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Gilead Sciences and Precision BioSciences announced today that the companies have entered into a strategic collaboration to develop therapies targeting the in vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform, ARCUS.

An estimated 257 million people are living with HBV infection around the world. Current HBV treatments suppress HBV viral replication but do not completely clear the virus. The presence of covalently closed circular DNA (cccDNA) enables HBV replication if treatment is stopped. Preliminary studies at Gilead using ARCUS nucleases to target HBV cccDNA in vitro have demonstrated significant activity against cccDNA and integrated HBV DNA in human hepatocytes.

“Gilead is committed to developing innovative therapies to achieve functional cure for patients with chronic hepatitis B virus infection,” said John McHutchison, MD, chief scientific officer and head of research and development at Gilead. “We are excited about the potential of genome editing and Precision’s ARCUS technology, which has demonstrated promising in vitro activity. We look forward to exploring this technology as an important component of our HBV cure research efforts.”

Under the terms of the collaboration agreement, Precision will be primarily responsible for the development, formulation, and preclinical evaluation of the investigational nucleases, and Gilead will be responsible for the clinical development and commercialization of potential therapies. Gilead will fully fund the research and development. Precision is eligible to receive milestone payments of up to an aggregate of $445 million and tiered royalties that go up to the mid-teens for commercial products developed through the collaboration.

Precision Chief Scientific Officer Derek Jantz commented, “Gilead's cure-based approach to hepatitis B is comprehensive and exciting. Precision is pleased that initial studies with our ARCUS platform have established an important role for genome editing in their HBV program. This is an excellent application for our technology, which has made notable progress toward therapeutic in vivo editing in relevant models over the last year.”

(Sources: Gilead Sciences; Precision BioSciences)

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