Bispecific antibodies will start maturing after 2021 with estimated sales in oncology of $6bn by 2025

The clinical success of Amgen’s Blincyto has amplified the intensive pace of development for bispecific antibodies in oncology. According to GlobalData’s drugs database, there are 106 bispecific antibody molecules – with various targets – currently in the pipeline. Furthermore, there are 263 ongoing/planning to enroll clinical trials involving a bispecific antibody.

Sakis Paliouras, PhD, Oncology Analyst at GlobalData, comments: “Blincyto has revolutionized the treatment of acute lymphocytic leukemia (ALL). This class of immuno-oncology drugs is typically used in the same context as CAR-T cells, but has the inherent advantage of off-the-shelf delivery while promising a more precisely controlled safety profile. Major players such as Amgen, Roche, Regeneron and Johnson & Johnson are now invested in the development of bispecific antibodies for various cancers, with most of their ongoing trials involving blood cancers.”

Most bispecific antibodies are in an early phase of development, with 70 agents in Phase I compared to 36 in Phase II. This highlights the relative lack of maturity for this technology, however, it has great market potential. GlobalData estimates that the bispecific antibody sales in oncology will reach $6bn by 2025.”

Of the 106 bispecific antibody agents that are currently in clinical development, 45 are purposed primarily for blood cancers and the rest for solid tumors – mainly gastrointestinal and lung cancers. The most prominent targets for bispecific antibodies are CD19, CD20 and BCMA in blood malignancies, and EGFR and HER2 in solid tumors. However, some agents may be intended for multiple cancer types. For example, mosunetuzumab has four ongoing clinical trials for various B-cell malignancies.

Furthermore, more than half of the 106 agents are bispecific T-cell engagers (BiTEs), binding the CD3 antigen in T-cells in order to promote an anti-tumor immune response.

Paliouras concludes: “Blincyto remains the only bispecific antibody approved for an oncology indication. While the field is still immature, GlobalData expects this to change in 2021 with a potential market entry of Roche’s mosunetuzumab for B-cell malignancies and multiple other new agents with potential approval in 2022.”

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