Xencor Presents Phase 1 Dose Selection Data for XmAb819, a Potential First-in-Class ENPP3 x CD3 Bispecific T-Cell Engager, in Development for Patients With Advanced Clear Cell Renal Cell Carcinoma and ENPP3+ Tumors
Business Wire•25/10/2026•04:35 ET
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Key Highlights
- ➤400 mcg/kg selected as proposed IV RP3D for XmAb819
- ➤400 mcg/kg cohort shows 45.5% cORR and 82% six-month PFS
- ➤Xencor plans FDA accelerated-approval pathway discussions in 1H2027
- ➤Global randomized XmAb819 trial planned against tivozanib in advanced ccRCC
- ➤Xencor expects at least 20 efficacy-evaluable patients at 400 mcg/kg by 1H2027
Expert Statements
Bassil Dahiyat, President and Chief Executive Officer of Xencor
“We are excited to share the XmAb819 Phase 1 dose expansion results presented at ESMO today, along with key additional data, supporting the potential to bring T-cell engagement to treatment of patients with advanced clear cell renal cell carcinoma. We plan to initiate a potential registration-enabling study next year.”
Bassil Dahiyat, President and Chief Executive Officer of Xencor
“XmAb819 exemplifies our approach to engineering XmAb 2+1 bispecific antibodies for selective targeting of malignant cells in solid tumors, and we anticipate that it will become the third XmAb 2+1 candidate to advance into late-stage development. With cash runway into 2029, we are well positioned to continue to pursue an accelerated pace of clinical development across our portfolios in oncology and autoimmune disease.”
Sumanta Pal, Professor and Vice Chair of Academic Affairs at City of Hope Comprehensive Cancer Center and study investigator
“XmAb819 has demonstrated impressive antitumor activity in a heavily pre-treated and difficult-to-treat patient population with advanced clear cell renal cell carcinoma”
Sumanta Pal, Professor and Vice Chair of Academic Affairs at City of Hope Comprehensive Cancer Center and study investigator
“At present, available treatments for renal cell carcinoma include checkpoint inhibitors and targeted therapies along the VEGF axis. XmAb819 is an agent with a wholly distinct proposed mechanism of action as a potential first-in-class ENPP3-targeted T-cell engager. Given the unique proposed mechanism as well as the efficacy and tolerability results we have seen thus far, it is critical to explore this agent in earlier settings and in other ENPP3-expressing malignancies.”
Xencor Presents Phase 1 Dose Selection Data for XmAb819, a Potential First-in-Class ENPP3 x CD3 Bispecific T-Cell Engager, in Development for Patients With Advanced Clear Cell Renal Cell Carcinoma and ENPP3+ Tumors
-- 400 mcg/kg chosen as proposed IV RP3D based on 45.5% cORR, 55% uORR and 82% 6-month PFS Kaplan-Meier estimate --
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