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www.fdanews.com/articles/206508-vcn-biosciences-granted-orphan-drug-designation-for-retinoblastoma

VCN Biosciences Granted Orphan Drug Designation for Retinoblastoma

February 9, 2022

The FDA has granted VCN Biosciences Orphan Drug designation for retinoblastoma, a rare eye cancer that begins in the retina.

The company is developing an oncolytic adenovirus platform designed to trigger tumor cell death and promote immune cell infiltration into tumors.

VCN is in the process of being acquired by Synthetic Biologics, which said it will conduct a pivotal phase 2/3 trial in retinoblastoma patients once the acquisition is complete.

There are fewer than 20,000 cases of retinoblastoma in the U.S. per year. The FDA grants orphan status to drugs being developed to treat, diagnose or prevent a rare disease or condition affecting fewer than 200,000 people in the U.S.

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