Editas Medicine's science head Albright leaves for new job just as biotech gets trial clearance for sickle cell therapy
Editas Medicine has received the FDA’s blessing to enter the clinic with its first ex vivo cell therapy — but it will do so without CSO Charles Albright, who is leaving his post for the same gig at an early-stage company.
The FDA clearance was announced minutes after Editas shared word of Albright’s departure early Monday morning. The bittersweet news caused the biotech’s stock $EDIT to sink more than 12%, with shares hovering around $79 apiece.
While we don’t know exactly where Albright is heading next, an Editas spokesperson hinted that it’s something early-stage. The Bristol Myers Squibb vet earned his doctorate in biology from MIT, and worked at the Cambridge, MA-based biotech for over four years.
“We have an exceptional team in place, and we are confident that important milestones for our pipeline and programs will be met while we search for a replacement for Charlie,” the spokesperson said in an email.
Editas is now beginning the search for a new CSO as it aims to dose patients this year in the safety portion of a Phase I/II trial for its sickle cell candidate, EDIT-301.
Sickle cell disease is an inherited blood disorder caused by a mutation in the beta-globin gene that leads to polymerization of the sickle hemoglobin protein (HbS). The disease is characterized by misshapen red blood cells, which can block blood flow and cause anemia, pain, organ failure and, in some cases, death.
EDIT-301 uses sickle patient CD34+ cells that are genetically modified using a CRISPR/Cas12a ribonucleoprotein (RNP). Editas says that red blood cells derived from EDIT-301 CD34+ cells show a sustained increase in fetal hemoglobin (HbF) production, which fights sickle cell disease by inhibiting HbS polymerization.
“The FDA’s clearance for initiation for our EDIT-301 clinical trial is an exciting moment for us and the patients we hope to serve. We look forward to bringing this potentially best-in-class, one-time, durable medicine into the clinic and to patients,” Editas CEO Cindy Collins said in a statement.
The Phase I/II trial, dubbed RUBY, is expected to kick off this year, and Editas plans on submitting another IND application for the candidate to treat beta-thalassemia by the end of the year. But before it can begin the efficacy portion of the RUBY study, the biotech says it has to clear up a partial clinical hold by “developing an improved potency assay.”
Back in August, Editas snagged the rights to its lead candidate, EDIT-101, back from AbbVie. The pharma picked up the gene editing program when it acquired Allergan, which had paid $90 million upfront to form a CRISPR alliance with Editas a few years ago. The program centers on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.
Collins said at the time that she was “pleased” to get the ocular programs back, and that Editas planned to continue a Phase I/II trial for EDIT-101 called BRILLIANCE. The company expects to dose the first patient in an adult mid-dose cohort of the trial in Q1 2021, and read out initial data by the end of the year.
It also expects to declare a new candidate for retinitis pigmentosa type 4 (adRP4) by the end of the year.
“I have greatly enjoyed working alongside the extremely talented team here at Editas Medicine. Together, we advanced the revolutionary CRISPR gene editing system into a pipeline of experimental medicines,” Albright said in a statement. “I look forward to watching Editas Medicine’s successes continue in the future, developing many transformative medicines for people in great need.”