Arcus Biosciences, Inc. engages in the development and commercialization of immunotherapies. It competes in the segments of the pharmaceutical, biotechnology and other related markets that develop immunotherapies for the treatment of cancer. The company was founded by Terry J. Rosen and Juan Carlos Jaen in 2015 and is headquartered in Hayward, CA.
相关临床试验
58
12 进行中
药物批准
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批准总数
监管机构
0
监管机构数
成立时间
2015
进行中（未招募）
12
20.7%
已完成
29
50.0%
招募中
17
29.3%
暂无批准数据
- Tasrif Pharmaceutical has been granted its second U.S. patent covering humanized monoclonal antibodies targeting CD155, expanding IP protection around lead candidate TSRF-786C IgG4 (S241P). - The patent strengthens Tasrif's position as multiple anti-TIGIT receptor-blocking programs from Roche, Merck, Arcus, and BeiGene have been discontinued following Phase III failures. - Preclinical data for TSRF-786C show sub-nanomolar CD155 binding affinity, target specificity, low predicted immunogenicity, and cross-reactivity with non-human primate CD155. - In humanized mouse models of pancreatic and lung cancer, TSRF-786C significantly increased CD226-positive T cells and NK cells in the tumor microenvironment, supporting combination strategies with anti-PD-1 therapies.
- DelveInsight's latest analysis reveals over 170 companies are developing more than 200 pipeline therapies for pancreatic cancer, marking significant expansion in the treatment landscape. - Advanced candidates include TQB2868, a PD-1/TGF-β bifunctional fusion protein in Phase III development, and Trabedersen, an antisense oligodeoxynucleotide in Phase II/III trials. - Recent regulatory milestones include FDA approval of OPTUNE Pax for locally advanced pancreatic cancer and Orphan Drug Designation for daraxonrasib from Revolution Medicines. - The pipeline emphasizes precision oncology approaches including dual-target immunotherapies, antibody-drug conjugates, and cell-based treatments targeting the tumor microenvironment.
- Arcus and Gilead discontinued development of domvanalimab combination therapy in gastric and esophageal cancers after the Phase III STAR-221 trial failed to improve overall survival compared to Bristol Myers Squibb's Opdivo plus chemotherapy. - The failure represents another significant setback for the TIGIT class of immunotherapies, following similar failures from Roche, GSK, and Merck, leaving AstraZeneca as the primary remaining player in this therapeutic area. - Arcus is pivoting to focus on casdatifan, a HIF-2α inhibitor for kidney cancer, which analysts view as having multi-billion-dollar revenue potential and is wholly owned by the company. - The company maintains $1 billion in cash and investments to support operations through the second half of 2028, while domvanalimab continues in two other Phase III lung cancer trials despite the gastric cancer setback.
- Taiho Pharmaceutical exercised its option to develop and commercialize casdatifan, an investigational HIF-2α inhibitor, in Japan and certain Asian territories under a 2017 agreement with Arcus Biosciences. - Casdatifan is currently being evaluated in the global Phase 3 PEAK-1 trial for clear cell renal cell carcinoma, with Japan expected to participate starting in the first half of 2026. - This marks the fifth option exercise by Taiho from its collaboration with Arcus, expanding their partnership in oncology drug development across multiple therapeutic programs. - Clear cell renal cell carcinoma represents 75-80% of all kidney cancer cases, with kidney cancer showing rising worldwide incidence of approximately 400,000 new cases annually.
- Arcus Biosciences announced that quemliclustat, an investigational small-molecule CD73 inhibitor, received FDA orphan drug designation for treating pancreatic cancer. - The designation provides incentives including tax credits for clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval. - Phase 1 ARC-8 study results showed a median overall survival of 15.7 months with 100mg quemliclustat-based regimens, exceeding historical chemotherapy benchmarks. - The company has initiated PRISM-1, a Phase 3 registrational study evaluating quemliclustat plus chemotherapy versus chemotherapy alone in approximately 610 treatment-naïve metastatic pancreatic cancer patients.
- Arcus Biosciences reported a 46% confirmed overall response rate for the casdatifan plus cabozantinib combination in patients with clear cell renal cell carcinoma who had progressed on prior immunotherapy. - The Phase 1/1b ARC-20 study demonstrated a manageable safety profile with no meaningful overlapping toxicity between the HIF-2α inhibitor casdatifan and tyrosine kinase inhibitor cabozantinib. - These promising results support the initiation of PEAK-1, a Phase 3 study comparing the combination to cabozantinib monotherapy in immunotherapy-experienced patients. - The data were presented at the 2025 ASCO Annual Meeting and exceeded historic benchmarks for either agent alone in the second-line setting.
- DelveInsight's 2025 report reveals over 80 companies are actively developing more than 80 pipeline therapies for pancreatic ductal adenocarcinoma treatment. - Key pharmaceutical companies including Genentech, Revolution Medicines, and Merck Sharp & Dohme are conducting Phase 3 trials with promising novel therapeutic approaches. - Emerging therapies such as Onvansertib, Nadunolimab, and Zimberelimab represent diverse mechanisms of action targeting treatment resistance and immune suppression in pancreatic cancer. - Recent regulatory approvals include Anocca's VIDAR-1 Phase I/II trial targeting KRAS-positive advanced pancreatic cancer, demonstrating growing focus on precision medicine approaches.
- Arcus Biosciences' casdatifan demonstrates superior efficacy profile compared to Merck's Welireg in Phase I/Ib kidney cancer trial, showcasing potential advancement in HIF-2α inhibition. - Gilead Sciences opts not to exercise its option rights for casdatifan development, marking a significant shift in the long-standing partnership with Arcus. - The promising Phase I/Ib results suggest casdatifan could represent a new therapeutic option for kidney cancer patients, pending further clinical development.
- Arcus Biosciences will showcase safety and efficacy data from the ARC-20 study evaluating casdatifan in previously treated kidney cancer patients at the 2025 ASCO GU Symposium. - The presentation will feature initial results from the 100mg QD tablet cohort, which represents the selected dose for upcoming Phase 3 studies. - Updated data from the 50mg BID and 50mg QD expansion cohorts will provide additional insights into casdatifan's performance in patients who received prior TKI and anti-PD-1 therapy.
- Roche's anti-TIGIT drug, tiragolumab, failed to demonstrate a life-extending benefit in a Phase 3 trial for non-small cell lung cancer, raising concerns about the TIGIT inhibitor class. - AbbVie's emraclidine, a muscarinic agonist for schizophrenia acquired from Cerevel Therapeutics, failed in two mid-phase clinical trials, performing no better than placebo. - Cassava Sciences' simufilam, targeting filamin-A for Alzheimer's, failed in a Phase 3 trial, with patients showing no improvement on functional or cognitive measures.
