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Bi-shRNAfurin and GMCSF augmented autologous tumour cell immunotherapy - Gradalis/Mary Crowley Cancer Research Center

Drug Profile

Bi-shRNAfurin and GMCSF augmented autologous tumour cell immunotherapy - Gradalis/Mary Crowley Cancer Research Center

Alternative Names: bi-shRNA(furin)/GMCSF DNA/autologous tumor cell vaccine; Bi-shRNAfurin; FANG™; Vigil™

Latest Information Update: 25 Sep 2023

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At a glance

  • Originator Gradalis; Mary Crowley Cancer Research Center
  • Developer Genentech; Gradalis; Mary Crowley Cancer Research Center
  • Class Antineoplastics; Cancer vaccines; Cell therapies; Gene therapies; Immunotherapies; RNA; 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
  • Phase II Breast cancer; Cervical cancer; Endometrial cancer; Fallopian tube cancer; Gynaecological cancer; Ovarian cancer; Peritoneal cancer; Uterine cancer
  • No development reported Cancer; Colorectal cancer; Lung cancer; Solid tumours
  • Discontinued Liver metastases; Malignant melanoma

Most Recent Events

  • 22 Sep 2023 Gradalis plans a phase II trial in Ovarian cancer (Recurrent) .
  • 21 Dec 2022 US FDA gives clearance for registrational phase III VITAL-V trial in Ovarian cancer
  • 21 Dec 2022 Gradalis plans a phase III trial in Ovarian cancer (Late-stage disease and Newly diagnosed) in USA in 2H of 2023 (Intradermal)
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