User login
Photo by Chad McNeeley
The US Food and Drug Administration (FDA) has granted fast track designation for ProTmune™, a programmed cellular immunotherapy, to reduce the incidence and severity of acute graft-versus-host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT).
ProTmune is produced by modulating a donor-sourced, mobilized peripheral blood (mPB) graft ex vivo with 2 small molecules (FT1050 and FT4145) to enhance the biological properties and therapeutic function of the graft’s immune cells.
The programmed mPB graft is adoptively transferred and administered to a patient as a one-time intravenous infusion.
ProTmune is being developed by Fate Therapeutics, Inc.
The company is conducting a phase 1/2 trial testing ProTmune for the prevention of acute GVHD and cytomegalovirus infection in adults with hematologic malignancies who are undergoing HSCT.
The trial design consists of an initial 10-subject, phase 1 stage, during which all subjects undergoing allogeneic mPB HSCT will receive ProTmune.
Following an independent data monitoring committee safety review, a 60-subject, randomized, controlled phase 2 stage is expected to begin. In this stage, subjects undergoing allogeneic mPB HSCT will be assigned to receive either ProTmune or a conventional mPB cell graft in a 1:1 ratio.
About fast track designation
The FDA’s fast track program is designed to facilitate and expedite the development and review of new drugs intended to treat serious or life-threatening conditions and address unmet medical need.
Through the fast track program, a product may be eligible for priority review. In addition, the company developing the drug may be allowed to submit sections of the biologic license application or new drug application on a rolling basis as data become available.
Fast track designation also provides the company with opportunities for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of the appropriate data needed to support drug approval. And the designation allows for more frequent written communication from the FDA about things such as the design of proposed clinical trials and the use of biomarkers. 
Photo by Chad McNeeley
The US Food and Drug Administration (FDA) has granted fast track designation for ProTmune™, a programmed cellular immunotherapy, to reduce the incidence and severity of acute graft-versus-host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT).
ProTmune is produced by modulating a donor-sourced, mobilized peripheral blood (mPB) graft ex vivo with 2 small molecules (FT1050 and FT4145) to enhance the biological properties and therapeutic function of the graft’s immune cells.
The programmed mPB graft is adoptively transferred and administered to a patient as a one-time intravenous infusion.
ProTmune is being developed by Fate Therapeutics, Inc.
The company is conducting a phase 1/2 trial testing ProTmune for the prevention of acute GVHD and cytomegalovirus infection in adults with hematologic malignancies who are undergoing HSCT.
The trial design consists of an initial 10-subject, phase 1 stage, during which all subjects undergoing allogeneic mPB HSCT will receive ProTmune.
Following an independent data monitoring committee safety review, a 60-subject, randomized, controlled phase 2 stage is expected to begin. In this stage, subjects undergoing allogeneic mPB HSCT will be assigned to receive either ProTmune or a conventional mPB cell graft in a 1:1 ratio.
About fast track designation
The FDA’s fast track program is designed to facilitate and expedite the development and review of new drugs intended to treat serious or life-threatening conditions and address unmet medical need.
Through the fast track program, a product may be eligible for priority review. In addition, the company developing the drug may be allowed to submit sections of the biologic license application or new drug application on a rolling basis as data become available.
Fast track designation also provides the company with opportunities for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of the appropriate data needed to support drug approval. And the designation allows for more frequent written communication from the FDA about things such as the design of proposed clinical trials and the use of biomarkers.
Photo by Chad McNeeley
The US Food and Drug Administration (FDA) has granted fast track designation for ProTmune™, a programmed cellular immunotherapy, to reduce the incidence and severity of acute graft-versus-host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT).
ProTmune is produced by modulating a donor-sourced, mobilized peripheral blood (mPB) graft ex vivo with 2 small molecules (FT1050 and FT4145) to enhance the biological properties and therapeutic function of the graft’s immune cells.
The programmed mPB graft is adoptively transferred and administered to a patient as a one-time intravenous infusion.
ProTmune is being developed by Fate Therapeutics, Inc.
The company is conducting a phase 1/2 trial testing ProTmune for the prevention of acute GVHD and cytomegalovirus infection in adults with hematologic malignancies who are undergoing HSCT.
The trial design consists of an initial 10-subject, phase 1 stage, during which all subjects undergoing allogeneic mPB HSCT will receive ProTmune.
Following an independent data monitoring committee safety review, a 60-subject, randomized, controlled phase 2 stage is expected to begin. In this stage, subjects undergoing allogeneic mPB HSCT will be assigned to receive either ProTmune or a conventional mPB cell graft in a 1:1 ratio.
About fast track designation
The FDA’s fast track program is designed to facilitate and expedite the development and review of new drugs intended to treat serious or life-threatening conditions and address unmet medical need.
Through the fast track program, a product may be eligible for priority review. In addition, the company developing the drug may be allowed to submit sections of the biologic license application or new drug application on a rolling basis as data become available.
Fast track designation also provides the company with opportunities for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of the appropriate data needed to support drug approval. And the designation allows for more frequent written communication from the FDA about things such as the design of proposed clinical trials and the use of biomarkers.