As reported by PharmaBiz, the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion supporting Orphan Drug Designation (ODD) for BioInvent’s BI-1808, an investigational anti-TNFR2 antibody aimed at treating cutaneous T-cell lymphoma (CTCL). The European Commission is expected to confirm the designation within 30 days.
About CTCL:
CTCL is a rare subtype of non-Hodgkin’s lymphoma originating in skin-resident T-lymphocytes. It presents with persistent skin lesions, pruritus, and potential systemic involvement, significantly affecting quality of life. The disease meets EMA’s orphan criteria, impacting fewer than 5 in 10,000 individuals in the EU, with roughly 3,700 new cases annually across Europe.
BI-1808 and Its Clinical Promise:
BI-1808 targets TNFR2, a receptor highly expressed on regulatory T cells within the tumor microenvironment, making it a novel immunotherapy candidate. Interim results from an ongoing Phase 2a trial show a 100% disease control rate among nine evaluable CTCL patients, including one complete and four partial responses. The drug has demonstrated good tolerability, with mostly mild to moderate adverse events. Additional data will be presented at the ASH Annual Meeting in December.
Regulatory Incentives and Previous Designations:
Orphan status offers benefits such as reduced fees, protocol assistance, and ten years of market exclusivity upon approval. BI-1808 has also received FDA Fast Track and Orphan Drug Designations for related CTCL subtypes in the U.S.
BioInvent’s Broader Program:
BI-1808 is part of BioInvent’s strategy to target tumor-associated regulatory T cells. The company is advancing multiple candidates in early-phase trials for hematologic cancers and solid tumors.
