BioInvent Receives FDA Orphan Drug Designation for BI-1808 for the Treatment of T-cell Lymphoma
Current TAP Partner
Lund, Sweden – March 20, 2025 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BI-1808, a first-in-class anti-TNFR2 antibody for the treatment of T-cell Lymphoma (TCL).
During the first part of the Phase 1/2a study (NCT04752826) the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent (part A) and in combination with the anti-PD-1 therapy pembrolizumab (part B) are evaluated in patients with advanced solid tumors and T-cell lymphoma. The efficacy of BI-1808 as single agent is currently explored in the Phase 2a part of the trial in a larger sample of patients. Expansion cohorts include ovarian cancer, all tumor types and T-cell lymphomas (including CTCL). The dose escalation in Phase 1 Part B has been completed and the Phase 2a dose expansion study for the combination is ongoing. The expansion cohorts are planned to include ovarian cancer, all tumor types and T-cell lymphoma (including CTCL).
To date, results from the single agent CTCL cohort show three patients with partial response (PR) and one with stable disease (SD) out of four evaluable patients. All these patients had previously deteriorated after standard treatment. These data support the single agent data disclosed earlier in 2024, showing one complete response (CR), one PR and nine patients with SD, presented at the American Society of Clinical Oncology conference (ASCO) in June 2024. Additional data from Phase 2a study of single agent BI-1808 are expected by mid-2025.