Gilead News: Arthritis Drug, Precision BioSci Deal and Chief Medical Officer Change

Published: Sep 12, 2018 By

Gilead

Gilead Sciences had a lot of news lately. First off, Gilead and Belgium-based Galapagos NV announced results from their FINCH 2 Phase III clinical trial of filgotinib in adults with moderately-to-severely active rheumatoid arthritis. The drug hit its primary endpoint in a proportion of patients reaching an American College of Rheumatology 20 percent response (ACR20) at Week 12.

“Gilead is committed to the development of new therapies that offer meaningful benefit for people living with rheumatoid arthritis and other serious inflammatory diseases,” said John McHutchison, Gilead’s chief scientific officer, Head of Research and Development, in a statement. “These initial Phase III data support the potential of filgotinib, in combination with select disease-modifying drugs, to help patients with active rheumatoid arthritis who do not adequately respond to current biologic disease-modifying agents. These data are particularly encouraging as we look ahead to Phase III results from the ongoing FINCH 1 and 3 trials, which are exploring filgotinib in other populations of patients with rheumatoid arthritis.”

On September 12, Gilead announced that it and Precision BioSciences had inked a strategic collaboration deal to develop drugs that target the in vivo elimination of hepatitis B virus (HBV) using Precision’s genome editing platform, ARCUS.

Current treatments for HBV suppress replication of the virus, but don’t completely clear it. If the treatment is stopped, the virus starts replicating again. Early studies at Gilead using ARCUS nucleases to target HBV covalently closed circular DNA (cccDNA) have shown significant activity against cccDNA and HBV DNA found in human liver cells.

ARCUS is a next-generation genome editing platform made up of a natural genome editing enzyme called a homing endonuclease. It’s built on the ARC nuclease, a fully synthetic enzyme similar to a homing nuclease, but improved so it can be the starting point for a therapy-grade genome editing platform.

Under the terms of the deal, Precision will be responsible for the development, formulation, and preclinical evaluation of the nucleases. Gilead will handle the clinical development and commercialization of possible therapies. Gilead will completely fund the research and development. Precision is eligible for milestone payments up to a total of $445 million as well as tier royalties that can hit the mid-teens.

“Gilead’s cure-based approach to hepatitis B is comprehensive and exciting,” said Derek Jantz, Precision’s chief scientific officer, in a statement. “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.”

On August 14, Gilead had announced several executive changes, including that Andrew Cheng, the company’s chief medical officer, had decided to leave the company. It was announced today that he has been appointed president and chief executive officer of Akero Therapeutics, headquartered in Cambridge, Massachusetts. Cheng joined Gilead in 1999 to head the company’s programs in HIV/AIDS. In 2009, he took on additional responsibility for Gilead’s Development Operations, and in 2015 was named executive vice president. He was appointed chief medical officer in March 2018. Cheng left Gilead on September 7.

“During his time at Gilead, Andrew played a definitive role in bringing forward new medicines that transformed the lives of millions of people with serious illnesses,” said John F. Milligan, Gilead’s president and chief executive officer, in a statement in August. “Andrew played an especially critical part in advancing our portfolio of HIV products, and we’re extremely grateful for his many contributions and wish him all the best in the future.”

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