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Oportuzumab monatox - Sesen Bio

Drug Profile

Oportuzumab monatox - Sesen Bio

Alternative Names: Anti-ECAM exotoxin A fusion protein; Proxinium; VB-4847; VB-845; VB4-845; Vicinium

Latest Information Update: 14 Jun 2019

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At a glance

  • Originator University of Zurich
  • Developer National Cancer Institute (USA); Sesen Bio; Viventia Biotechnologies
  • Class Antineoplastics; Drug conjugates; Immunotoxins; Monoclonal antibodies; Recombinant fusion proteins
  • Mechanism of Action Protein synthesis inhibitors
  • Orphan Drug Status

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

    Yes - Head and neck cancer
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Bladder cancer
  • Phase II/III Head and neck cancer
  • No development reported Liver cancer; Ovarian cancer

Most Recent Events

  • 05 Nov 2019 Sesen Bio plans a Type B CMC meeting to discuss the submission strategy of the CMC module 3, in December 2019
  • 29 Oct 2019 Sesen Bio announces intention to submit BLA to US FDA under a rolling review for Bladder cancer in December 2019
  • 11 Jun 2019 Sesen Bio completes Type B Pre-BLA meeting with US FDA for Bladder cancer
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