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BI-1808 in solid tumors and CTCL

Target: TNFR2 Status: Phase 1 Partner: MSD (Merck)


Project status and outlook
Access to Keytruda secured
After the end of the period, in early August 2021, a second clinical trial collaboration and supply agreement was signed with Merck, giving access to Keytruda® (pembrolizumab) for the continued clinical development of BI-1808. The agreement supports the strong rationale for combining antiTNFR2 and pembrolizumab in the ongoing Phase 1/2a trial.

IND approval from the FDA
In April 2021, the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) for the BI-1808 Phase 1/2a clinical study. The study will be conducted in Denmark, Hungary, the United Kingdom and Russia. Since January 2021, patient enrollment is ongoing in Europe to the first part of the Phase 1/2a study evaluating the safety, tolerability and potential signs of efficacy of BI-1808 as a single agent and in combination with the anti-PD-1 therapy Keytruda in patients with ovarian cancer, non-small cell lung cancer and CTCL. The study (NCT04752826) is expected to enroll a total of approximately 120 patients.

Dose escalation to determine the recommended single agent Phase 2 dose
The ongoing Phase 1 component of the study is divided into two parts: Part A is a dose escalation study of BI-1808 to assess safety, tolerability, pharmacokinetics/pharmacodynamics, and to determine the recommended single agent Phase 2 dose (RP2D). Part B will explore the safety and tolerability of BI-1808 in combination with Keytruda.

The subsequent Phase 2a component consists of expansion cohorts to assess signs of efficacy of BI-1808 as single agent, as well as in combination with Keytruda in lung cancer and ovarian cancer patients. Another cohort will explore the activity as single agent in cutaneous T-cell lymphoma (CTCL).

The anti-TNFR2 antibody BI-1808 is a first-in-class drug candidate and is part of BioInvent’s tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the TME and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapies. Two different types of TNFR2 targeting antibodies are being developed by BioInvent. In addition to BI-1808, the company also has BI-1910 (a TNFR2 agonist) in preclinical development.