Post by miamianne67 on Mar 9, 2017 12:41:37 GMT
FDA OKs Pfizer's IND for CAR T candidate UCART19
Mar. 9, 2017 7:02 AM ET|About: Pfizer Inc. (PFE)|By: Douglas W. House, SA News Editor
Pfizer (NYSE:PFE) is set to begin clinical trials in the U.S. evaluating CAR T-cell candidate UCART19 in acute lymphoblastic leukemia (ALL) and B-cell malignancies after the FDA approved its Investigational New Drug (IND) application.
The company is co-developing UCART19 with Servier, who acquired exclusive global rights to the CAR T from Cellectis (NASDAQ:CLLS) in November 2015. Servier, in turn, granted Pfizer exclusive development and commercialization rights in the U.S.
UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN®. UCART19 is initially being developed in ALL. The current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology. UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, “off-the-shelf” T cell based medicinal product.
Mar. 9, 2017 7:02 AM ET|About: Pfizer Inc. (PFE)|By: Douglas W. House, SA News Editor
Pfizer (NYSE:PFE) is set to begin clinical trials in the U.S. evaluating CAR T-cell candidate UCART19 in acute lymphoblastic leukemia (ALL) and B-cell malignancies after the FDA approved its Investigational New Drug (IND) application.
The company is co-developing UCART19 with Servier, who acquired exclusive global rights to the CAR T from Cellectis (NASDAQ:CLLS) in November 2015. Servier, in turn, granted Pfizer exclusive development and commercialization rights in the U.S.
UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN®. UCART19 is initially being developed in ALL. The current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology. UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, “off-the-shelf” T cell based medicinal product.