Magenta Therapeutics has been asked by the FDA to put a brake on blood cancer treatment trials before they begin.
According to Wednesday’s announcement, the FDA hopes to develop additional trials to signal dose escalation and safety monitoring in the proposed Phase 1/2 clinical trials of biotechnology. Magenta submitted a regulatory submission last month to test MGTA-117 in patients with hematological malignancies with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Magenta said additional testing was the only requirement from the clinical hold letter. Authorities did not initiate any cessation related to toxicology or drug production.
The exact date when the study was expected to begin has not been revealed, but Magenta First quarter revenue Earlier this year, the company said, “We look forward to an internal assessment of early safety and pharmacokinetic data in the fourth quarter of 2021.”
Test development work has already begun, and Magenta has not predicted any technical challenges in the process, said Jason Gardener, president and CEO. statement.. Magenta will work with the FDA to decide to apply a new trial for dose escalation, the company said.
“We plan to request a’Type A’meeting in the coming weeks, and if we succeed in resolving this remaining issue, we will begin an investigation in the fourth quarter of 2021,” Gardner said.
Antibody-drug conjugates are intended to selectively deplete hematopoietic stem cells from patients prior to transplantation or stem cell-based gene therapy, reducing the need for high-dose or high-intensity chemotherapy. He said.
MGTA-117 is initially tested in AML and MDS until the FDA reassesses the proposed clinical trial in the future. Magenta believes that this treatment may be applicable to other areas of blood cancer, sickle cell disease, inborn errors of metabolism, and other areas. The drug target CD117 receptor is expressed on the cell surface of hematopoietic stem cells and leukemia cells.
May 2020, magenta Link Before undergoing lentiviral gene therapy during an Abrobio trial, equip Abrobio to assess the potential use of the drug to condition the patient.And last June, biotechnology Teaming In collaboration with Beam Therapeutics, we are conducting research and clinical collaboration to assess the potential use of drugs to treat patients with sickle cell disease and beta-thalassemia receiving Beam’s basic editorial therapy.
The company had over $ 200 million in cash at the end of the second quarter. This is expected to provide a runway to carry out existing plans. Magenta’s share price fell more than 7% to $ 8.25 per share as of 10:30 EST.
https://www.fiercebiotech.com/biotech/fda-tells-magenta-therapeutics-it-can-t-start-leukemia-phase-1-2-clinical-trial The FDA directs Magenta to put a brake on blood cancer trials before starting to develop new dosing tests