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™; Gemogenovatucel-T; Vigil™

Latest Information Update: 02 Feb 2026

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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.

No
New Molecular Entity No

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; Ewing's sarcoma; Lung cancer; Solid tumours
Discontinued Liver metastases; Malignant melanoma

02 Feb 2026 No development reported - Phase-III for Ewing's Sarcoma (Combination therapy, In adolescents, In children, In the elderly, Second-line therapy or greater, In adults) in USA (Intradermal) (Gradalis website, January 2026)
16 Jan 2026 Efficacy and adverse events data from a phase II VITAL trial for Ovarian cancer released by Gradalis
05 Feb 2025 Bi-shRNAfurin and GMCSF augmented autologous tumour cell immunotherapy - Gradalis/Mary Crowley Cancer Research Center receives Regenerative Medicine Advanced Therapy (RMAT) status for Ovarian cancer in USA

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