Danish biotechnology company Genmab A/S (CPH:GMAB) announced on Monday that it will assume full responsibility for the continued development and potential commercialisation of acasunlimab (GEN1046).

Genmab's German partner BioNTech SE (Nasdaq:BNTX) has decided to exit the development programme. Genmab will pay milestones and royalties to BioNTech.

The companies' broader collaboration remains intact.

Acasunlimab is an investigational PD-L1x4-1BB bispecific antibody fusing Genmab's proprietary DuoBody technology platform and BioNTech's proprietary immunomodulatory antibodies. It is currently being investigated in three clinical trials: a Phase 1/2 safety and PK trial in patients with multiple solid tumours; a Phase 1 dose escalation trial in patients with advanced solid tumours in Japan; and a randomised Phase 2 safety and efficacy trial with acasunlimab as a monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) who have failed previous standard of care treatments with immune checkpoint inhibitors.

Genmab plans to initiate a Phase 3 study for acasunlimab in the second half of the year.

This change is not expected to impact Genmab's 2024 financial guidance.