Taiho Pharmaceutical Secures Exclusive License for Quemliclustat in Japan and Asia

Arcus Biosciences, Inc. and Taiho Pharmaceutical Co., Ltd. have announced that Taiho has exercised its option for quemliclustat, a small molecule CD73 inhibitor, in Japan and other parts of Asia (excluding mainland China). This move is part of an option and license agreement from September 2017. Taiho’s decision marks the fourth time it has opted into an Arcus program.

In return for exclusive licensing rights to quemliclustat, Taiho will provide an option exercise payment along with additional payments upon reaching certain clinical, regulatory, and commercialization milestones. Should products from this program gain approval, Taiho will also pay royalties on net sales.

Quemliclustat is currently under investigation and has shown potential in blocking the production of adenosine, which is known to suppress immune responses in the tumor microenvironment. High CD73 expression is linked with poorer prognosis in various cancers. By inhibiting CD73, quemliclustat may help activate antitumor immune cells, leading to the death of cancer cells.

Arcus is planning a Phase 3 global study, PRISM-1, in 2024. This study will compare the combination of quemliclustat and chemotherapy against chemotherapy alone for treating patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). This decision follows promising overall survival results from the Phase 1b ARC-8 study presented earlier this year at the American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium.

As part of the collaboration, Taiho will support the development and potential commercialization of quemliclustat and will manage the PRISM-1 study in Japan. This aligns with Taiho’s mission to provide innovative drugs to patients and medical professionals.

In addition to the planned Phase 3 study by Arcus, quemliclustat is also being co-developed with Gilead Sciences. It is being tested in combination with other molecules and chemotherapy in Phase 2 studies for lung and upper gastrointestinal cancers. Currently, quemliclustat remains an investigational drug and is not approved for global use.

The agreement between Taiho and Arcus dates back to 2017 and grants Taiho exclusive rights to develop and commercialize four programs in Japan and certain Asian territories (excluding mainland China). These include quemliclustat (CD73 inhibitor), etrumadenant (a dual A2a/b adenosine receptor antagonist program announced in 2018), zimberelimab (an anti-PD-1 program in 2019), and domvanalimab and AB308 (both part of the anti-TIGIT program announced in 2021).

Outside these territories, Gilead holds the rights to commercialize these programs in the U.S. and co-promote with Arcus, and Gilead also possesses exclusive rights to develop and commercialize them internationally.

Arcus Biosciences is a clinical-stage biopharmaceutical company focused on developing unique molecules and combination therapies for cancer treatment. Collaborating with various industry partners, Arcus aims to expedite the development of first- and best-in-class medicines against well-defined biological targets and pathways. Established in 2015, the company has rapidly advanced multiple investigational medicines into clinical trials, including new combination strategies targeting TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor), HIF-2a, CD39, and AXL.

Meanwhile, Taiho Pharmaceutical is a research-driven company specializing in oncology and immune-related diseases. With a pledge to enhance human health and societal well-being, Taiho is a prominent player in Japan’s oncology sector and is expanding globally through extensive R&D efforts. The company also produces quality products for various medical conditions, improving people's quality of life, and offers consumer healthcare products to support fulfilling lives.