Bi-shRNAfurin and GMCSF augmented autologous tumor cell immunotherapy - Champions Oncology/Gradalis/Mary Crowley

Drug Profile

Bi-shRNAfurin and GMCSF augmented autologous tumor cell immunotherapy - Champions Oncology/Gradalis/Mary Crowley

Alternative Names: Bi-shRNAfurin; bi-shRNAfurin and GMCSF Autologous Tumor Cell Immunotherapy; Engineered Autologous Tumor Cell Immunotherapy; FANG vaccine; FANG™; IND14205; TAG vaccine; TGFbeta2 antisense + rhGMCSF vaccine; Vigil™; Vigil™ EATC

Latest Information Update: 31 Aug 2018

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At a glance

  • Originator Gradalis
  • Developer Gradalis; Mary Crowley Cancer Research Center
  • Class Cancer vaccines; Cell therapies; Gene therapies; Immunotherapies; Tumour cell vaccines
  • Mechanism of Action Furin expression inhibitors; Granulocyte-macrophage colony-stimulating factor expression stimulants; Immunostimulants; RNA interference
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Phase III Ewing's sarcoma; Ovarian cancer
  • Phase II/III Breast cancer; Gynaecological cancer
  • No development reported Solid tumours
  • Discontinued Liver metastases; Malignant melanoma

Most Recent Events

  • 21 Aug 2018 Phase-III clinical trials in Ewing's Sarcoma (In adolescents, In children, Second-line therapy or greater, In adults, Combination therapy, Refractory metastatic disease, Recurrent, In the elderly) in USA (Intradermal) (NCT03495921)
  • 24 Jun 2018 Biomarkers information updated
  • 01 May 2018 Discontinued - Phase-I for Malignant melanoma (Combination therapy, Second-line therapy or greater) in USA (Intradermal) (Gradalis pipeline, August 2018)
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