In This Article:
LUND, SE / ACCESS Newswire / March 21, 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 announced that one of the company's lead program; BI-1808 as monotherapy in Cutaneous T Cell Lymphoma (CTCL) will be presented at the 16th Annual T-Cell Lymphoma Forum held March 20-22, 2025 in La Jolla, California.
The data, previously disclosed in a press release in September 2024, will be featured in a poster presentation highlighting the early efficacy of BI-1808 monotherapy in the ongoing Phase 2a dose expansion study in CTCL. So far three partial responses (PR) and one stable disease (SD) out of four evaluable patients have been reported. The Company anticipates reporting additional data from the study in mid-2025.
BI-1808, a first-in-class anti-TNFR2 antibody, was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of TCL.
Poster presentation details:
Title: Evidence of T reg depletion and Corresponding Early Efficacy after Tumor Necrosis Factor Receptor 2 (TNFR2) Blockade by BI-1808 in Cutaneous T Cell Lymphoma (CTCL) Patients
Session Date and Time: March 21st, 2025, 5:30 pm PT
Lead Author: Stefan Barta, University of Pennsylvania Hospital, PA, USA
Abstract Number: TCLF34
The poster will be uploaded on the company website in the Scientific Publications section: https://www.bioinvent.com/en/our-science/scientific-publications.
About BI-1808
The anti-TNFR2 antibody BI-1808 is part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapy. BI-1808 is a first-in-class drug candidate in clinical development for the treatment of solid tumors and blood cancer. BI-1808 has shown single agent activity and excellent tolerability in an ongoing Phase 2a study and signs of efficacy and favorable safety profile in combination with pembrolizumab in the ongoing Phase 1/2a study.
About the Phase 1/2a study
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 lymphoma (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).