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FLYSYN

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Drug Profile

FLYSYN

Alternative Names: 4G8-SDIEM

Latest Information Update: 21 May 2022

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At a glance

  • Originator Synimmune
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Acute myeloid leukaemia

Most Recent Events

  • 08 Apr 2022 Updated efficacy data from a phase I/II trial in Acute myeloid leukaemia presented at the 113th Annual Meeting of the American Association for Cancer Research (AACR-2022)
  • 27 Sep 2021 Synimmune in collaboration with University Hospital Tubingen completes a phase Ib/IIa trial in Acute myeloid leukaemia (Monotherapy) in Germany (IV) (NCT02789254)
  • 06 Sep 2021 GenScript ProBio and Synimmune enters into manufacturing agreement for technology transfer and manufacturing of drug substance and drug product for clinical phase II trial of FLYSYN antibody
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