Daily Newsletter

06 August 2024

Daily Newsletter

06 August 2024

BioNTech exits PD-L1 development with Genmab as Q2 revenues drop

BioNTech has given Genmab full control of their joint PD-L1 therapy programme, as it recovers from Q2 losses.

Akosua Mireku August 05 2024

BioNTech has parted ways with Genmab for the joint development of their cancer programmed-cell death 1 ligand-1 (PD-L1) therapy, acasunlimab (BNT311/GEN1046), as it reports major Q2 losses.

The German pharmaceutical giant reported a net loss of €807.8m ($885m) for Q2, in a 5 August press release. The company also shared that its Q2 revenue has dropped to €128.7m, compared to €167.7m in 2023. BioNTech cited the drop in global Covid-19 vaccine sales as the reason for the drop in revenue. However, despite the losses, the company maintained that its full expected revenue for 2024 should still be on track for €2.5bn-€3.1bn.

The financial report also revealed BioNTech’s plans to quit the development of acasunlimab (BNT311/GEN1046), leaving the programme for Genmab to commandeer. BioNTech has chosen not to participate in the drug’s Phase III development despite the release of positive interim Phase II trial data.

The bispecific antibody is currently in a Phase II randomised study (NCT05117242), investigating its use for non-small cell lung cancer. Interim data from the trial demonstrated that the drug showed a 12-month overall survival rate of 69% and a median overall survival of 17.5 months in combination with MSD’s Keytruda (pembrolizumab). Genmab will present updated data from the study at the World Conference on Lung Cancer being held on 7 to 10 September

The split arrives after BioNTech and Genmab expanded their clinical collaboration in 2022 to research, develop and commercialise novel monospecific antibody candidates for various cancer indications. The companies have not shared plans to end the joint development of their other cancer assets, including BNT-313 and BNT-312.

BioNTech shared that it would continue to focus on developing its antibody-drug conjugate (ADC) pipeline, including BNT323/DB-1303 and BNT324/DB-1311, both being shared assets with Duality Biologics.

Aside from its cancer pipeline, the company has directed its vaccine business plans towards selling adapted Covid-19 vaccines to meet the need for options targeting the Omicron JN.1 variant. This shift arrived after the World Health Organization, US Food and Drug Administration, and other regulatory agencies adapted their guidelines this year to recommend Omicron JN.1-adapted monovalent Covid-19 vaccine.

In the company’s Q2 financial earnings report, BioNTech’s CEO Dr Ugur Sahin said: “We have started commercialising variant-adapted Covid-19 vaccines for the upcoming season while accelerating our clinical development efforts to realise 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.”

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