On July 9, 2024 Taiho Pharmaceutical Co., Ltd. ("Taiho") and Arcus Biosciences, Inc. (NYSE:RCUS) reported that Taiho exercised its option for quemliclustat (International Nonproprietary Name; development code: AB680), an investigational small molecule CD73 inhibitor, in Japan and certain other territories in Asia (excluding mainland China). This option exercise is based on an option and license agreement between Taiho and Arcus contracted in September 2017 (Press release, Taiho, JUL 9, 2024, View Source [SID1234644752]). This is the fourth option exercise by Taiho to an Arcus program.
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In exchange for the exclusive license of quemliclustat, Taiho will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercialization milestones, and, if any products from the program are approved, will pay royalties on net sales of such products.
Quemliclustat is an investigational small molecule CD73 inhibitor. In 2024, Arcus plans to initiate the global, registrational Phase 3 study PRISM-1, comparing quemliclustat plus chemotherapy to chemotherapy alone as a treatment for patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Advancement to a Phase 3 study is based on overall survival results observed in the Phase 1b ARC-8 study that were presented earlier this year at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium. Through this collaboration, Taiho will further support the development and potential commercialization of quemliclustat and will operationalize the PRISM-1 study in Japan as part of its mission to deliver innovative drugs to patients and medical professionals.
About Quemliclustat
Quemliclustat is an investigational small molecule CD73 inhibitor. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types. Quemliclustat has been shown to block the production of adenosine. Once the immunosuppressive effects of adenosine are removed, activation of antitumor immune cells may be restored, resulting in cancer cell death. In addition to the planned registrational Phase 3 study PRISM-1 by Arcus, quemliclustat is being codeveloped by Arcus and Gilead Sciences in combination with other molecules within the companies’ portfolios with chemotherapy, including Phase 2 studies in lung and upper gastrointestinal cancers. Quemliclustat is an investigational medicine and is not approved for use globally.
About Taiho and Arcus Agreement
Based on the option and license agreement that Taiho and Arcus entered into in 2017, Taiho has obtained exclusive development and commercialization rights to a total of four programs in Japan and certain other territories in Asia (excluding mainland China): (1) quemliclustat, CD73 inhibitor program, announced today; (2) etrumadenant, a dual A2a/b adenosine receptor antagonist program in 2018; (3) zimberelimab, the anti-PD-1 program in 2019, and; (4) domvanalimab and AB308, both the anti-TIGIT program in 2021. For other territories in the world, Gilead obtained the rights to commercialize in the U.S. and to copromote with Arcus, and Gilead has exclusive rights to develop and commercialize outside the U.S