Research & Development
PureTech reports US FDA's Fast Track Designation for VOR33 to treat AML
13 September 2021 -

Biotherapeutics company PureTech Health plc (Nasdaq:PRTC) (LSE:PRTC) on Friday announced that it has received US Food and Drug Administration(FDA) Fast Track designation (FTD) for VOR33 to treat acute myeloid leukemia (AML).

The US FDA's FTD was awarded to the company's Founded Entity, Vor Biopharma (Nasdaq:VOR).

VOR33, which is Vor's lead engineered hematopoietic stem cell (eHSC) therapeutic candidate for the treatment of acute myeloid leukemia (AML), consists of CRISPR genome-edited hematopoietic stem and progenitor cells that have been engineered to lack CD33. Once infused, VOR33 is designed to protect patients' healthy cells from anti-CD33 therapies, including VCAR33 or Mylotarg (gemtuzumab ozogamicin).

According to the company, VOR33 is intended to replace standard of care transplants for AML patients who are at high risk of relapse and has the potential to seamlessly integrate into current transplant settings.

Currently, Vor is actively enrolling in its Phase 1/2a VOR33 clinical trial for AML patients who currently have limited treatment options and remains on track to report its initial clinical data in the first half of 2022.

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