profile

Fianlimab - Regeneron Pharmaceuticals

Alternative Names: Anti-LAG-3 antibody - Regeneron Pharmaceuticals; REGN-3767

Latest Information Update: 20 Mar 2025

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At a glance

  • Originator Regeneron Pharmaceuticals
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; CD223 antigen 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 Malignant melanoma
  • Phase II/III Non-small cell lung cancer
  • Phase II Colorectal cancer; Solid tumours
  • Phase I Haematological malignancies

Most Recent Events

  • 20 Mar 2025 Regeneron Pharmaceuticals plans phase-II trial for Malignant melanoma (Combination therapy, In volunteers) in April 2025 (IV) (NCT06848088)
  • 11 Mar 2025 Albert Einstein College of Medicine plans the phase II TRIPL trial for Non-small cell lung cancer (Late-stage disease, Combination therapy, Metastatic disease, Second-line therapy or greater) in USA (IV), in April 2025 (NCT06865339)
  • 13 Jan 2025 Regeneron Pharmaceuticals plans to file an BLA application for fianlimab

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