An Investor’s Guide to Bispecific Antibodies
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This report provides a detailed overview of bispecific development. The FDA’s recent approval of Rybrevant marked the third US approval of a bispecific. With multiple bispecifics entering late-stage trials, we expect the pace of approvals to accelerate. In this primer, we mention 200+ bispecific assets, highlight key upcoming catalysts, and detail recent bispecific-focused partnerships.
Bispecific antibodies are antibody structures with the ability to bind two different targets. The mechanisms of action generally fall into three categories:
The FDA’s approval of Rybrevant for the treatment of patients with metastatic NSCLC with EGFR exon 20 insertion mutations in May 2021 marked the third US approval of a bispecific asset. Blincyto and Hemlibra are also approved.
The rapid adoption demonstrates the potential of the market. Blincyto (CD3xCD19) was first approved in the US in 2014 for the treatment of B-ALL. Despite the short half-life and requirements for continuous infusion, sales were $379MM in 2020, and we project revenues growing to $400MM in 2025. Hemlibra (FVIII mimetic) was approved in 2017. Sales of Hemlibra were CHF 2.2B in 2020, and we estimate sales of CHF 5.3B in 2025.
High profile catalysts include regulatory action Faricimab (VEGFxAng2, late2021); filings for two CD3xCD20 assets, Mosunetuzumab (2H21) and Glofitamab(2022), and Tebentafusp (CD3xgp100, 2H21); pivotal trial initiations for Odronextamab (CD3xCD20, 2H21); and late-stage data updates for KN046 (PD-1xCTLA-4, 2H21), Flotetuzumab (CD3xCD123, 2H21), Elranatamab (CD3xBCMA, possibly 2022), and Zanidatamab(HER2xHER2, 2H21). We believe positive outcomes can drive up investor interest.
Strong M&A activities continue as companies seek to develop promising bispecific candidates and combine multiple approaches. Our review of the field identified 28 transactions focused on bispecific assets in the last year. We expect deal flow in the bispecific space to continue to grow.