Other Events ·
Xencor reports 45% confirmed response rate for XmAb819 in ccRCC, plans Phase 3 study
XNCRXencor Inc
Xencor announced updated Phase 1 results for XmAb819, an ENPP3 x CD3 bispecific antibody, in patients with advanced clear cell renal cell carcinoma. The company selected 400 mcg/kg as the proposed recommended Phase 3 dose based on a 45.5% confirmed objective response rate and an 82% six-month progression-free survival estimate. Xencor plans to initiate a global randomized registration-enabling study comparing XmAb819 to tivozanib by year-end 2027 and intends to discuss an accelerated approval pathway with the FDA in early 2027. The company also confirmed it expects cash resources to fund operations into 2029. Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for cancer and autoimmune diseases.