BioNTech abandons late-stage Genmab bispecific antibody

BioNTech, a prominent German biotechnology company, has announced it will no longer co-develop acasunlimab (DuoBody-PD-L1x4-1BB), a bispecific antibody, alongside its partner Genmab. This decision, disclosed in BioNTech's second-quarter financial results, is attributed to strategic portfolio considerations. Despite encouraging clinical results, BioNTech has opted out of participating in the planned phase 3 trial for this investigational therapy.

The long-standing collaboration between BioNTech and Genmab, which began in 2015 and was expanded in 2022, remains intact. This partnership utilizes Genmab’s proprietary HexaBody technology platform to develop and commercialize new immunotherapy treatments. The 2022 expansion brought into the collaboration monospecific antibody candidates like GEN1053/BNT313, a CD27 antibody.

Initial data from an ongoing phase 2 trial of acasunlimab, shared in June, showed promising outcomes. The study focused on patients with previously treated PD-L1-positive metastatic non-small cell lung cancer who were administered a combination of acasunlimab and pembrolizumab every six weeks. Results revealed a 12-month overall survival rate of 69% and a median overall survival of 17.5 months.

Despite these positive results, BioNTech has chosen not to move forward with acasunlimab. However, Genmab remains committed and plans to initiate the phase 3 study for acasunlimab in the latter half of this year. This announcement follows Genmab’s recent $1.8 billion acquisition of ADC specialist ProfoundBio, further demonstrating the company’s commitment to advancing its oncology pipeline.