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 could represent a new class of immunomodulatory agent with the potential to improve efficacy of cancer therapy
STATUS
Efficacy in clinical Phase 1/2a study (NCT04752826) in solid tumors
Monotherapy data in solid tumors disclosed earlier in the year, show one complete response (CR), one partial response (PR) and nine patients with stable disease (SD) (26 evaluable patients), presented at the American Society of Clinical Oncology conference (ASCO) in June 2024. The patient with PR is doing well and has completed study treatment. This patient will continue the treatment outside of the study (per patient treatment). Early signs of efficacy and favorable safety profile in the Phase 1 dose escalation part studying BI-1808 in combination with KEYTRUDA® (pembrolizumab) were also presented at ASCO.
The Phase 2a combination arm of the study evaluating BI-1808 with pembrolizumab is ongoing.
STUDY DESIGN
During the first part of the Phase 1/2a study 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 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 include ovarian cancer, all tumor types and T-cell lymphoma (including CTCL).
Read more about the ongoing Phase 1/2a study KEYNOTE-D20
Evaluation of BI-1808 for the treatment of solid tumors and T-cell lymphomas.
OUT-LICENSING AND PARTNERING
Since August 2021, BioInvent has a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the combination of BI-1808 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).