- The FDA has signed off Magenta Therapeutics Inc's MGTA IND application for MGTA-117.
- Related Content: Magenta Therapeutics Stock Drops As FDA Issues Clinical Hold On Blood Cancer Candidate IND.
- The Company expects to open the Phase 1/2 trial in Q4 2021 to evaluate its MGTA-117 antibody-drug conjugate (ADC) targeted conditioning program.
- The Phase 1/2 trial with single-dose escalating cohorts will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MGTA-117 as monotherapy in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients.
- Magenta 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.
- In addition, Magenta has planned gene therapy trial collaborations with Avrobio Inc AVRO and Beam Therapeutics Inc BEAM to evaluate MGTA-117 for conditioning gene therapy patients without using non-selective busulfan or other toxic chemotherapies.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: MGTA shares are up 9.95% at $6.74 during the market session on the last check Wednesday.
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