BioNTech withdraws from PD-L1 development with Genmab and reports quarterly losses

The German pharmaceutical company BioNTech has terminated its collaboration with the Danish firm Genmab for the joint development of the cancer therapy acasunlimab (BNT311/GEN1046). BioNTech announced this in its report on the second-quarter loss results. The company reported a net loss of 807.8 million euros, while revenue in the second quarter dropped to 128.7 million euros, compared to 167.7 million euros in the previous year. BioNTech cited the decline in global sales of Covid-19 vaccines as the main reason for the revenue drop. Despite the losses, the company remains optimistic about achieving the planned annual revenue target of 2.5 to 3.1 billion euros for 2024. Additionally, BioNTech announced it will not continue the development of acasunlimab to Phase III despite positive interim results from Phase II. The responsibility for the program will now be fully handed over to Genmab. The bispecific antibody is currently being studied in a Phase II trial for the treatment of non-small cell lung cancer. The interim results show a 12-month overall survival rate of 69 percent and a median overall survival time of 17.5 months in combination with Keytruda from MSD. Genmab plans to present updated data at the World Conference on Lung Cancer from September 7 to 10. The separation comes after BioNTech and Genmab had expanded their clinical collaboration in 2022 to explore, develop, and market novel mono-specific antibody candidates for various cancer indications. However, the companies have not announced any plans to terminate the joint development of their other cancer projects, including BNT-313 and BNT-312. BioNTech emphasized its continued focus on developing its antibody-drug conjugate (ADC) pipeline, which includes BNT323/DB-1303 and BNT324/DB-1311, both shared projects with Duality Biologics. The company has also realigned its vaccine strategy and plans to sell tailored Covid-19 vaccines that specifically target the Omicron variant JN.1. This is based on updated guidelines from the World Health Organization, the U.S. Food and Drug Administration, and other regulatory agencies that have recommended a monovalent Covid-19 vaccination for Omicron JN.1 this year. CEO Dr. Ugur Sahin commented in the second-quarter financial report: “We have started to market variant-adapted Covid-19 vaccines for the upcoming season while simultaneously accelerating our clinical development to realize the full potential of our technologies. We are making progress on our path to becoming a company with marketed drugs for cancer and infectious diseases.”