Durham’s Precision BioSciences Inks $445M-Plus Hepatitis B Deal With Gilead

Precision BioSciences, a Durham-based genome editing company, has formed a strategic collaboration potentially worth more than $445 million with global biopharmaceutical company Gilead Sciences, to develop new therapies aimed at curing hepatitis B infections.

An estimated 257 million people around the world live with hepatitis B and, while current treatments suppress hepatitis B virus (HBV) replication, they don’t completely clear up the virus. The new therapies under development by Gilead and Precision will use Precision’s proprietary genome editing platform, ARCUS, to target the covalently closed circular DNA (cccDNA)  that enables HBV to reproduce. Preliminary studies by Gilead using ARCUS nucleases in vivo have demonstrated significant activity against cccDNA and integrated HBV DNA in human liver cells.

“Gilead is committed to developing innovative therapies to achieve functional cure for patients with chronic hepatitis B virus infection,” said John McHutchison, M.D., chief scientific officer and head of research and development at Gilead. “We look forward to exploring this technology as an important component of our HBV cure research efforts.”

Under the terms of the collaboration, Precision will be primarily responsible for development, formulation and preclinical evaluation of the investigational nucleases. Gilead will be in charge of clinical development and commercialization of potential therapies and will fully fund research and development. Precision will be eligible to receive milestone payments  totaling up to $445 million, as well as tiered royalties for commercial products developed through the alliance.

“Precision is pleased that initial studies with our ARCUS platform have established an important role for genome editing in Gilead’s HBV program,” said Precision Chief Scientific Officer Derek Jantz, Ph.D. “This is an excellent application of our technology, which has made notable progress toward therapeutic in vivo editing in relevant models over the last year.”

Precision, a spinout company of Duke University, has grown beyond 100 employees and expects to have about 140 on the payroll by 2019, an executive said earlier this year. The company has raised about $160 million in capital. Gilead is among the earlier investors.