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Magenta Therapeutics Gets IND Clearance for MGTA-117

By Chris Wack

 

Magenta Therapeutics Inc. said its Investigational New Drug application for MGTA-117 is active with the U.S. Food and Drug Administration.

The biotechnology company said it expects to open the Phase 1/2 clinical trial in the fourth quarter of 2021 to evaluate its MGTA-117 antibody-drug conjugate targeted conditioning program.

The Phase 1/2 clinical trial with single-dose escalating cohorts will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MGTA-117 as a single agent in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome patients.

Magenta said it will continue to engage with the FDA to transition the trial to the intended primary target population of hematopoietic stem cell transplant-eligible AML and MDS patients.

The company has also planned gene therapy clinical trial collaborations with Avrobio and Beam Therapeutics to evaluate the potential utility of MGTA-117 for conditioning gene therapy patients without the use of non-selective busulfan or other toxic chemotherapies.

Magenta shares were up 5% to $6.40 in premarket trading.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

September 15, 2021 08:52 ET (12:52 GMT)

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