On November 30, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, and Taiho Pharmaceutical Co., Ltd., ("Taiho"), an R&D driven specialty pharma company with a focus on oncology, reported that Taiho exercised its option for anti-TIGIT antibodies domvanalimab (development code: AB154) and AB308 from Arcus Biosciences ("Arcus"), in Japan and certain other territories in Asia (excluding China) (Press release, Taiho, NOV 30, 2021, View Source [SID1234596229]). This option exercise is based on an option and license agreement between Taiho and Arcus contracted in September 2017. Taiho has already obtained exclusive rights to etrumadenant (AB928), an adenosine A2a/A2b receptor antagonist, and zimberelimab (AB122), an anti-PD-1 monoclonal antibody. This is the third option exercise to an Arcus program.
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In exchange for the exclusive license, 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.
Domvanalimab is an Fc-silent anti-TIGIT antibody currently under development by Arcus. Similar to PD-1, TIGIT is an immune checkpoint receptor that is expressed on immune cells such as T cells and NK cells. By binding to its ligand CD155, expressed on tumor cells, TIGIT suppresses anti-tumor immune responses, which are thought to be involved with poor prognosis in various types of cancers. Domvanalimab is believed to activate anti-tumor immune responses by blocking CD155 from binding to TIGIT, making it possible for CD155 to bind to and trigger the activating receptor CD226.
Domvanalimab is being developed primarily as a combination therapy with anti-PDx checkpoint inhibitors. The Phase 2 (ARC-7) and Phase 3 (ARC-10) trials of domvanalimab in combination with zimberelimab are currently being conducted by Arcus in first-line metastatic PD-L1≥50% non-small cell lung cancer. A Phase 3 trial (PACIFIC-8) of domvanalimab in combination with durvalumab (Imfinzi, AstraZeneca) is being initiated in Stage III non-small cell lung cancer. Development in other cancer types is also being planned.
Through this collaboration, Taiho will further support the development and commercialization of domvanalimab and will continue its mission to deliver innovative drugs to patients and medical professionals.
About AB308
AB308 is an Fc-enabled anti-TIGIT antibody currently under development by Arcus. In combination with zimberelimab, AB308 is being investigated in an ongoing Phase 1b trial in people with advanced solid and hematologic malignancies.
About Zimberelimab
Zimberelimab is an anti-PD-1 monoclonal antibody currently under development by Arcus. Preliminary data from clinical trials have suggested that zimberelimab has an efficacy and safety profile similar to that of other approved anti-PD-1 monoclonal antibodies.
In addition to combination studies with domvanalimab, Arcus is conducting Phase 1/2 clinical trials of zimberelimab in combination with other Arcus programs in various types of cancers. In Japan, Taiho is conducting a Phase 1 platform trial for zimberelimab in combination with other Taiho products.