Nov. 5 Quick Takes: Setback for bluebird sinks shares; plus Cellectis, CRISPR, REMS, Novocure 

bluebird delays sickle cell BLA
bluebird bio Inc. (NASDAQ:BLUE) lost $9.72 (17%) to $48.83 Thursday after disclosing its BLA submission to FDA for LentiGlobin to treat sickle cell disease will be delayed to late 2022 from 2H21. The biotech cited COVID-19 as well as new CMC requirements from FDA to demonstrate analytical comparability between clinically and commercially produced lentiviral vectors and edited cells. The gene-modified cell therapy is approved in Europe as Zynteglo to treat transfusion-dependent β thalassemia.

Signs of efficacy for Cellectis’ off-the-shelf CAR T
Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) gained 10% to $18.13 on early evidence that its allogeneic CD22-targeted CAR T cell therapy UCART22 may help treat B cell acute lymphoblastic leukemia (ALL) without triggering graft-versus host disease (GvHD). In an abstract released ahead of December’s American Society of Hematology meeting, UCART22 led to an ORR of 40% in the first five patients treated with the off-the-shelf CAR T cell therapy, with two of three patients in the lowest dose arm achieving a CR with incomplete hematologic recovery. Two of the five patients experienced serious treatment-emergent serious adverse events...