Magenta Therapeutics' Shares Gain As FDA Signs Off Blood Cancer Candidate To Enter Human Trial

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.