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Nalotimagene carmaleucel - AGC Biologics

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Drug Profile

Nalotimagene carmaleucel - AGC Biologics

Alternative Names: Herpes simplex virus thymidine kinase (HSV-Tk) donor lymphocytes; HSV-Tk; TBI-0301; Thymidine kinase cell therapy - AGC Biologics; TK; TK cell therapy - AGC Biologics; Zalmoxis

Latest Information Update: 02 Oct 2021

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At a glance

  • Originator MolMed
  • Developer AGC Biologics
  • Class Cell therapies; Gene therapies; Gene-directed enzyme-prodrug therapies; T lymphocyte cell therapies
  • Mechanism of Action Gene transference; Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

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

    Yes - Haematological malignancies; Leukaemia
  • New Molecular Entity No

Highest Development Phases

  • Marketed Leukaemia

Most Recent Events

  • 01 Mar 2018 Launched for Leukaemia (Adjunctive treatment) in Italy (IV)
  • 26 Feb 2018 Launched for Leukaemia (Adjunctive treatment) in Germany (IV) before February 2018
  • 25 Jul 2017 Dompe acquires license and distribution rights to thymidine kinase cell therapy in European Economic Area (EEA), and option rights for Australia, Switzerland and Turkey for Haematological malignancies

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