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Onfekafusp alfa - Philogen

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Drug Profile

Onfekafusp alfa - Philogen

Alternative Names: Fibromun; L19 TNF fusion protein; L19-hTNF; L19-TNF; L19-TNF-alpha; L19TNFALFA; Onfekafusp alfa; onfekafusp alpha

Latest Information Update: 20 Aug 2025

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At a glance

  • Originator Philogen
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies; Recombinant fusion proteins; Tumour necrosis factors
  • Mechanism of Action Tumour necrosis factor alpha replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Soft tissue sarcoma
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Soft tissue sarcoma
  • Phase II Glioblastoma; Glioma; Leiomyosarcoma
  • No development reported Colorectal cancer; Malignant melanoma; Solid tumours

Most Recent Events

  • 13 Aug 2025 Philogen plans a phase II IMAGLIO trial for Glioma (Second-line therapy or greater) in January 2026 (NCT07120984)
  • 25 Apr 2025 Pharmacodynamics data from a preclinical study in Colorectal cancer presented at the 116th Annual Meeting of the American Association for Cancer Research (AACR-2025)
  • 04 Feb 2025 Philogen completes enrollment of phase FIBROSARC III trials in Soft tissue sarcoma (Combination therapy, First-line therapy, Late-stage disease, Metastatic disease) in Italy, France, Poland and Germany (IV)

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