AbbVie ditches I-Mab’s anti-CD47 monoclonal antibody lemzoparlimab
Phase 3AcquisitionLicense out/inPhase 2
AbbVie decided to exit its agreement with I-Mab to develop certain CD47 antibody compounds, including the programme’s lead drug lemzoparlimab. The move – disclosed by I-Mab in a US securities filing – comes just over a year after AbbVie halted an early-stage study of lemzoparlimab in patients with myelodysplastic syndrome (MDS) and acute myelocytic leukaemia (AML).
The terminated trial had been testing lemzoparlimab in combination with AbbVie's BCL-2 inhibitorBCL-2 inhibitor Venclexta (venetoclax) and azacitidine. I-Mab indicated at the time that the decision to stop the trial was "not based on any specific or unexpected safety concerns."
AbbVie paid $180 million upfront in 2020 as part of a collaboration potentially worth up to $1.7 billion for rights to lemzoparlimab outside of China, although the partnership was later tweaked with milestones downgraded to up to $1.3 billion. I-Mab explained that the termination of the deal, which will take effect on November 20, is based “in its entirety” on the earlier study halt, as well as a “strategic decision” by AbbVie.
CD47 space cools down
Last month, the FDA placed a partial clinical hold on trials of Gilead Sciences’ anti-CD47 antibody magrolimab in patients with AML, with an earlier partial hold affecting development in both AML and MDS. The most recent hold follows the discontinuation of the Phase III ENHANCE study of magrolimab plus azacitidine in higher-risk MDS following a planned futility analysis. Gilead acquired magrolimab as part of its purchase of Forty Seven for $4.9 billion in 2020.
Meanwhile, ALX Oncology recently decided to stop development of its CD47-blocking fusion protein evorpacept in MDS and AML. The move came after the combination of evorpacept and azacitidine failed to "substantially improve" upon azacitidine alone in the Phase I/II ASPEN-02 study for patients with MDS.
Earlier this year, I-Mab kicked off a Phase III study of lemzoparlimab in combination with azacitidine as a first-line treatment for patients with higher-risk MDS. The company said it will assess upcoming data from other investigational CD47 therapies to explore future development opportunities with lemzoparlimab.
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