An analysis of GlobalData’s Drugs Database reveals that there are 106 different bispecific antibodies in active clinical development for various oncology indications. Bispecific antibodies are uniquely engineered to simultaneously bind two different antigens. Their most frequent application is to engage the CD3 antigen in T-cells in order to promote antibody-dependent cell-mediated cytotoxicity (ADCC), in which case they are called bispecific T-cell engagers (BiTEs). The only current marketed bispecifics globally are Roche’s Hemlibra (emicizumab-kxwh) for hemophilia A and Amgen’s Blincyto (blinatumomab) for acute lymphocytic leukemia (ALL).
Blincyto was first approved in 2014 and has revolutionised the treatment of ALL, while simultaneously validating the concept of BiTEs. Despite ALL being a rare indication, Blincyto achieved global sales of $312M in 2019, evidencing that BiTEs have excellent market potential in other oncology indications, including room for entry to solid tumor markets. GlobalData’s Pharma Intelligence Center (IC) reveals that 70 of these agents are in Phase I trials, 36 in Phase II, and no agents in Phase III, corroborating the fact that most bispecific antibodies are still in early-phase development.
In terms of the mechanism of action, the most prominent targets for bispecific antibodies are CD19, CD20, and BCMA in blood malignancies and EGFR and HER2 in solid tumors. A number of early-phase programs are BiTEs with their second targeted antigen being undisclosed. GlobalData’s Pharma IC lists 263 trials either ongoing or planned with a bispecific antibody. Of these trials, the top 10 sponsors are depicted in Figure 1, highlighting that major players in the development of bispecifics are Amgen, Roche, and Regeneron with 19, 16, and 11 ongoing/planned trials respectively. Zymeworks, Johnson & Johnson, and Alphamab Oncology are also heavily invested in the development of bispecifics, with 10 ongoing/planned trials each.
GlobalData monitors the development of new bispecific antibodies with great interest. Some notable examples include the anti-CD20 BiTEs mosunetuzumab and glofitamab from Roche, which have the potential to build on the great success of single-agent anti-CD20 antibodies and reach even higher market share. Also, flotetuzumab by MacroGenics has the potential to make a large impact on leukemias that express the CD123 antigen. Lastly, Regeneron has an extensive portfolio of bispecifics for both solid and blood cancers, albeit in earlier phases of development. GlobalData’s Drug Sales and Consensus Forecast Database estimates that the bispecific antibody market value for the treatment of cancer will reach $6B globally by 2025.