BioNTech SE (Nasdaq: BNTX) has announced its third-quarter 2024 financial results and provided a corporate update, highlighting significant advancements in its oncology pipeline and the successful launch of variant-adapted COVID-19 vaccines. The company is progressing with clinical trials for its bispecific antibody candidate BNT327/PM8002 and mRNA cancer vaccine candidates, reinforcing its commitment to becoming a global multi-product immunotherapy company.
Oncology Pipeline Advancements
BioNTech's oncology pipeline is showing promise with several key developments:
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BNT327/PM8002 (PD-L1 x VEGF-A Bispecific Antibody): Two Phase 2 dose optimization trials have been initiated to evaluate BNT327/PM8002 in combination with chemotherapy for small-cell lung cancer (SCLC) and triple-negative breast cancer (TNBC). These trials aim to inform planned pivotal Phase 3 trials. Data presented at the European Society for Medical Oncology (ESMO) Congress in September 2024 showed encouraging anti-tumor activity and a manageable safety profile in patients with advanced TNBC, EGFR-mutated NSCLC, and renal cell carcinoma (RCC).
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Autogene Cevumeran (BNT122/RO7198457) – Individualized mRNA Cancer Vaccine: A Phase 2 clinical trial is on track to evaluate autogene cevumeran as an adjuvant treatment in patients with high-risk muscle-invasive urothelial cancer (MIUC). This individualized neoantigen-specific immunotherapy (iNeST) is being developed in collaboration with Genentech, a member of the Roche Group.
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BNT113 (mRNA Cancer Vaccine): Based on BioNTech’s FixVac platform, BNT113 encodes Human Papilloma Virus 16 (HPV16) antigens. An exploratory analysis of antitumor activity and immunogenicity from the safety run-in of the AHEAD-MERIT trial was presented at ESMO, supporting the tolerability and clinical activity of BNT113 in combination with pembrolizumab in patients with unresectable, recurrent or metastatic, PD-L1+, HPV16+ head and neck squamous cell carcinoma.
COVID-19 Vaccine and Financial Performance
BioNTech and Pfizer successfully launched their variant-adapted COVID-19 vaccines for the 2024/2025 vaccination season. The updated vaccines received approvals from the European Commission (EC) and the U.S. Food and Drug Administration (FDA), and shipments commenced shortly after approval.
For the third quarter of 2024, BioNTech reported revenues of €1.2 billion, a net profit of €198.1 million, and diluted earnings per share of €0.81. The company ended the quarter with €17.8 billion in cash and cash equivalents plus security investments. BioNTech expects to be at the low end of its full-year 2024 revenue guidance range (€2.5-3.1 billion) and re-confirmed its guidance for planned full-year 2024 R&D expenses (€2.4-2.6 billion).
BNT316/ONC-392 (gotistobart) Clinical Hold
In October 2024, the FDA placed a partial clinical hold on the Phase 3 trial (PRESERVE-003) of BNT316/ONC-392, an anti-CTLA-4 monoclonal antibody candidate, due to varying results between patient populations. Enrollment of new patients has been paused, but patients already enrolled will continue to receive treatment. Trials evaluating BNT316/ONC-392 in other indications remain unaffected.
Looking Ahead
BioNTech remains focused on advancing its late-stage oncology product candidates toward potential registration. The company plans to present data from the Phase 2 trial of BNT111 in combination with cemiplimab at an upcoming medical conference in 2025. Additionally, interim data from the Phase 2 clinical trial in stage II (high-risk) and III circulating tumor DNA+ (ctDNA) adjuvant CRC is projected for late 2025 or 2026.
