Genmab Takes Full Control of Acasunlimab Development Program

Company Announcement

• Genmab to assume sole responsibility for the continued development and potential commercialization of acasunlimab
• BioNTech has opted not to participate in the further development of the acasunlimab program under the parties’ existing collaboration agreement
• The overall collaboration between the companies to continue unchanged
  
  

COPENHAGEN, Denmark; August 5, 2024 – Genmab A/S (Nasdaq: GMAB) announced today that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab. BioNTech SE (BioNTech) 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.

“Genmab’s partnership with BioNTech is a highly successful one. Together, we have demonstrated acasunlimab’s potential to impact patients with metastatic non-small cell lung cancer, as evidenced by the promising initial results presented at the 2024 American Society of Clinical Oncology Meeting,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Genmab is exceptionally well-positioned to maximize the potential of acasunlimab, and we are confident about the prospect of taking acasunlimab into late-stage development as our second wholly owned Genmab asset in addition to Rina-S. We look forward to our continued partnership with BioNTech on other pipeline programs.”

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.

About Acasunlimab (GEN1046)
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.