BioNTech SE has announced a definitive agreement to acquire Biotheus, a clinical-stage biotechnology company, for an upfront consideration of $800 million, primarily in cash, plus potential performance-based milestone payments of up to $150 million. This acquisition grants BioNTech full global rights to BNT327/PM8002, an investigational bispecific antibody targeting PD-L1 and VEGF-A, currently in late-stage clinical development. The deal is expected to close in the first quarter of 2025, pending regulatory approvals.
Strategic Rationale
The acquisition aligns with BioNTech's strategic focus on expanding its oncology portfolio and enhancing its capabilities in developing combination therapies. Prof. Ugur Sahin, M.D., Ph.D., CEO and co-founder of BioNTech, stated, "The acquisition of Biotheus builds on our successful ongoing collaboration on BNT327/PM8002 and other investigational bispecific antibodies. We believe that BNT327/PM8002 has the potential to set a new standard of care in multiple oncology indications, surpassing traditional checkpoint inhibitors."
BNT327/PM8002: A Promising Bispecific Antibody
BNT327/PM8002 has demonstrated encouraging clinical activity in various tumor types, including in patients with PD-L1-low and -negative tumors, who typically show less response to current checkpoint inhibitor treatments. Clinical trials involving over 700 patients have indicated promising efficacy and tolerability. Multiple registrational trials are planned for 2024 and 2025 to evaluate BNT327/PM8002 in combination with chemotherapy across several solid tumor indications, including small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer. Further trials will explore combinations with BioNTech’s proprietary antibody-drug conjugates (ADCs).
Expanding Capabilities and Global Footprint
Upon closing, BioNTech will gain access to Biotheus’ pipeline candidates and its in-house bispecific antibody drug conjugate capability. The acquisition will also expand BioNTech’s footprint in China, adding a local research and development hub to conduct clinical trials. Furthermore, BioNTech will acquire a state-of-the-art biologics manufacturing facility, contributing to its future global manufacturing and supply capabilities. Over 300 Biotheus employees in R&D, manufacturing, and enabling functions are expected to join the BioNTech workforce.
Planned Clinical Trials
In June 2024, an evaluation of BNT327/PM8002 in combination with BNT325/DB-1305, a Trophoblast Cell-Surface Antigen 2 (TROP2)-targeted ADC candidate developed by BioNTech in collaboration with Duality Biologics (Suzhou) Co., Ltd., was initiated as part of an ongoing Phase 1/2 clinical trial (NCT05438329). These trials underscore BioNTech's commitment to advancing transformative cancer treatments through innovative combination therapies.
