Xilio Therapeutics Highlights Recent Advances Across Clinical Pipeline and Encouraging Preliminary Phase 1 Safety Data for XTX301, a Tumor-Activated IL-12, Further Validating the Promise of Its Tumor-Activated Immuno-Oncology Therapies

Dosing XTX301 at 45 ug/kg once every three weeks (dose level 3) in ongoing Phase 1 trial, nearly 100x the maximum tolerated dose of rhIL-12, with no dose-limiting toxicities observed to date

Initiated patient dosing in Phase 1/2 trial for XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab

Based on recently accelerated enrollment, now plan to report Phase 2 trial data for XTX202, a tumor-activated, beta-gamma biased IL-2, at the 4.0 mg/kg dose by end of first quarter of 2024

WALTHAM, Mass., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today highlighted recent advances across its clinical pipeline and reported encouraging preliminary safety data from the first three dose levels in the ongoing Phase 1 trial evaluating XTX301, a tumor-activated IL-12, in patients with advanced solid tumors.

“For more than 20 years, IL-12 development has been relentlessly pursued due to its unique potential to treat immunologically cold tumors. However, treatment with IL-12 has remained out of reach due to the lethal toxicities associated with systemic administration,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “Today we announced that XTX301, our tumor-activated IL-12, has been administered at doses up to 45 ug/kg, which is nearly 100 times the maximum tolerated dose of rhIL-12, with no dose-limiting toxicities observed to date. This is now the third clinical-stage program from the Xilio platform to highlight the potential of our tumor-activated approach.”

Xilio today announced recent advances across its three clinical-stage programs:

XTX101 (tumor-activated, Fc-enhanced anti-CTLA-4)

• Xilio recently initiated patient dosing in the Phase 1 dose escalation portion of the Phase 1/2 trial evaluating XTX101 in combination with atezolizumab in patients with advanced solid tumors.
  
  
• Subject to obtaining sufficient additional capital, Xilio today reaffirmed plans to:
  
  
  • Select a recommended Phase 2 dose for XTX101 in combination with atezolizumab in the second quarter of 2024.
    
    
  • Subject to the results of the Phase 1 combination dose escalation portion of the trial, initiate the Phase 2 portion of the trial for XTX101 in combination with atezolizumab in patients with microsatellite stable colorectal cancer (MSS CRC) in the third quarter of 2024.