BioNTech SE is advancing its oncology pipeline, focusing on combination therapies and mRNA-based immunotherapies, as presented at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The company's strategy centers on addressing a broad spectrum of solid tumors with innovative approaches, including the bispecific antibody BNT327/PM8002 and personalized mRNA cancer immunotherapies.
BNT327/PM8002: A Next-Generation Immuno-Oncology Backbone
BNT327/PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, is being developed as a foundational element in BioNTech's combination therapy strategy. In December 2024, BioNTech initiated a global Phase 3 clinical trial (NCT06712355) evaluating BNT327/PM8002 plus chemotherapy versus atezolizumab plus chemotherapy in first-line extensive-stage small cell lung cancer (ES-SCLC). Another global randomized Phase 2/3 clinical trial (NCT06712316) was also initiated in December 2024, assessing BNT327/PM8002 plus chemotherapy compared to pembrolizumab and chemotherapy in first-line non-small cell lung cancer (NSCLC).
A Phase 3 clinical trial evaluating BNT327/PM8002 in first-line triple-negative breast cancer (TNBC) is expected to begin in 2025. Furthermore, BioNTech plans to initiate additional clinical trials exploring novel combinations of BNT327/PM8002 with antibody-drug conjugates (ADCs) such as BNT323/DB-1303 (trastuzumab pamirtecan), BNT324/DB-1311, and BNT326/YL202 in 2025.
Clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating BNT327/PM8002 plus BNT325/DB-1305 in multiple solid tumors, and from Phase 2 dose optimization trials in advanced TNBC (NCT06449222) and first-line SCLC (NCT06449209), are anticipated in 2025.
mRNA Cancer Immunotherapy: Autogene Cevumeran
BioNTech is also advancing its mRNA cancer immunotherapy portfolio. Autogene cevumeran (BNT122/RO7198457), an individualized neoantigen-specific immunotherapy (iNeST), is being developed in collaboration with Genentech. In December 2024, the first patient was treated in a global randomized Phase 2 clinical trial (IMCODE004) (NCT06534983) evaluating autogene cevumeran in combination with nivolumab compared to nivolumab alone in high-risk muscle-invasive urothelial carcinoma (MIUC).
Interim data from an ongoing global randomized Phase 2 clinical trial (NCT04486378) evaluating autogene cevumeran compared to watchful waiting in adjuvant ctDNA+ stage II (high risk) / stage III colorectal cancer (CRC) are expected in late 2025 or 2026.
BNT323/DB-1303: HER2-Targeted ADC
BNT323/DB-1303 (trastuzumab pamirtecan), a HER2-targeted ADC being developed with Duality Biologics, is also progressing. Clinical data from an ongoing Phase 1/2a trial (NCT05150691) evaluating BNT323/DB-1303 in HER2-expressing advanced endometrial cancer are expected in 2025. BioNTech is preparing a potential Biologics License Application (BLA) submission for BNT323/DB-1303 as a second-line or subsequent therapy in HER2-expressing advanced endometrial cancer in 2025 and plans to initiate a global Phase 3 confirmatory clinical trial (NCT06340568) in advanced endometrial cancer in 2025.
"We aim to develop BioNTech into a global immunotherapy powerhouse with the potential to improve the standard of care with innovative oncology products and prophylactic vaccines against infectious diseases," said Prof. Ugur Sahin, M.D., Co-Founder and Chief Executive Officer of BioNTech. "2025 is an important year, with data updates expected across both pillars and additional global clinical trial starts planned to generate evidence on our combination treatment concepts."
