Drug Profile


Alternative Names: Autologous tumour cell-based vaccine; Bystander vaccine; Bystander-based autologous tumour cell vaccine; CD40LGVAX; Dendristim vaccine; GM-CSF/CD40L; GM.CD40L; GM.CD40L bystander vaccine; hCD40L/hGM-CSF

Latest Information Update: 16 Jul 2016

Price : $50

At a glance

  • Originator University of South Florida
  • Developer H. Lee Moffitt Cancer Center and Research Institute
  • Class Antineoplastics; Cancer vaccines; CD antigens; Cell therapies; Gene therapies; Granulocyte-macrophage colony-stimulating factors; Immunotherapies
  • Mechanism of Action CD40 antigen stimulants; Granulocyte colony stimulating factor stimulants; Immunostimulants
  • Orphan Drug Status

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

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No

Highest Development Phases

  • Phase II Lung cancer; Malignant melanoma
  • No development reported Myelodysplastic syndromes

Most Recent Events

  • 16 Jul 2016 No recent reports of development identified for phase-I development in Myelodysplastic-syndromes(Combination therapy, Second-line therapy or greater) in USA (Intradermal, Injection)
  • 14 Aug 2015 Cellular Biomedicine announces intention to submit NDA to the US FDA
  • 14 Aug 2015 Cellular Biomedicine plans a phase I/II trial for Non-small cell lung cancer in USA , (NCT02466568)
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