Bristol Myers Squibb, BioNTech Partner to Develop Next-Gen Bispecific Antibody for Solid Tumors

Bristol Myers Squibb (BMS) and BioNTech have announced a global strategic partnership to co-develop and co-commercialize BNT327, BioNTech’s bispecific antibody candidate targeting multiple solid tumor types. BNT327, which targets PD-L1 and VEGF-A, is currently in advanced clinical trials, including global Phase III trials for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC), with a trial in triple-negative breast cancer (TNBC) expected to begin by the end of 2025. Preliminary data indicate that combining these two established targets in a single molecule could offer synergistic benefits across several tumor types.

What Makes BNT327 a Potential Game-Changer in Oncology?

Under terms of the deal, BMS will make an upfront payment of $1.5 billion to BioNTech and commit an additional $2 billion in non-contingent payments through 2028, with potential milestone payments reaching up to $7.6 billion. Development, manufacturing, and global profits will be equally shared.¹

"We believe BNT327 has the potential to become a foundational immuno-oncology backbone, moving beyond single-mechanism checkpoint inhibitors and expanding into multiple solid-tumor indications,” said Ugur Sahin, MD, CEO, co-founder, BioNTech, in a press release. “Our collaboration with BMS, a pioneering leader in immuno-oncology, aims to accelerate and broadly expand BNT327’s development to fully realize its potential. Our focus remains on advancing high-impact, pan-tumor programs and combination strategies in oncology, with BNT327 complementing our antibody-drug conjugate programs and mRNA-based immunotherapies. We are dedicated to delivering truly transformative options for patients in need."

Bispecific Antibodies Gain Momentum in Pharma

The deal comes amid an increased interest in bispecific antibodies that simultaneously inhibit immune checkpoints and tumor angiogenesis. Last month, Pfizer announced a $6 million agreement with 3SBio to develop, manufacture, and commercialize SSGJ-707, an additional bispecific antibody targeting PD-1 and VEGF pathways. According to Pfizer, the treatment has shown promise in NSCLC, metastatic colorectal cancer, and gynecological malignancies.

Recent Acquisitions and Competitive Landscape

In November 2024, BioNTech acquired Biotheus for $800 million. Under terms of that deal, BioNTech obtained the rights to BNT327/PM8002, a bispecific antibody that also targets PD-L1 and VEGF.

In clinical trial results announced in April, Akeso's PD-1/VEGF bispecific candidate, ivonescimab, demonstrated superior efficacy compared to tislelizumab plus chemotherapy in the first-line treatment of advanced squamous NSCLC in both PD-L1-positive and PD-L1-negative patient populations.²

Clinical Trial Pipeline and Future Outlook

“Our deep experience and expertise in advancing and delivering groundbreaking immuno-oncology medicines positions BMS well to collaboratively realize the potential of BNT327, an asset with significant potential for transforming the standard of care for patients with solid tumors,” said Christopher Boerner, PhD, board chair, CEO, BMS, in the press release. “The science behind BNT327 and its leading clinical position in multiple hard-to-treat tumor types, further bolsters our pursuit of novel mechanisms and multiple modalities in oncology and enhances our growth trajectory. We are impressed by the innovation that BioNTech has achieved to date, and we look forward to partnering to accelerate existing clinical trials and time to market, while expanding the number of potential indications.”

According to BMS, over 1,000 patients have received BNT327 across clinical trials to date. More than 20 studies are either underway or planned to assess BNT327 as a standalone therapy or in combination with other treatments targeting diverse oncogenic pathways across more than 10 solid tumor types. Further studies are expected to investigate the potential of combining BNT327 with BioNTech’s antibody-drug conjugates.¹

References

1. BioNTech and Bristol Myers Squibb Announce Global Strategic Partnership to Co-Develop and Co-Commercialize Next-generation Bispecific Antibody Candidate BNT327 Broadly for Multiple Solid Tumor Types. BMS. June 2, 2025. Accessed June 2, 2025. https://news.bms.com/news/corporate-financial/2025/BioNTech-and-Bristol-Myers-Squibb-Announce-Global-Strategic-Partnership-to-Co-Develop-and-Co-Commercialize-Next-generation-Bispecific-Antibody-Candidate-BNT327-Broadly-for-Multiple-Solid-Tumor-Types/default.aspx

2. Pfizer, 3SBio Forge Licensing Pact for SSGJ-707 to Target Lung, Colorectal, and Gynecologic Cancers. PharmExec. May 20, 2025. Accessed June 2, 2025. https://www.pharmexec.com/view/pfizer-3sbio-forge-licensing-pact-ssgj-707-target-lung-colorectal-gynecologic-cancers