Xencor Locks Phase 3 Dose for XmAb819 After 45.5% Response Rate in Kidney Cancer
XNCR has more than doubled off its 52-week low of $10.375.
Summary
Xencor picked 400 mcg/kg IV as the proposed Phase 3 dose for XmAb819 after Phase 1 data showed a 45.5% confirmed objective response rate in 11 ccRCC patients and an 82% six-month PFS estimate. Tolerability held up, with only 5.9% discontinuing for adverse events — important for a T-cell engager in solid tumors. The plan is a randomized trial against tivozanib, with a potential registration-enabling study by end of 2027. This moves the program from dose-finding into late-stage planning, and the company says its cash lasts into 2029, so no near-term financing overhang. The caveat is sample size: 11 patients is thin, and the tivozanib comparison (TiNivo-2 benchmark mPFS 5.4 months, cORR 10.5%) is where the thesis gets tested.
At the time of this announcement, XNCR was trading at $25.55 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.9B. The 52-week trading range was $10.38 to $30.61. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.