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A registrational Phase II/III trial of VCN-01 in pediatric patients with advanced retinoblastoma

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Trial Profile

A registrational Phase II/III trial of VCN-01 in pediatric patients with advanced retinoblastoma

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 20 Aug 2026

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At a glance

  • Drugs Topotecan (Primary) ; Zabilugene almadenorepvec (Primary)
  • Indications Retinoblastoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Theriva Biologics

Most Recent Events

  • 11 Aug 2026 According to a Theriva Biologics media release, VCN-01 has Orphan Drug Designation from both the FDA and EMA and Rare Pediatric Disease Designation from the FDA for the treatment of retinoblastoma; if a Biologics License Application (BLA) for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30, 2029, the Company may be eligible to receive a Priority Review Voucher.
  • 11 Aug 2026 According to a Theriva Biologics media release, the company plans to discuss the proposed clinical trial protocol with the FDA in Q3 2026.
  • 05 May 2026 According to a Theriva Biologics media release, the company is continuing discussions with clinicians and key opinion leaders to design a Phase 2/3 clinical trial protocol for the VCN-01 plus topotecan combination in retinoblastoma patients.

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