On February 3, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported the completion of the acquisition of Biotheus ("Biotheus"), a clinical-stage biotechnology company dedicated to the discovery and development of novel antibodies to address unmet medical needs of patients with oncological or inflammatory diseases (Press release, BioNTech, FEB 3, 2025, View Source [SID1234649993]). The acquisition was announced on November 2024 and builds on the successful collaboration on the late-stage clinical asset BNT327, an investigational bispecific antibody targeting PD-L1 and VEGF-A, and other bispecific antibody candidates.
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The transaction is part of BioNTech’s oncology strategy, aimed at expanding the Company’s capabilities to research, develop and commercialize BNT327 as a pan-tumor technology platform for combination therapies. With this completion of the acquisition, BioNTech obtains full global rights to BNT327 and rights to all other candidates of Biotheus’ pipeline as well as to its in-house antibody generation platform and bispecific antibody drug conjugate capability. 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.
The total consideration to acquire 100 percent of the issued share capital by Biotheus amounts to $800 million, predominantly in cash, with a small portion in BioNTech American Depositary Shares, plus additional performance-based payments of up to $150 million if certain milestones are met.
About BNT327
BNT327 is a novel investigational bispecific antibody combining two complementary, validated mechanisms in oncology into one single molecule. BNT327 combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. The blocking of VEGF-A is aimed at reversing the tumor’s immuno-suppressive effect in its microenvironment and cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), with the intention of preventing the tumor from growing and proliferating. BNT327 may be differentiated via its mechanism of action of targeting PD-L1 on the tumor cells aimed at enriching BNT327 in the tumor microenvironment and promoting localized anti-cancer activity. The co-localized blockade of the PD-(L)1 pathway and the VEGF-A driven formation of an immuno-suppressive microenvironment has been shown to deliver synergistically enhanced anti-tumor immune responses in several solid tumor types.1,2
More than 750 patients have been treated with BNT327 in clinical trials to date. Multiple clinical trials are currently ongoing evaluating BNT327 either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in various solid tumor indications. Multiple global trials are ongoing or planned to start in 2025, including three global clinical trials with registrational potential in first-line small cell lung cancer ("SCLC"), non-small cell lung cancer ("NSCLC") and triple-negative breast cancer ("TNBC"). Additional trials will explore combining BNT327 and BioNTech’s proprietary antibody-drug conjugate candidates ("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.