Monday, February 10, 2025

BioNTech Exits PD-L1 Development Amid Q2 Financial Struggles

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BioNTech has announced its decision to exit the joint development of their cancer programmed-cell death 1 ligand-1 (PD-L1) therapy, acasunlimab (BNT311/GEN1046), with Genmab. This decision comes as the company faces significant Q2 financial losses, reporting a net loss of €807.8m ($885m) and a decline in Q2 revenue to €128.7m from €167.7m in 2023. The drop in global Covid-19 vaccine sales has been cited as the primary reason for this revenue decline. Despite these losses, BioNTech maintains its full-year revenue expectation of €2.5bn-€3.1bn.

In its financial report, BioNTech revealed its plans to discontinue the development of acasunlimab, leaving Genmab to take full control of the program. This decision comes despite positive interim Phase II trial data. The bispecific antibody is currently being evaluated in a Phase II randomized study for non-small cell lung cancer, showing promising results with a 12-month overall survival rate of 69% and a median overall survival of 17.5 months in combination with Keytruda (pembrolizumab). Genmab is set to present updated data at the World Conference on Lung Cancer in September.

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Continued Collaboration and Focus Areas

While BioNTech and Genmab have ended their collaboration on acasunlimab, they continue to jointly develop other cancer assets, including BNT-313 and BNT-312. BioNTech is now focusing on its antibody-drug conjugate (ADC) pipeline, particularly BNT323/DB-1303 and BNT324/DB-1311, in collaboration with Duality Biologics. Additionally, the company is directing its vaccine business towards selling adapted Covid-19 vaccines targeting the Omicron JN.1 variant, following updated guidelines from the World Health Organization and other regulatory agencies.

BioNTech’s CEO, Dr. Ugur Sahin, emphasized the company’s commitment to advancing its clinical development efforts and commercializing variant-adapted Covid-19 vaccines for the upcoming season. He stated, “We have started commercializing variant-adapted Covid-19 vaccines for the upcoming season while accelerating our clinical development efforts to realize the full potential of our technologies. We are making progress towards our goal of becoming a company with marketed medicines for cancer and infectious diseases.”

 PD-L1 Development biontech

Implications for the Industry

BioNTech’s decision to exit the PD-L1 development with Genmab reflects a strategic shift towards more promising areas within its portfolio. This move underscores the company’s adaptability in navigating financial challenges and optimizing its resources for higher-impact projects. The emphasis on ADCs and adapted vaccines aligns with current market needs and regulatory trends, positioning BioNTech for potential growth despite recent setbacks.

The decision to halt the PD-L1 program with Genmab highlights BioNTech’s strategic pivot amidst financial difficulties. The company is realigning its focus towards ADC development and adapting its vaccine offerings to meet evolving global health needs. This shift not only aims to stabilize BioNTech’s financial performance but also reinforces its commitment to delivering innovative treatments in oncology and infectious diseases.

 

Resource: Genmab, August 05, 2024

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