Xilio Therapeutics Unveils Late-Breaking Phase 2 Results for Vilastobart in MSS mCRC Patients with Elevated Plasma Tumor Mutational Burden at the 40th Annual SITC Meeting

Written by Emily J. Thompson, Senior Investment Analyst

Source: Newsfilter

Updated: Nov 07 2025

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Clinical Trial Results: Xilio Therapeutics reported a 40% objective response rate (ORR) in heavily pre-treated patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without liver metastases and high plasma tumor mutational burden (TMB) in their Phase 2 trial of vilastobart combined with atezolizumab.
Plasma TMB as a Biomarker: Approximately 55% of patients with MSS CRC are estimated to have high plasma TMB, indicating a significant population that may benefit from the combination treatment, highlighting the potential of plasma-based TMB as a predictive biomarker for response.
Safety Profile: The combination therapy of vilastobart and atezolizumab demonstrated a well-tolerated safety profile, with most treatment-related adverse events being Grade 1 or 2, and only a small percentage of patients discontinuing treatment due to adverse effects.
Future Plans: Xilio is seeking partnerships to further develop vilastobart in combination with PD-(L)1 or PD1-VEGF therapies for MSS CRC and other tumor types, following the promising results from the clinical trial.

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About XLO

Xilio Therapeutics, Inc. is a clinical-stage biotechnology company. The Company is engaged in discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. It is using its proprietary platform to build a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines, antibodies, bispecific and immune cell engagers. Its pipeline products include Vilastobart (XTX101), XTX301, XTX501, and tumor-activated bispecific molecules and immune cell-engaging molecules. XTX101 is an investigational tumor-activated, Fc-enhanced, high-affinity binding anti-CTLA-4 monoclonal antibody. XTX301, a tumor-activated, engineered interleukin 12, or IL-12, therapy.

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Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

Xilio Therapeutics, Inc. (XLO) Announces Q3 Loss and Falls Short of Revenue Projections

Nov 13 2025NASDAQ.COM

Quarterly Performance: Xilio Therapeutics reported a quarterly loss of $0.03 per share, matching expectations, and significantly improved from a loss of $0.22 per share a year ago, while revenues of $19.07 million fell short of estimates by 28.51%.
Stock Outlook: The company's shares have declined by 19% this year, contrasting with the S&P 500's 16.5% gain, and the stock currently holds a Zacks Rank #3 (Hold), indicating expected performance in line with the market.
Earnings Estimates: The consensus EPS estimate for the upcoming quarter is -$0.12 on revenues of $7.96 million, with a fiscal year estimate of -$0.45 on $45.65 million in revenues, reflecting mixed trends in earnings estimate revisions.
Industry Context: Xilio operates within the Medical - Biomedical and Genetics industry, which ranks in the top 35% of Zacks industries, suggesting that industry performance could significantly influence the stock's future.