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Takeda ploughs a lonely CD38 furrow

Anti-CD38 MAbs are best known as multiple myeloma therapies, but Takeda is trying something different. In 2020 it abandoned work on its contender, mezagitamab, in MM to focus on rare diseases, and has just posted a phase 2 win in primary immune thrombocytopenia (ITP). The company, which is already planning a phase 3 trial, isn’t giving detailed data for now, only saying that all three doses tested produced higher platelet responses than placebo, and that responses were dose dependent. A look at the pipeline shows the Japanese group to be well ahead with CD38 in ITP; investigator-sponsored mid-stage studies of Johnson & Johnson/Genmab’s megablockbuster Darazalex and Sanofi’s Sarclisa are ongoing, but the disorder is clearly not a priority for these developers. CM313, being developed by China’s Keymed Biosciences, is also in academia-led ITP trials, but that group’s focus seems to be MM. ITP is a blood disorder characterised by the destruction of platelets, often caused by autoantibodies. It’s thought that by targeting antibody-producing plasma cells CD38 MAbs could combat the disease. Existing therapies for ITP include steroids and intravenous gamma globulin; last year a subcutaneous formulation of Argenx’s Vyvgart flunked a pivotal trial in ITP.

 

Anti-CD38 MABs in clinical trials for ITP

ProjectCompanyTrial detailsOther indication(s)
MezagitamabTakedaPh2 toplined positive Mar 2024; ph3 to start FY 2024 (by Mar 2025)Development stopped in MM in 2020
CM313Keymed BiosciencesChina ph2* uncontrolled trial, data at ASH 2023; China ph2* placebo-controlled trial completes Jan 2026China ph1/2 in MM
DarzalexJ&J/GenmabPh2 Dart* completed Jan 2024; safety run-in data (3pts) at EHA 2022Approved in MM
SarclisaSanofiPh2* uncontrolled trial completes Jun 2026Approved in MM

Note: *investigator-sponsored trial. Source: OncologyPipeline.