The US FDA Grants Fast Track Designation to Theriva Biologics’ VCN-01 as 1L Treatment of PDAC
Shots:
- The US FDA has granted fast-track designation to the company’s VCN-01 (IV) + CT (gemcitabine/nab-paclitaxel) for PDAC and previously received ODD
- The company’s VCN-01 is being evaluated in P-IIb (VIRAGE) study to treat metastatic PDAC; patient enrolment completion is anticipated in Q3’24
- VCN-01, an oncolytic adenovirus administered to over 80 patients in P-I and investigator-sponsored trials to treat PDAC (in combination with chemotherapy), HNSCC (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection)
Ref: Theriva Biologics | Image: Theriva Biologics
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com