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Vor Biopharma Says FDA Grants Fast Track Designation To VOR33 For Acute Myeloid Leukemia

Vor Biopharma (VOR), a clinical-stage cell and genome engineering company, announced that its VOR33 was granted Fast Track designation by the U.S. Food and Drug Administration. VOR33 is Vor's lead engineered hematopoietic stem cell or eHSC therapeutic candidate for the treatment of acute myeloid leukemia or AML.

Fast Track designation is intended to facilitate development and expedite review of products designed to treat serious and life-threatening conditions with unmet medical needs.

VOR33 is the lead product candidate from Vor's novel scientific platform, and 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, such as VCAR33 or Mylotarg(tm) (gemtuzumab ozogamicin).

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.

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

The company is also exploring the use of its genome engineered hematopoietic stem cell platform in combination with multiple therapeutic modalities.

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