Xilio Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of XTX501 in Patients with Metastatic NSCLC

René Russo, President and chief executive officer of Xilio Therapeutics

“By combining tumor-selective activation of high potency, alpha-optimized IL-2 and inhibition of PD-1/PD-L1 into a single molecule, XTX501 has the potential to become a foundational backbone immunotherapy regimen in both monotherapy and combination settings.”

René Russo, President and chief executive officer of Xilio Therapeutics

“We believe incorporating masking uniquely positions XTX501 to simultaneously leverage these validated mechanisms to enable precise delivery of high potency IL-2 while minimizing the toxicities observed with non-masked IL-2 therapies.”

René Russo, President and chief executive officer of Xilio Therapeutics

“Dosing the first patient with XTX501 marks an important milestone for this program, and we anticipate reporting initial Phase 1 data in metastatic NSCLC in the fourth quarter of 2027.”

Yariv J. Houvras, Chief medical officer of Xilio Therapeutics

“PD-1 bispecifics pair a proven checkpoint target with a second, complementary mechanism that can improve depth and duration of anti-tumor immune response, representing one of the most promising new approaches in immuno-oncology.”

Yariv J. Houvras, Chief medical officer of Xilio Therapeutics

“IL-2 is a powerful driver of T cell expansion, and recent data for treatment with a PD-1/non-masked IL-2 have provided clinical validation of these complementary mechanisms, including in patients whose tumors have stopped responding to first-generation checkpoint inhibitors.”

Yariv J. Houvras, Chief medical officer of Xilio Therapeutics

“By leveraging our clinically-validated masking technology, we believe XTX501 is uniquely positioned to deliver potent, tumor-selective immune activation while overcoming the toxicity and rapid clearance that have limited non-masked IL-2 therapies.”