Clinical programs

BI-1808 is aimed for the treatment of solid tumor disease such as non-small cell lung cancer (NSCLC) and ovarian cancer. It is currently evaluated in a clinical Phase 1/2a trial which will study BI-1808 as a single agent as well as in combination with pembrolizumab. The anti-TNFR2 antibody BI-1808 is a first-in-class drug candidate. TNFR2 has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapies.

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 ongoing rituximab combination trial in NHL will be expanded to include the triplet arm. 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.

BI-1607 is an FcγRIIB-blocking antibody that differs from BI-1206 in that it has been engineered for reduced Fcbinding 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 2 triplet combination study in metastatic melanoma. The study 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.