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Bifikafusp alfa + onfekafusp alfa - Philogen

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Drug Profile

Bifikafusp alfa + onfekafusp alfa - Philogen

Alternative Names: Bifikafusp alfa + Onfekafusp alfa; Darleukin + Fibromun; Darleukin/fibromun; Daromun; L19-IL2 + L19-TNF; L19IL2-L19TNF; L19IL2/L19TNF; NIDLEGY; Nidlegy

Latest Information Update: 02 Jan 2025

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At a glance

  • Originator Philogen
  • Class Antineoplastics; Cytokines; Immunotherapies; Interleukins; Monoclonal antibodies; Recombinant fusion proteins; Tumour necrosis factors
  • Mechanism of Action Angiogenesis inhibitors; Antibody-dependent cell cytotoxicity; Immunostimulants; Interleukin 2 receptor agonists; Tumour necrosis factor alpha stimulants
  • Orphan Drug Status

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

    Yes - Malignant melanoma
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Malignant melanoma
  • Phase II Basal cell cancer; Cutaneous T-cell lymphoma; Kaposi's sarcoma; Merkel cell carcinoma; Skin cancer; Squamous cell cancer
  • No development reported Solid tumours

Most Recent Events

  • 13 Sep 2024 Pharmacodynamics data from a phase III PIVOTAL trial in Malignant melanoma presented at the 49th European Society for Medical Oncology Congress (ESMO-2024)
  • 12 Jul 2024 Phase-II clinical trials in Malignant melanoma (Combination therapy, Second-line therapy or greater, Late-stage disease, Inoperable/Unresectable, Metastatic disease) in USA (Intratumoural) (NCT06284590)
  • 20 Jun 2024 European Medicines Agency (EMA) validates Marketing Authorization Application (MAA) for Bifikafusp alfa + onfekafusp alfa for Malignant melanoma

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