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Fibromun - Philogen

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Drug Profile

Fibromun - Philogen

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

Latest Information Update: 19 Apr 2024

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At a glance

  • Originator Philogen
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies; Recombinant fusion proteins; Tumour necrosis factors
  • Mechanism of Action Immunostimulants
  • 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 Glioma; Leiomyosarcoma
  • Phase I/II Glioblastoma
  • No development reported Colorectal cancer; Malignant melanoma; Solid tumours

Most Recent Events

  • 05 Apr 2024 Philogen withdraws the planned phase-IGLIOASTRA trial in Glioblastoma (Combination-therapy) (IV, Infusion), prior to enrollment initiation since the Sponsor had no further plan for the study in object (NCT05304663)
  • 20 Feb 2024 Philogen plans a phase II trial for Glioblastoma in USA
  • 07 Nov 2023 The US FDA approves a phase II trial for glioblastoma (Combination therapy) in the US (before November 2023)

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