The data from our preclinical studies clearly indicate that when combined with our modified stem cells, AML-directed therapies eradicate the cancer cells while the normal healthy blood cells continue to thrive and function as normal.
Based on the strength of the data from our preclinical studies, trem-cel (formerly VOR33) has been granted Orphan Drug designation and Fast Track designation from the FDA and a Phase 1/2a clinical trial called VBP101 is now open and actively enrolling patients undergoing a transplant for AML with a high relapse risk. Vor Bio is working with clinical trial investigators at top transplant centers in the U.S. and Canada with close oversight from the U.S. Food & Drug Administration (FDA) and Health Canada, as well as an independent data safety monitoring committee. Together, these groups provide rigorous supervision to ensure patient and donor safety.
Joining a clinical trial
Clinical trials are highly regulated by the US Food and Drug Administration and other governmental regulatory agencies for the safety of patients and for the validity of the data. Vor Bio cannot help you in any way get into a trial. We can, however, direct you to information about the trial and to the clinical investigators who are managing the trial at the various transplant centers.