European Commission grants orphan designation to VCN-01 for retinoblastoma

Theriva Biologics, Inc.

Orphan medicinal product designation granted by European Commission for VCN-01 oncolytic adenovirus to treat retinoblastoma.
FDA previously granted orphan drug and rare pediatric disease designations for same indication.
Designation provides 10-year EU market exclusivity post-approval, protocol assistance, and fee reductions.
Phase 1 trial in pediatric refractory retinoblastoma showed encouraging safety/activity with intravitreal VCN-01.
Company working with physicians and regulators on VCN-01 as adjunct to chemotherapy.

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