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.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial