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Investing.com -- Xencor Inc (NASDAQ:XNCR) stock rose 4.9% after the clinical-stage biopharmaceutical company reported encouraging initial results from its Phase 1 trial of XmAb819 in patients with advanced clear cell renal cell carcinoma (ccRCC).
The company revealed that its novel ENPP3 x CD3 T-cell engaging bispecific antibody demonstrated anti-tumor activity in heavily pre-treated patients. Among 20 efficacy-evaluable patients treated at dose levels within the target range, 25% achieved a partial response as their best outcome, while the disease control rate reached 70%.
All five responding patients remain on treatment, according to data presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston. Additionally, 50% of all efficacy-evaluable patients within the target dose range continue receiving treatment.
The study enrolled 69 patients across 10 intravenous and 5 subcutaneous dose cohorts. Participants had received a median of 4 prior lines of therapy, with all having previously undergone anti-PD1 and VEGF-TKI treatments.
"XmAb819 demonstrated compelling anti-tumor activity and a well-tolerated safety profile in very heavily pre-treated patients," said Bassil Dahiyat, president and chief executive officer at Xencor.
The most common treatment-related adverse events were cytokine release syndrome, rash, and gastrointestinal issues, primarily Grade 1 or 2 in severity. Grade 3 treatment-related adverse events included rash (16%), liver enzyme elevations (7%), and cytokine release syndrome (4%).
Xencor is continuing dose escalation while also enrolling patients in its first dose-expansion cohort. The company expects to select a recommended Phase 3 dose during 2026 and aims to initiate a pivotal study in advanced ccRCC in 2027.
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