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Bifikafusp alfa + onfekafusp alfa - Philogen

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; NidlegyTM

Latest Information Update: 22 Nov 2023

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At a glance

  • Originator Philogen
  • Class Antineoplastics; Cytokines; Immunotherapies; Monoclonal antibodies; Recombinant fusion proteins
  • 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

  • Phase III 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

  • 07 Nov 2023 Philogen completes the phase III PIVOTAL trial in Malignant melanoma (Late-stage disease, Metastatic disease, Neoadjuvant therapy) in Italy, Germany, Poland and France (Intratumoural) (before November 2023) (NCT02938299)
  • 20 Oct 2023 Efficacy and safety data from the phase II DUNCAN trial for Basal cell cancer and Squamous cell cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)
  • 16 Oct 2023 Philogen announces intention to launch in Europe, Australia and New Zealand for Malignant melanoma
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