AML Trial Paused by Patient Death
Wednesday, Magenta Therapeutics halted the Phase I/II dose-escalation trial of their acute myeloid leukemia (AML) treatment due to the death of a patient.
The mortality happened in Cohort 3 of the experiment, where participants were administered MGTA-117 at a dosage of 0.08 mg/kg.
The patient in issue experienced a grade 5 significant adverse event that included cardiac arrest and respiratory failure and ended in death. This incident was thought to be possibly connected to the study medication.
Magenta filed a Suspected Unexpected Serious Adverse Reaction report with the FDA on the occurrence. The choice to suspend the research is voluntary and in agreement with the safety cohort review committee’s suggestions.
The business is presently reviewing all of the data and determining how to best move forward with the development of MGTA-117.
In Wednesday’s post-market trade, shares of Magenta fell 25%.
The most developed oncology candidate from Magenta, MGTA-117, is an alpha-amanitin-loaded antibody-drug combination that targets the CD117 receptor.
Hematopoietic stem cells, progenitor cells, and malignant blast cells all express the protein CD117. The very poisonous chemical -Amanitin, which is obtained from the death-cap mushroom, is also known to destroy cancer cells.
MGTA-117 functions as a targeted conditioning therapy and selectively depletes CD117-bearing cells in the blood or bone marrow before patients get gene treatments or receive stem cell transplants by combining these two components into a single molecule. MGTA-117 thus lessens or replaces the requirement for chemotherapy.
Deaths of Patients Impact AML Drug Development
A roadblock has lately arisen for numerous biopharmaceutical firms in their search for efficient and novel AML therapies.
The FDA placed the Phase I dose-escalation AML trial of Foghorn Therapeutics, another Massachusetts-based business, on full clinical hold in August 2022 as a result of a patient fatality.
FHD-286, a BRG1/BRM inhibitor, was tested by Foghorn. The deadly differentiation syndrome was the cause of the death.
After a patient in Phase I/IIa dose-escalation TakeAim Leukemia trial passed away from several problems, including rhabdomyolysis, a recognized dose-limiting hazard of Emavusertib, in April 2022, Curis’ oral Emavusertib was partially put on hold. The FDA asked Curis for further safety and effectiveness information.
In November 2021, the FDA partially halted Kura Oncology’s Phase Ib AML study as a result of a patient passing away from catastrophic differentiation syndrome. KO-539, an experimental oral inhibitor of the Menin-KMT2A/MLL protein-protein interaction, is Kura’s AML hopeful.
In January 2022, the FDA released KO-539 from its embargo. The development of the Foghorn and Curis candidates is still on hold.