BioNTech Bolsters Oncology Strategy with Biotheus Acquisition

BioNTech SE (Nasdaq: BNTX), a global leader in next-generation immunotherapy, has completed its acquisition of Biotheus, a clinical-stage biotechnology company dedicated to the discovery and development of novel antibodies for oncology and inflammatory diseases. The acquisition, announced in November 2024, strengthens BioNTech's oncology strategy and expands its capabilities in developing, manufacturing, and commercializing next-generation bispecific antibodies and novel treatment combinations.



With the acquisition, BioNTech gains full global rights to BNT327/PM8002, an investigational PD-L1 x VEGF-A bispecific antibody with potential to replace current checkpoint inhibitor standard of care treatments for solid tumors. BNT327/PM8002 has demonstrated encouraging efficacy and tolerability in patients across various tumor types, with more than 700 patients treated in clinical trials to date. The asset has shown positive safety profiles and antitumor activity in phase 2 trials in China, enriching anti-VEGF activity into the tumor microenvironment.

BioNTech and Biotheus plan to initiate multiple registrational trials with BNT327/PM8002 in late 2024 and 2025, evaluating it in combination with chemotherapy in various solid tumor indications. Further clinical trials are planned to explore combining BNT327/PM8002 with BioNTech's proprietary antibody-drug conjugates (ADCs). If successfully developed and approved, BioNTech aims to use this bispecific antibody candidate as a next-generation immuno-oncology (IO) backbone in combination with other treatment modalities targeting a broad range of cancer indications.

The acquisition also adds Biotheus' pipeline of ten programs at various stages of clinical development to BioNTech's portfolio, strengthening its pipeline of novel treatment combinations targeting different oncogenic pathways in various solid tumor indications. Additionally, Biotheus will operate as a new indirect Chinese subsidiary of BioNTech, adding a local research and development hub and an advanced biologics manufacturing facility to the Company's network. This will enhance BioNTech's ability to develop and manufacture treatments for patients in need.



BioNTech paid $800 million to acquire 100 percent of the issued share capital of Biotheus, predominantly in cash, with a small portion in BioNTech American Depositary Shares. The company is also eligible to receive additional performance-based payments of up to $150 million if certain milestones are met. This strategic acquisition builds on BioNTech's successful ongoing collaboration with Biotheus on BNT327/PM8002 and other investigational bispecific antibodies, further strengthening its position in the bispecific antibody market.

In conclusion, the acquisition of Biotheus by BioNTech enhances the latter's oncology strategy and capabilities by providing full global rights to BNT327/PM8002, expanding its manufacturing capabilities and supply chain resilience, and strengthening its pipeline of novel treatment combinations. This strategic move positions BioNTech to advance its research and development in combination with its investigational mRNA vaccines, targeted therapies, and immunomodulators, ultimately enhancing outcomes for patients with solid tumors.