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(Alliance News) - PureTech Health PLC on Friday said the US Food & Drug Administration has granted Vor Biopharma fast track designation for its VOR33 drug.
VOR33 was developed by PureTech-founded Vor Biopharma and is an engineered hematopoietic stem cell therapy for acute myeloid leukemia, the most common type of blood cancer in adults. PureTech holds an 8.6% stake in Vor.
"Receiving fast track designation is an important milestone for Vor, which signals the FDA's recognition of the serious and life-threatening medical condition of patients facing acute myeloid leukemia and the potential of VOR33 to address this unmet medical need," said Vor Chief Regulatory & Quality Officer Robert Pietrusko.
The drug aims to improve the standard of transplants for patients who are at high risk of relapse. Boston, Massachusetts-based PureTech commented that VOR33 "has the potential to seamlessly integrate into current transplant settings".
"We will continue to work closely with the FDA to expedite the development of VOR33, which is now actively enrolling in its Phase 1/2a clinical trial for acute myeloid leukemia patients who currently have limited treatment options," added Pietrusko.
Vor plans to report the drug's initial clinical data in the first half of 2022.
Shares in PureTech were up 0.6% at 343.00 pence in London on Friday.
By Josie O'Brien; josieobrien@alliancenews.com
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