Dinutuximab beta - Apeiron Biologics

Drug Profile

Dinutuximab beta - Apeiron Biologics

Alternative Names: APN 311; ch14.18/CHO; Dinutuximab beta Apeiron; ISQETTE

Latest Information Update: 16 May 2017

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At a glance

  • Originator Children's Cancer Research Institute
  • Developer Apeiron Biologics; Children's Cancer Research Institute; Nagoya University; SIOPEN
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action GD2 ganglioside inhibitors; Immunostimulants
  • Orphan Drug Status

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

    Yes - Neuroblastoma
  • New Molecular Entity No

Highest Development Phases

  • Registered Neuroblastoma

Most Recent Events

  • 18 Dec 2017 Apeiron Biologics announces intention to submit BLA to US FDA for Neuroblastoma in 2018
  • 10 May 2017 Registered for Neuroblastoma (Combination therapy, In adolescents, In children, In infants, Recurrent, Refractory metastatic disease, Second-line therapy or greater, In adults) in European Union (IV)
  • 10 May 2017 Registered for Neuroblastoma (Combination therapy, In adolescents, In children, In infants, Recurrent, Refractory metastatic disease, Second-line therapy or greater, In adults) in Liechtenstein, Iceland, Norway (IV)
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