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
Project | Company | Trial details | Other indication(s) |
---|---|---|---|
Mezagitamab | Takeda | Ph2 toplined positive Mar 2024; ph3 to start FY 2024 (by Mar 2025) | Development stopped in MM in 2020 |
CM313 | Keymed Biosciences | China ph2* uncontrolled trial, data at ASH 2023; China ph2* placebo-controlled trial completes Jan 2026 | China ph1/2 in MM |
Darzalex | J&J/Genmab | Ph2 Dart* completed Jan 2024; safety run-in data (3pts) at EHA 2022 | Approved in MM |
Sarclisa | Sanofi | Ph2* uncontrolled trial completes Jun 2026 | Approved in MM |
Note: *investigator-sponsored trial. Source: OncologyPipeline.
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