— Gilead Exercises Options to Arcus’s Anti-TIGIT Program (Domvanalimab and AB308), Etrumadenant (A2a/A2b Adenosine Receptor Antagonist) and Quemliclustat (Small Molecule CD73 Inhibitor) —
— Arcus to Receive Option Payments Totaling $725 million —
Gilead Lores,Inc. (Nasdaq GILD) and Arcus Biosciences,Inc. (NYSE RCUS) moment blazoned that Gilead has exercised its options to three programs in Arcus’s clinical- stage portfolio, including bothanti-TIGIT motes, domvanalimab and AB308, as well as etrumadenant and quemliclustat. The companies also added a exploration collaboration as described below. Moment’s sale is subject to applicable antitrust concurrence under the Hart-Scott Rodino Antitrust Improvements Act and other customary ending conditions. The parties anticipate the sale to close by time- end.
Domvanalimab is an Fc-silentanti-TIGIT antibody in Phase 2 and Phase 3 studies innon-small cell lung cancer (NSCLC) and AB308 is an Fc- enabledanti-TIGIT antibody under Phase 1 evaluation. Etrumadenant is a binary adenosine A2a/ A2b receptor antagonist in Phase 1 and Phase 2 studies in NSCLC, colon cancer and prostate cancer. Quemliclustat is a small patch CD73 asset in a Phase 1 study in metastatic pancreatic ductal adenocarcinoma (PDAC).
Gilead has been encouraged by early clinical data generated for each of the three programs. By concluding in early to all three programs now, Gilead and Arcus are suitable to accelerate the clinical development and advancement of these clinical- stage motes and grease the disquisition of treatment combinations across the portfolios. For illustration, Gilead will be suitable to pursue implicit chemotherapy-free rules with Trodelvy ® (sacituzumab govitecan-hziy) in combination with curatives optioned from the Arcus portfolio. Gilead will also have the inflexibility to add Gilead portfolio campaigners to being Arcus studies.
“ Gilead is pursuing some of the most promising mechanisms of action in oncology moment, with the end of achieving better treatment issues for further cases,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Lores. “ The addition of three medial-to late- stage clinical programs into our oncology channel significantly expands the number of transformational drugs we can potentially deliver to people with cancer, while also enabling our pursuit of new combinations.”
Terms of the Exercised Options and Amendment to the Agreement
Under the terms of the parties’ Option, License and Collaboration Agreement (the “ 2020 Agreement”), for the three options that Gilead is exercising moment, Arcus will admit option payments totaling$ 725 million. The parties willco-develop and partake the global costs related to theseprograms.However, Gilead and Arcus willco-commercialize and inversely share gains in the U, If the optioned motes achieve nonsupervisoryapproval.S. Gilead will hold exclusive rights outside theU.S., subject to any rights of Arcus’s being collaboration mates, and Gilead will pay to Arcus tiered royalties.
With Gilead’s early option exercises for all three programs, Gilead and Arcus amended the 2020 Agreement, including as follows
About the Gilead Collaboration
In May 2020, Gilead and Arcus entered into a 10- time collaboration that handed Gilead immediate rights to zimberelimab and the right to conclude into all other Arcus programs arising during the collaboration term. In November 2021, Gilead and Arcus amended the collaboration in connection with Gilead’s option exercise for three of Arcus’s also-clinical stage programs. For all other programs that are in clinical development or new programs that enter clinical development later, the conclude-in payments are$ 150 million per program. Gilead’s option, on a program-by- program base, expires after a specified period of time following the achievement of a development corner for similar program and Arcus’s delivery to Gilead of the needful qualifying data package. Concurrent with the May 2020 collaboration agreement, Gilead and Arcus entered into a stock purchase agreement under which Gilead made a$ 200 million equity investment in Arcus. That stock purchase agreement was amended and paraphrased in February 2021 in connection with Gilead’s increased equity stake in Arcus from 13 to19.7, with an fresh$ 220 million investment.
Upon ending of Gilead’s exercise of its option to a program, the two companies willco-develop and partake global development costs for the common development program, subject to certain conclude-out rights of Arcus in some cases and expenditure caps on its spending and related posterior adaptations. For each optioned program, handed that Arcus has not exercised its conclude-out rights, if any, Arcus has an option toco-promote in the United States with equal profit share. Gilead has the right to simply manipulate any optioned programs outside of theU.S., subject to the rights of Arcus’s being collaboration mates to any homes, and, for clinical stage programs that Gilead has decided into, Gilead will pay Arcus tiered royalties as a chance of earnings ranging from the medial or high teens to the low twenties.
About Arcus Biosciences
Arcus Biosciences is a clinical- stage, global biopharmaceutical company developing discerned motes and combination drugs for people with cancer. In cooperation with assiduity mates, cases and croakers around the world, Arcus is expediting the development of first-or best-in- class drugs against well characterized biology and pathways and studying novel, biology- driven combinations that have the eventuality to help people with cancer live longer. Innovated in 2015, the company has expedited the development of six investigational drugs into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and binary A2a/ A2b) and most lately, HIF-2alfa. For further information about Arcus Biosciences’s clinical andpre-clinical programs, please visitwww.arcusbio.com or follow us on Twitter.
About Gilead Lores
Gilead Lores,Inc. is a biopharmaceutical company that has pursued and achieved improvements in drug for further than three decades, with the thing of creating a healthier world for all people. The company is committed to advancing innovative drugs to help and treat life- hanging conditions, including HIV, viral hepatitis and cancer. Gilead operates in further than 35 countries worldwide, with headquarters in Foster City, California.
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