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Flotetuzumab (previously known as MGD006) is a humanized, investigational DART® molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on cancer cells in a wide range of hematological malignancies including acute myeloid leukemia (AML) . The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on target cells. AML is thought to arise in, and be perpetuated by, a small population of leukemic stem cells (LSCs) that generally resist conventional chemotherapeutic agents. LSCs are characterized by high levels of CD123 expression that is low or absent in the corresponding hematopoietic progenitors and stem cell populations in normal human bone marrow.
MacroGenics is conducting a single-arm, registration-enabling Phase 1/2 clinical study (NCT02152956) to evaluate flotetuzumab in up to 200 patients with primary induction failure/early relapse (PIF/ER) AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML.
MacroGenics retains global rights to flotetuzumab.
Relevant publications and presentations can be found at https://www.macrogenics.com/publications/
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.