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EMA Positive Opinion for Orphan Drug Designation to BioInvent's BI‑1808 for the Treatment of Cutaneous T-cell Lymphoma
LUND, SE / ACCESS Newswire / November 17, 2025 /BioInvent International AB ("BioInvent")(Nasdaq Stockholm: BINV)(STO:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer ...
About this update from Bioinvent International Ab
[{"type":"text","content":"LUND, SE / ACCESS Newswire / November 17, 2025 / BioInvent International AB ("BioInvent")(Nasdaq Stockholm: BINV)(STO:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has adopted a positive opinion for Orphan Drug Designation (ODD) to the company's investigational medicinal product BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of Cutaneous T-cell Lymphoma (CTCL). The European Commission is now assessing the opinion and is expected to grant the designation within 30 days.","length":719,"tagName":"p"},{"type":"text","content":"T-cell lymphomas include a number of subtypes of T cell-derived non-Hodgkins's lymphoma, including CTCL. CTCL is a rare and aggressive form that originates in T-lymphocytes residing in the skin. It typically manifests with persistent skin lesions, itching, and potential systemic complications, significantly impacting patients' quality of life. CTCL meets the EMA's criteria for orphan designation, affecting fewer than 5 in 10,000 individuals in the EU. Although specific European incidence data are limited, CTCL is globally recognized as a rare disease, with approximately 3,700 new cases diagnosed annually in the 27 European member states, plus Norway and Iceland.[1]","length":685,"tagName":"p"},{"type":"text","content":""The positive opinion by the EMA which underscores the potential of our anti-TNFR2 approach to address serious and underserved hematologic malignancies", said Martin Welschof, Chief Executive Officer of BioInvent. "This designation, along with encouraging clinical data, supports our commitment to advancing BI-1808 as a novel immunotherapy for CTCL patients."","length":380,"tagName":"p"},{"type":"text","content":"The EMA's Orphan Drug Designation is intended to promote the development of drugs for rare diseases and provides incentives such as protocol assistance, reduced regulatory fees, and ten years of market exclusivity upon approval[2].","length":235,"tagName":"p"},{"type":"text","content":"BI-1808 has demonstrated promising clinical activity in an ongoing Phase 2a trial with 100% disease control rate and a majority...