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To co-develop and co-commercialize next-generation cancer immunotherapies
May 29, 2020
By: Contract Pharma
Contract Pharma Staff
Gilead Sciences and Arcus Biosciences have entered into a 10-year partnership valued at nearly $2 billion to co-develop and co-commercialize current and future therapeutic product candidates in Arcus’s pipeline. The agreement will also provide ongoing funding to support Arcus’s research and development programs. Arcus is building an extensive and diverse portfolio of investigational products that target important mechanisms involved in tumor evasion of the immune system, as well as developing drug candidates that target cell-intrinsic pathways important for cancer growth and metastasis. In addition to small molecule products, Arcus is also advancing antibody products that target immune checkpoint receptors, including PD-1 and TIGIT. Arcus will receive $375 million upon closing, consisting of a $175 million upfront payment and a $200 million equity investment from Gilead. Arcus is eligible to receive up to $1.225 billion in opt-in and milestone payments with respect to its current clinical product candidates. Gilead will gain access to Arcus’s current and future investigational immuno-oncology products through the agreement, as Gilead continues to expand its presence in the field. This includes immediate rights to zimberelimab, as well as the right to opt-in to all other current Arcus clinical candidates, which include AB154, AB928 and AB680, upon payment of an opt-in fee that ranges from $200 million to $275 million per program, after delivery of a qualifying data package. If Gilead opts-in to the AB154 program, Arcus is eligible to receive up to $500 million in potential future U.S. regulatory approval milestones. Gilead will receive the right to opt-in to all other programs that emerge from Arcus’s research portfolio over the next 10 years, upon payment of an opt-in fee of $150 million per program after Arcus’s delivery of a qualifying data package. Arcus currently has a clinical-stage pipeline of four immuno-oncology programs, as well as an active oncology discovery pipeline with six preclinical compounds that target critical biological pathways. A core component of Arcus’s strategy is the development of intra-portfolio combinations that include small-molecule and antibody product candidates. Arcus has 10 ongoing clinical studies of molecules in its portfolio, including a randomized Phase 2 study in first-line non-small cell lung cancer evaluating combinations of three Arcus product candidates: AB154, an investigational anti-TIGIT monoclonal antibody; AB928, an investigational A2aR/A2bR antagonist; and zimberelimab (AB122), an investigational anti-PD-1 monoclonal antibody. “We are very pleased to build on Gilead’s growing presence in immuno-oncology with this important new strategic collaboration with Arcus,” said Daniel O’Day, chairman and chief executive officer, Gilead Sciences. “Gilead is committed to accessing the world’s best innovation in immuno-oncology and our agreement with Arcus further demonstrates that commitment. By gaining access to its broad, diverse pipeline and Arcus’s clear strengths in discovery and development, we believe that our partnership with Arcus will significantly accelerate our progress in developing transformative new therapies for cancer.” Terry Rosen, chief executive officer, Arcus, said, “We believe Gilead is an ideal partner for Arcus with its focus on thoughtful and purposeful science, vision to provide transformational therapies in the oncology setting and deeply experienced scientific leadership. This collaboration will allow us to act as one team to maximize the clinical and commercial potential of Arcus’s therapeutic development candidates, greatly amplifying and expediting the opportunities in our pipeline and discovery programs. At the same time, this partnership structure facilitates Arcus’s path to becoming an independent, fully integrated biopharmaceutical company.”
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