BioNTech pivots focus to ADCs, CAR-Ts to drive 2024 growth

Headquartered in Mainz, Germany, BioNTech gained fame with Pfizer through their breakthrough COVID-19 vaccine, BNT162b2 (Comirnaty), the first mRNA vaccine approved for emergency use in December 2020.

The total revenue reported by the firm for 2023 was €3.8 billion ($4 billion), compared to €17.3 billion ($18 billion) year-on-year. While decreased COVID vaccine demand was the major driver, the firm noted a revenue hit of €906 million ($981 million) due to inventory write-downs by Pfizer.

However, the firm says strengthening its oncological pipeline will buttress its footing by the end of 2024. “The field of oncology is currently undergoing a significant shift away from traditional chemotherapy therapy towards combination therapies,” said Ugur Sahin, CEO of BioNTech, during its financial call.

“This shift leverages the power of immuno-oncology [IO] and antibody-drug conjugates [ADC] to potentially transform advanced cancers into manageable conditions. As we reflect on the achievements of 2023, we can proudly say that we have accelerated our IO and ADC programs, by not only starting new trials, but also successfully recruiting over 2,000 patients into our clinical trials across various indications.”

Previously, the firm has invested in cell therapies, antibodies, and in April 2023 the firm agreed to pay China-based biotech company DualityBio $170 million upfront to develop, manufacture, and commercialize two ADC assets globally.

Additionally, the firm has partnered with Biotheus, Medilink and OncoC4 to enhance its clinical oncology portfolio by integrating ADCs and immuno-modulatory programs.

Moreover, he also cited a move into cell therapy, with BioNTech’s partnership with Autolus inked earlier this year. “On the collaboration front, by announcing a strategic alliance with Autolus aimed at advancing both companies autologous CAR-T cell programs towards commercialization. With this collaboration, we will support the development and commercialization of Autolus CAR-T cell therapy candidate, obe-cel and retain options to participate in its Auto-122 and Auto-6 NG programs.”

Through this agreement, BioNTech has the option to use Autolus’ commercial and cell therapy manufacturing infrastructure, boosting its plans to extend the development of BNT-211 to additional Claudin-6 positive tumor types, said the CEO.

Reassuring stakeholders of the firm’s comeback, the CEO said, “Over the course of 2024, we aim to advance and prioritize additional product candidates to late-stage development. We expect to have 10 or more potential registrational trials running.”

The firm confirmed its plans to launch its first oncology pipeline in 2026 and ten indication approvals by 2030 as part of its strategy “to develop combinatorial and synergistic therapeutic approaches.”