USFDAAug 12, 2026, 07:32 AM
Xilio Therapeutics Receives FDA IND Clearance for XTX501
AI Summary
Xilio Therapeutics announced FDA clearance of its Investigational New Drug (IND) application for XTX501, a bispecific PD-1 / masked IL-2, with a Phase 1 clinical trial expected to begin in the second half of 2026. The company is also advancing masked T cell engager programs, with IND applications anticipated in the second half of 2027. For Q2 2026, Xilio reported collaboration and license revenue of $18.7 million and a net loss of $6.4 million, with a cash position of $136.0 million, providing a cash runway into the first quarter of 2028.
Key Highlights
- Received FDA IND clearance for XTX501, a bispecific PD-1 / masked IL-2.
- Expects to initiate Phase 1 clinical trial for XTX501 in H2 2026.
- Advancing IND-enabling studies for masked T cell engagers targeting CLDN18.2 and PSMA+STEAP1.
- Anticipates IND applications for T cell engagers in H2 2027.
- Cash and cash equivalents were $136.0 million as of June 30, 2026.
- Collaboration and license revenue was $18.7 million for Q2 2026.
- Net loss was $6.4 million for Q2 2026, down from $15.8 million in Q2 2025.
- Cash runway expected into Q1 2028.
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