Date: 2017-07-17
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2017 Congress
Company: Macrogenics (USA - Md) Servier (France)
Product: flotetuzumab - MGD006
Action
mechanism:
- bispecific DART. MGD006 is a humanized DART molecule that recognizes both CD123 and CD3. The molecule was designed to redirect T cells via their CD3 component to kill CD123-expressing cells, as shown pre-clinically. CD123, the Interleukin-3 receptor alpha chain, has been reported to be overexpressed on malignant cells in a wide range of hematological malignancies including AML and myelodysplastic syndrome (MDS). AML and MDS are 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.
- Flotetuzumab (also known as MGD006 and S80880) is a clinical-stage 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 AML and MDS. 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 the target cancer cells.
Flotetuzumab is currently being evaluated in the U.S. and Europe in a Phase 1 dose-escalation study designed to assess the safety and tolerability of the molecule in patients with relapsed/refractory AML or MDS. MacroGenics retains full development and commercialization rights to flotetuzumab in the U.S., Canada, Mexico, Japan, South Korea and India. Servier participates in the development and has rights to flotetuzumab in all other countries. The U.S. Food and Drug Administration has granted orphan drug designation to flotetuzumab for the investigational treatment of
- MacroGenics has development and commercialization rights to MGD006 in the U.S., Canada, Mexico, Japan, South Korea and India; MacroGenics' partner, Servier, has rights to MGD006 in all other countries.
Disease: relapsed or refractory acute myeloid leukemia
Therapeutic
area: Cancer - Oncology
Country: France, Germany, Italy, Netherlands, USA
Trial
details:
- The Phase 1 dose-escalation study is designed to assess the safety and tolerability of MGD006 in patients with relapsed or refractory acute myeloid leukemia. The study has been initiated at Washington University School of Medicine in St. Louis with John Di Persio, M.D., Ph.D. serving as the lead investigator. In addition to the primary safety endpoint, secondary endpoints of pharmacokinetics and activity will be evaluated, as will a number of translational endpoints examining the immunobiology of MGD006. (NCT02152956)
Latest
news:
- • On July 17, 2017, MacroGenics announced that data from the ongoing Phase 1 clinical study of flotetuzumab has been accepted for an oral presentation at the European Society for Medical Oncology Annual Congress, ESMO 2017, taking place in Madrid, Spain from September 8-12, 2017. MacroGenics will present the following oral presentation:
Title: Interim Results from a Phase 1 First-in-Human study of flotetuzumab, a CD123 x CD3 bispecific DART molecule, in AML/MDS.
- • On June 19, 2014, MacroGenics announced that a first patient received drug in a Phase 1 study of MGD006 in relapsed or refractory acute myeloid leukemia (AML). This study marks the first clinical trial of a DART product candidate.
Is
general: Yes
