In June, the IND was filed to initiate a Phase 1/2 trial of MGTA-117 in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
The FDA has asked Magenta to develop an additional bioassay to be used in conjunction with the PK/PD model to inform dose escalation decisions in addition to safety monitoring.
The clinical hold does not relate to the toxicology or manufacturing of MGTA-117.
Magenta has initiated bioassay development.
The Phase 1/2 clinical trial of MGTA-117 is intended to evaluate its safety, pharmacokinetics (PK), and pharmacodynamics (PD) as a single agent in the relapsed/refractory AML and MDS patient population.
Magenta ended Q2 2021 with more than $200 million in cash sufficient to execute its existing plans.
Magenta's MGTA-117 program is the Company's lead targeted conditioning product candidate, an antibody-drug conjugate (ADC) designed to deplete hematopoietic stem cells (HSCs) selectively.
Price Action: MGTA shares are down 14.60% at $7.60 during the market session on the last check Wednesday.
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