Genmab A/S announced that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab. BioNTech SE has opted not to participate in the further development of the acasunlimab program under the parties? existing collaboration agreement.

The program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. Genmab plans to initiate the Phase 3 study in the second half of this year. While the emerging clinical profile of acasunlimab is encouraging, BioNTech informed the company that it has taken this decision for reasons relating to its portfolio strategy.

The companies? long-standing collaboration in antibody science remains in place, and both parties will continue with the existing programs under development under their existing agreements, which were expanded in 2022. The decision by BioNTech to not participate in the further development of the acasunlimab program is not expected to impact Genmab?s 2024 financial guidance.

Acasunlimab (GEN1046) is an investigational PD-L1x4-1BB bispecific antibody fusing Genmab's proprietary DuoBody® technology platform and BioNTech?s proprietary immunomodulatory antibodies. Acasunlimab is designed to elicit an antitumor response via conditional activation of 4-1BB on T cells and natural killer (NK) cells, which is strictly dependent on simultaneous binding of the PD-L1 arm. The candidate is currently being investigated in three clinical trials: a Phase 1/2 safety and PK trial in patients with multiple solid tumors, a Phase 1 dose escalation trial in patients with advanced solid tumors in Japan, and a randomized 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.