Swedish biotech company BioInvent International AB (STO:BINV) announced on Monday that the European Medicines Agency's Committee for Orphan Medicinal Products has issued a positive opinion recommending Orphan Drug Designation for BI-1808 in cutaneous T-cell lymphoma (CTCL).

The European Commission is expected to confirm this designation within 30 days.

BI-1808 is a first-in-class anti-TNFR2 antibody, currently in a Phase 2a trial that has reported a 100% disease control rate among nine evaluable CTCL patients, including one complete response, four partial responses, and four stable diseases.

The treatment has shown a favourable safety profile with mostly mild to moderate adverse events. Additional data will be presented at the 2025 ASH Annual Meeting.

CTCL is a rare, aggressive form of T-cell lymphoma affecting fewer than 5 in 10,000 people in the EU, with approximately 3,700 new cases annually across EU member states, Norway, and Iceland.

BI-1808 has also received Fast Track Designation and Orphan Drug Designation in the United States for related T-cell lymphoma indications.