Our Programs

BI-1808 is a first-in-class drug candidate in clinical development for the treatment of solid tumors and T-cell lymphoma. BI-1808 has shown single agent activity and excellent tolerability in a clinical Phase 2a study and signs of efficacy and favorable safety profile in combination with pembrolizumab in an ongoing Phase 1/2a study. The antibody BI-1808 is directed towards TNFR2 which has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapies.

Solid tumors

BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent’s first-in-class anti-TNFR2 antibody currently in a Phase 1/2a trial. Both monoclonal antibodies were chosen as potential best-in-class, from a large family of binders generated through BioInvent’s proprietary F.I.R.S.T™ technology platform.

FcγRIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking the receptor FcγRIIB on tumor cells, BI-1206 is expected to recover and enhance the activity of rituximab and acalabrutinib in the treatment of several forms of NHL. In February 2024, a clinical supply agreement was signed with AstraZeneca to evaluate BI-1206 in combination with rituximab and Calquence (acalabrutinib). The rituximab combination trial in NHL has been expanded to include the triplet arm. The first patient was enrolled in September 2024. The combination of drugs could provide a new and important option for patients suffering from NHL and represents a substantial commercial opportunity.

The ongoing clinical program addresses the ability of BI-1206 to target an important mechanism of resistance to PD-1 inhibition, providing a way to enhance anti-tumor immune responses in patients with solid tumors. BI-1206 in combination with pembrolizumab has led to responses in melanoma patients who previously failed on anti-PD1 therapy. Phase 1 data in solid tumors verify preclinical findings that BI-1206 significantly enhances the effect of anti-PD-1. Based on this evidence, MSD and BioInvent have agreed to further investigate the synergies between BI-1206 and pembrolizumab in earlier lines of treatment. The upcoming Phase 2a study of BI-1206 in combination with pembrolizumab is planned to be performed in treatment-naïve patients with NSCLC and uveal melanoma.

BI-1607 is an FcγRIIB-blocking antibody that differs from BI-1206 in that it has been engineered for reduced Fc-binding to FcγRs. BI-1607 can be viewed as a platform to enhance efficacy and overcome resistance to existing cancer treatments, such as targeted monoclonal antibodies and immune checkpoint inhibitors. In July 2024, a clinical trial and supply agreement with Merck was announced to support the expansion of the BI-1607 program with a new Phase 1b/2a triplet combination study in metastatic melanoma. The study was initiated in December 2024 and will evaluate BI-1607 with a low-dose anti-CTLA-4, ipilimumab, plus KEYTRUDA^® (pembrolizumab). Preclinical studies indicate that a triple combination regimen including BI-1607 could allow the use of lower doses of ipilimumab, potentially achieving increased tolerability and higher efficacy.

BT-001 is a drug candidate being developed in collaboration with the French biotech company Transgene. BT-001 is an oncolytic virus armed with BioInvent’s anti-CTLA-4 antibody. When the virus is infecting the tumor cells it releases the anti-CTLA-4 locally in the tumor, decreasing the risk for systemic side-effects. It is currently evaluated in combination with pembrolizumab in a clinical Phase 1/2a study.