一次情報の記録
重要申請受理
Xilio、XTX501二重特異性PD-1/マスクIL-2のINDをFDAが承認
FDAがXTX501のINDを承認し、同社はPhase 1/2臨床試験に進むことが可能となった。Xilioは2026年後半にPhase 1部分の投与を開始し、2027年後半に転移性NSCLCにおける初期Phase 1データを報告する予定である。
主要事実
出典の抜粋
EX-99.1 2 xlo-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Xilio Therapeutics Reports Second Quarter 2026 Financial Results and Provides Pipeline and Business Updates Received FDA clearance of IND application for XTX501, a potential best-in-class bispecific PD-1 / masked IL-2 Advancing IND-enabling studies for potential first-in-class multi-specific, masked T cell engager programs targeting CLDN18.2 and PSMA+STEAP1; IND applications anticipated in the second half of 2027 Cash runway into the first quarter of 2028 expected to support key milestones across pipeline of next generation multi-specific I-O therapies WALTHAM, Mass., August 12, 2026 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology