BioNTech halts development of Genmab-collaborated bispecific antibody acasunlimab

BioNTech has decided to withdraw from the development of the bispecific antibody acasunlimab, citing reasons related to its portfolio strategy. Despite the encouraging clinical profile of acasunlimab, BioNTech will no longer pursue its involvement in the upcoming phase 3 trials, leaving its partner Genmab to proceed independently.

Acasunlimab, a PD-L1x4-1BB bispecific antibody, is designed to stimulate an anti-tumor response by activating the 4-1BB receptor on T cells and natural killer cells. BioNTech and Genmab had been jointly testing the drug in three clinical trials, including a phase 2 study. The trials evaluated acasunlimab both as a monotherapy and in combination with Merck & Co.’s PD-1 inhibitor, Keytruda, in patients with non-small cell lung cancer (NSCLC) who had not responded to standard-of-care treatments with immune checkpoint inhibitors.

This morning, BioNTech announced that, although the clinical profile of acasunlimab is promising, the company has decided to halt further development due to strategic portfolio considerations. Nevertheless, Genmab quickly declared its intention to commence a phase 3 trial in the second half of this year.

Both companies emphasized that their overall relationship remains strong, unaffected by BioNTech's decision. In 2022, BioNTech and Genmab had broadened their partnership to include the development of monospecific antibody candidates targeting malignant solid tumors. The first candidate to enter clinical trials from this expanded collaboration was the CD27 antibody, GEN1053/BNT313.

Genmab's CEO, Jan van de Winkel, Ph.D., highlighted the success of the partnership with BioNTech and expressed confidence in Genmab’s ability to maximize acasunlimab’s potential. He emphasized Genmab’s readiness to advance acasunlimab into late-stage development as the company's second wholly-owned asset, alongside Rina-S. Van de Winkel also reiterated the company's commitment to continue collaborating with BioNTech on other pipeline programs.

Van de Winkel pointed out that acasunlimab had shown promising initial results in treating patients with metastatic NSCLC. These results were presented at the 2024 American Society of Clinical Oncology Meeting in June. The data revealed a 12-month overall survival rate of 69% in patients with previously treated PD-L1-positive metastatic NSCLC who received a combination of acasunlimab and Keytruda.

BioNTech appeared fully supportive of acasunlimab when these results were announced, celebrating the high survival rate. At that time, BioNTech’s Chief Medical Officer, Özlem Türeci, M.D., acknowledged the limited treatment options available for patients with metastatic NSCLC after the failure of first-line checkpoint inhibitor therapy. She emphasized that the phase 2 trial data indicated that combining acasunlimab with PD-L1 blockade could be a viable option for this heavily pretreated patient population.

While BioNTech has stepped back from acasunlimab's development, Genmab is poised to move forward with its plans to launch a phase 3 trial, demonstrating a commitment to advancing this promising therapeutic candidate. The collaboration between BioNTech and Genmab continues to thrive, with ongoing efforts to develop innovative treatments for malignant solid tumors.

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