Xilio Therapeutics sees advances across clinical pipeline, announces XTX30 data

The company states: “Xilio Therapeutics 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. Xilio today announced recent advances across its three clinical-stage programs: 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. Report initial Phase 2 data for XTX101 in combination with atezolizumab in approximately 20 patients with MSS CRC in the fourth quarter of 2024 and in approximately 20 additional patients (40 patients total) in the first quarter of 2025. Xilio continues to enroll patients at the 4.0 mg/kg dose in its ongoing Phase 2 monotherapy trial for XTX202 in patients with metastatic renal cell carcinoma or unresectable or metastatic melanoma. Based on recently accelerated enrollment, Xilio now plans to report Phase 2 monotherapy data for XTX202 in approximately 20 patients treated at the 4.0 mg/kg dose by the end of the first quarter of 2024. XTX301 (tumor-activated IL-12): Xilio today announced encouraging preliminary safety data from its ongoing Phase 1 trial evaluating XTX301 as a monotherapy in dose escalation in patients with advanced solid tumors. As of a data cutoff date of January 5, 2024, nine patients had been treated with XTX301 in the outpatient setting in Phase 1 dose escalation at three dose levels ranging from 5 ug/kg to 45 ug/kg administered once every three weeks. XTX301 was generally well-tolerated across all dose levels with no dose-limiting toxicities observed in patients as of the data cutoff date. Subject to obtaining sufficient additional capital, Xilio today reaffirmed plans to report Phase 1 safety, pharmacokinetic and pharmacodynamic data for XTX301 in patients with advanced solid tumors in the second half of 2024. Xilio continues to anticipate that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the end of the second quarter of 2024.”