Bispecific Antibodies in Solid Tumour Immunotherapy

Executive Summary

Bispecific antibodies (BsAbs) are transforming the landscape of solid tumour treatment. With over 574 active clinical trials and several regulatory approvals, BsAbs are gaining rapid momentum. This Rugia BioIntel Brief explores key mechanisms, target combinations, funding patterns, and competitive insights.

Scientific Context

BsAbs are engineered to bind two distinct targets, enabling novel mechanisms of tumor targeting, immune cell recruitment, and dual checkpoint inhibition. This dual-binding strategy addresses tumour heterogeneity and enhances therapeutic specificity.

Mechanisms of Action

Key mechanisms include T-cell engagers (e.g. CD3-based), dual immune checkpoint inhibitors, dual tumour antigen blockers, tumour-localised immune agonists, and NK/myeloid cell engagers.

Competitive Landscape

Major players include Roche, Genmab, Immunocore, Zymeworks, and Akeso. Strategic partnerships and biotech innovation are fueling diversification of the BsAb development pipeline.

In 2025, Akeso is the leader with Ivonescimab (PD-1 × VEGF), already approved in China for Non-Small Cell Lung Cancer, providing early revenue streams and clinical validation. AP Biosciences, though pre-approval, raised $38 million in Series D to advance AP505 (PD-L1 × VEGF), aiming to exploit dual checkpoint and angiogenesis blockade. BioNTech’s BNT327 targets PD-L1 and the co-stimulatory receptor 4-1BB, leveraging their immuno-oncology platform to potentially enhance T-cell activation. These strategies illustrate diverging risk profiles: Akeso capitalising on market lead, while AP Biosciences and BioNTech pursue differentiated mechanisms with significant upside in solid tumours.

Funding and Strategy

T-cell engagers receive the majority of funding. Dual-antigen and immune-modulating BsAbs are rapidly rising areas, attracting venture interest. Strategic collaborations and novel delivery formats offer unique value propositions. Overall, the bispecific antibody market is projected to quadruple by 2030.

Figure 1: BsAbs in clinical trials by development phase. Source: ClinicalTrials.gov (2025), Rugia Analysis.

References

·       ClinicalTrials.gov (2025) Search results for Bispecific antibody clinical trials.

·       FDA Drug Trials Snapshots, 2024

·       BioCentury BCIQ, Oncology Reports Q1 2024

·       EvaluatePharma Oncology Intelligence, 2024

·       Company reports: Genmab, Zymeworks, Immunocore, Akeso Biopharma

·       PitchBook Data on Biotech Deal Flow, 2020–2024

·       Ivonescimab Injection Approved for Marketing by China NMPA. National Medical Products Administration (NMPA), February 19, 2025

·       AP Biosciences Milestone. AP Biosciences Official Website, 2024

·       BioNTech Completes Acquisition of Biotheus. Biotheus News, February 2025.