Xilio Therapeutics to Present Initial Phase 2 Data for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI

Core Insights - Xilio Therapeutics announced preliminary Phase 1 data for XTX301, a tumor-activated IL-12, showing an improved tolerability profile compared to historical data for rhIL-12, with no dose-limiting toxicities reported [1][2] - The company plans to present initial data from its ongoing Phase 2 trial for vilastobart (XTX101) in combination with atezolizumab at the ASCO GI Cancers Symposium in January 2025 [1][3] XTX301 (IL-12) Preliminary Data - As of November 25, 2024, 34 patients with advanced solid tumors were treated with XTX301 at doses ranging from 5 µg/kg to 60 µg/kg, administered either once every three weeks or once every six weeks [4] - No maximum tolerated dose has been established, and the company continues to enroll patients in Phase 1A and Phase 1B trials [5] - Preliminary results indicated sustained interferon gamma signaling without evidence of tachyphylaxis, which has historically limited other IL-12 agents [6] - No measurable activated XTX301 was detected in peripheral circulation, and no Grade 4 or Grade 5 treatment-related adverse events were reported [7] Vilastobart (XTX101) Phase 2 Trial - Initial data from the ongoing Phase 2 trial for vilastobart in combination with atezolizumab will be presented at the ASCO GI Symposium [3] - The trial focuses on patients with metastatic microsatellite stable colorectal cancer [1][3] - The combination aims to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment [9] Financial Update - On December 18, 2024, Xilio completed an additional private placement with Gilead, raising approximately $8.2 million, bringing the total investment from Gilead to$25 million [8] - The company anticipates that its existing cash and cash equivalents will be sufficient to fund operations into the third quarter of 2025 [8] Company Overview - Xilio Therapeutics is a clinical-stage biotechnology company focused on developing tumor-activated immuno-oncology therapies aimed at improving cancer treatment outcomes while minimizing systemic side effects [11] - The company utilizes a proprietary platform to advance a pipeline of novel immuno-oncology molecules designed to optimize therapeutic indices by localizing anti-tumor activity within the tumor microenvironment [11]