FDA Accepts Application for New Engineered Toxin Body Drug by Takeda Oncology and Molecular Templates

Molecular Templates and Takeda Oncology are teaming up to develop a new class of targeted biologic therapeutics for myeloma patients. The FDA has now accepted the application for TAK-169, an Engineered Toxin Body (EBT) targeting CD38. Together, they plan to conduce a Phase I trial for relapsed/refractory myeloma patients. 

According to Eric Pooma, PhD, CEO and CSO of Molecular Templates, the new CD38 drug could help overcome resistance to existing CD38 targeted therapies (think daratumumab). 

This new drug, TAK-169, forces a toxic payload to the internal structure of the CD38 in myeloma cells and expands the universe of extracellular receptors that can be targeted for direct cell killing. These EBTs self-navigate to the liquid inside of cells and have been de-immunized to reduce an immune response against them, improving safety.

TAK-169 is active in the presence of daratumumab and could potentially be combined with other CD38 monoclonal antibodies. Takeda Oncology and Molecular Templates are partnering on development costs. Myeloma patients look forward to this opening in the Phase I trial.

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