BioNTech bails on late-stage Genmab bispecific antibody

Aug. 5, 2024

Despite "encouraging" clinical results, BioNTech will no longer participate in the further development of acasunlimab (DuoBody-PD-L1x4-1BB), a bispecific antibody, with partner Genmab.

The German biotech revealed its decision to not participate in the planned phase 3 trial in its second quarter financial results, noting "reasons relating to portfolio strategy."

The collaboration — which will continue unchanged — leverages Genmab’s proprietary HexaBody technology platform to develop and commercialize novel immunotherapy candidates. It was originally inked in 2015, and expanded in 2022. The expansion added monospecific antibody candidates to the collab, specifically GEN1053/BNT313, a CD27 antibody.

Now, BioNTech is walking away from acasunlimab despite a positive phase 2 trial. Initial data from the ongoing trial, shared in June, showed a 12-month overall survival rate of 69% and a median overall survival of 17.5 months in patients with previously treated PD-L1-positive metastatic non-small cell lung cancer treated with a combination of acasunlimab and pembrolizumab every six weeks.

Genmab, fresh off a $1.8 billion acquistion of ADC specialist ProfoundBio, says it plans to initiate the phase 3 study for acasunlimab in the second half of this year.