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RCUS • CIK 0001724521
We are a late clinical-stage biopharmaceutical company focused on developing differentiated molecules for patients with cancer and inflammatory and autoimmune diseases. Our most advanced molecules are in Phase 3 registrational studies for various cancer indications and we expect our next wave of clinical-stage molecules to come from our inflammation and autoimmune disease programs. Our vision is to leverage our internal small-molecule discovery capabilities to create, develop and commercialize highly differentiated therapies that can have a meaningful impact on patients. The chart below summarizes our current clinical and late pre-clinical stage portfolio: * Taiho holds exclusive licenses in Japan and certain other Asian countries, excluding China, for casdatifan (the “Taiho Territory”). † Gilead and Arcus co-develop globally and share co-promotion rights in the U.S. for domvanalimab and quemliclustat. Gilead holds commercialization rights outside of the U.S. subject to Taiho’s rights for the Taiho Territory. ‡ Gilead has certain option rights as further described under “Licenses and Collaborations”. 1 Table of Contents Oncology Programs Casdatifan (HIF-2α Inhibitor) Casdatifan is our oral, small-molecule inhibitor of HIF-2α, a target that has been commercially validated by the approval of Merck & Co., Inc's ("Merck") HIF-2α inhibitor belzutifan. HIF-2α is a protein that is involved in sensing oxygen availability in multiple organs. In certain tumors, particularly clear cell renal cell carcinoma ("ccRCC"), HIF-2⍺ activity is highly dysregulated as a result of genetic abnormalities. This creates a situation of pseudohypoxia and the abnormal increase in HIF-2⍺-mediated expression of a wide array of proteins involved in cancer cell proliferation, survival, treatment resistance and angiogenesis. We designed casdatifan to have superior pharmacokinetic and pharmacodynamic properties relative to belzutifan, with the goal of achieving greater efficacy in ccRCC patients. The ability for casdatifan to achieve greater efficacy has now been demonstrated in a clinical study in patients. Specifically, in our Phase 1/1b ARC-20 study, which evaluated casdatifan monotherapy in approximately 120 late-line ccRCC patients, casdatifan achieved improvement on every efficacy measure including rate of primary progressive disease, overall response rate ("ORR") and progression-free survival ("PFS"), relative to data reported for belzutifan in a similar patient population. Our goal for casdatifan is to leverage the potential best-in-class efficacy profile and maximize the opportunity for casdatifan by developing this molecule across multiple settings and with optimal combination partners. ARC-20 is designed to generate safety and proof-of-concept clinical data to support and inform our registrational studies for casdatifan. To date, we have completed enrollment of eight cohorts, including four monotherapy cohorts in late-line ccRCC, a cohort evaluating casdatifan plus cabozantinib in ccRCC patients previously treated with immunotherapy and three cohorts evaluating casdatifan in early line settings of ccRCC. The initial registrational studies for casdatifan will focus on combination approaches that build on top of standard of care therapies, while also exploring opportunities for casdatifan to become a foundational standard of care. Our first Phase 3 clinical trial, PEAK-1, is evaluating casdatifan and cabozantinib in ccRCC patients that have received prior immunotherapy, which we believe has a potential global peak sales opportunity of greater than $2 billion. This study has a primary endpoint of PFS and is currently enrolling. Our second Phase 3 clinical trial is expected to evaluate casdatifan in a Tyrosine Kinase Inhibitor ("TKI")-free regimen for the treatment of first-line ccRCC, which we believe represents a potential global peak sales opportunity of greater than $3 billion. This strategy capitalizes on the strong desire by clinicians and patients to avoid TKIs and their associated toxicities in the first-line setting. This Phase 3 study, which we are targeting initiation of by the end of 2026, will be informed by emerging data from the following ongoing cohorts and studies: • A cohort in ARC-20 evaluating casdatifan plus zimberelimab, our anti-PD-1 antibody, in first-line ccRCC. Casdatifan plus anti-PD-1 is likely to serve as the backbone of our front line TKI-free strategy.…
From recent Form 4 filings