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ALE C04

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Drug Profile

ALE C04

Alternative Names: ALE-C04; ALE.C04

Latest Information Update: 02 Jul 2025

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At a glance

  • Originator INSERM; The Mount Sinai Hospital; University of Strasbourg
  • Developer Alentis Therapeutics
  • Class Antineoplastics; Hepatoprotectants; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Immunomodulators
  • 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/II Squamous cell cancer
  • Preclinical Solid tumours
  • No development reported Cholangiocarcinoma; Liver cancer

Most Recent Events

  • 25 Apr 2025 Pharmacodynamics data from a preclinical trial in Solid tumour presented at the 116th Annual Meeting of the American Association for Cancer Research 2025 (ACR-2025)
  • 13 Feb 2025 Alentis Therapeutics terminates a phase I/II trial in Squamous cell cancer (Metastatic disease, Combination therapy, Monotherapy, Recurrent) in USA, Switzerland, Spain, Singapore, Italy, Hong Kong, France, Canada (Parenteral) due to reprioritization (NCT06054477)
  • 28 Aug 2024 No recent reports of development identified for preclinical development in Cholangiocarcinoma in Switzerland (Parenteral)

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