BioNTech SE Strikes Deal to Acquire Biotheus

Image Credit: Adobe Stock Images/Papisut

BioNTech SE has signed a definitive agreement to acquire Biotheus, a clinical-stage biotech company, with the goal of enhancing its oncology strategy. The acquisition includes access to BNT327/PM8002, a bispecific antibody that targets PD-L1 and VEGF-A, while also showing promise in treating PD-L1-low and -negative tumors that often resist checkpoint inhibitors. BioNTech added that over 700 patients have been treated with the bispecific antibody, which demonstrated encouraging efficacy and tolerability across various cancers.¹

“The acquisition of Biotheus builds on our successful ongoing collaboration on BNT327/PM8002 and other investigational bispecific antibodies,” said Ugur Sahin, MD, PhD, CEO, co-founder, BioNTech, in a press release. "We believe that BNT327/PM8002 has the potential to set a new standard of care in multiple oncology indications, surpassing traditional checkpoint inhibitors. We are committed to advancing its research and development in combination with our investigational mRNA vaccines, targeted therapies, and immunomodulators with the aim of enhancing outcomes for patients with solid tumors."

Several registrational trials for BNT327/PM8002 are planned to start between now and next year, evaluating the treatment plus chemotherapy in various solid tumor indications, such as in patients with small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer. Further trials are expected to explore combining BNT327/PM8002 and BioNTech’s proprietary antibody-drug conjugates (ADCs), amid this year’s evaluation of BNT327/PM8002 in combination with BNT325/DB-1305, a trophoblast cell-surface antigen 2-targeted ADC as part of an ongoing phase I/II clinical trial.

Under terms of the deal, Biotheus shareholders will receive an upfront payment of $800 million, mainly in cash, with a small portion in American depositary shares to acquire 100% of the issued share capital, subject to customary purchase price adjustments, plus additional performance-based contingent payments of up to $150 million if certain milestones are met. The transaction is expected to close in the first quarter of next year, subject to the satisfaction of customary closing conditions, including regulatory approvals.

According to BioNTech, BNT327/PM8002’s checkpoint inhibition is aimed at restoring the ability of T cells to recognize and destroy tumor cells while targeting VEGF-A. The treatment is aimed at inhibiting tumor angiogenesis, which cuts off the blood and oxygen supply that feeds tumor cells and thus prevents the tumor from growing and proliferating. Additionally, they stated that the combined blockade of the PD-L1 pathway and the VEGF-A driven angiogenesis has been shown to deliver synergistically enhanced anti-tumor immune responses in several solid tumor types.¹

According to a study published in the National Library of Medicine, PD-L1 expression could predict mammalian target of rapamycin (mTOR) activity and rapamycin-sensitive tumor growth. Further, that autophagy reduction in cancer cells with elevated mTOR activity and low autophagic activity related to PD-L1 expression could be a catastrophic cell event, exploited in future combination therapy treatments.²

“We are thrilled to deepen our bond with BioNTech. We share the goal of advancing the development of BNT327/PM8002 for future combination therapies in the fight against cancer,” said Xiaolin Liu, president, CEO, co-founder, Biotheus, in the press release. “We believe that BNT327/PM8002 holds significant potential across various tumor indications, and we have an exciting pipeline of innovative investigational assets under development including an antibody discovery and development platform. As we move forward, we are committed to leveraging our strengths with the aim of advancing transformative cancer treatments and enhance our ability to develop treatments for patients in need.”

References

1. BioNTech to Acquire Biotheus to Boost Oncology Strategy. BioNTech. November 13, 2024. Accessed November 13, 2024. https://investors.biontech.de/news-releases/news-release-details/biontech-acquire-biotheus-boost-oncology-strategy

2. PD-L1 is a diverse molecule regulating both tumor-intrinsic signaling and adaptive immunosuppression. NIH. Accessed November 13, 2024. https://pmc.ncbi.nlm.nih.gov/articles/PMC5323246/#:~:text=PD%2DL1%20expression%20could%20predict,in%20future%20combination%20therapy%20treatments.