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Cemiplimab - Regeneron Pharmaceuticals/Sanofi

Drug Profile

Cemiplimab - Regeneron Pharmaceuticals/Sanofi

Alternative Names: Cemiplimab-rwlc; Libtayo; REGN-2810; SAR-439684

Latest Information Update: 11 Dec 2019

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At a glance

  • Originator Regeneron Pharmaceuticals
  • Developer Columbia University; Inovio Pharmaceuticals; ISA Pharmaceuticals; Regeneron Pharmaceuticals; Replimune; Sanofi; SillaJen Biotherapeutics; University of Texas M. D. Anderson Cancer Center
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T lymphocyte stimulants; Programmed cell death-1 receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Squamous cell cancer
  • Phase III Cervical cancer; Non-small cell lung cancer
  • Phase II Basal cell cancer; Glioblastoma; Head and neck cancer; Liver cancer; Oropharyngeal cancer; Prostate cancer
  • Phase I/II Fallopian tube cancer; Multiple myeloma; Ovarian cancer; Peritoneal cancer; Solid tumours
  • Phase I B-cell lymphoma; Cancer; Malignant melanoma; Renal cell carcinoma

Most Recent Events

  • 04 Dec 2019 Regeneron Pharmaceuticals initiates a phase II trial for Squamous cell cancer (Neoadjuvant therapy, Metastatic disease) in USA (IV) (NCT04154943)
  • 14 Nov 2019 BioNTech and Regeneron enters into a clinical trial supply agreement to supply cemiplimab for a phase I/II trial in prostate cancer
  • 14 Nov 2019 BioNTech plans a phase I/II trial in Prostate cancer (Newly diagnosed, Metastatic disease, Hormone-refractory, Monotherapy, Combination therapy), in the fourth quarter of 2019 (BioNTech pipeline, November 2019)
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