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WALTHAM, Mass. - Xilio Therapeutics, Inc. (NASDAQ:XLO) announced Friday that its tumor-activated immunotherapy vilastobart showed a 40% objective response rate in heavily pre-treated patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) who had high plasma tumor mutational burden and no liver metastases. The clinical-stage biotech, currently valued at just $43.1 million, has seen its stock price rise 24.77% over the past six months despite the broader market volatility, according to InvestingPro data.
The data comes from an ongoing Phase 2 clinical trial evaluating vilastobart in combination with atezolizumab in MSS mCRC patients. The findings were presented at the Society for Immunotherapy of Cancer Annual Meeting in National Harbor, Maryland.
According to the company, the study demonstrated a statistically significant correlation between plasma tumor mutational burden (TMB) status and treatment response. Patients with TMB levels of 10 mutations per megabase or higher were classified as having high plasma TMB.
The combination therapy showed a generally well-tolerated safety profile with primarily Grade 1 or 2 treatment-related adverse events. Only 5% of patients discontinued treatment due to treatment-related adverse events, and 7% experienced colitis of any grade.
Xilio estimates that approximately 55% of patients with MSS colorectal cancer have high plasma TMB, representing a potentially significant patient population. This is substantially higher than previous estimates using traditional tissue-based assays, which suggested less than 10% of MSS mCRC patients were TMB-high. This expanded market potential comes as the company has posted impressive revenue growth of 536% in the last twelve months, though InvestingPro Tips indicate Xilio is still quickly burning through cash while developing its pipeline.
"These data highlight the potential to use plasma TMB as a predictive biomarker and identify patients with MSS mCRC who may benefit from treatment with vilastobart in combination with a PD-(L)1," said Diwakar Davar, Associate Professor of Medicine and Clinical Director of the Melanoma Program at UPMC Hillman Cancer Center, in the press release.
Xilio stated it is actively seeking a partner to further develop vilastobart in combination with other therapies for MSS colorectal cancer and other tumor types.
The company will host a conference call with cancer experts on Monday to discuss the data. With analyst price targets suggesting a potential 140% upside from current levels and InvestingPro analysis indicating the stock is currently undervalued, investors watching this clinical-stage biotech may want to explore additional financial metrics and 8 more exclusive ProTips available with an InvestingPro subscription.
In other recent news, Xilio Therapeutics, Inc. announced it will present late-breaking Phase 2 data for its anti-CTLA-4 therapy, vilastobart, at the Society for Immunotherapy of Cancer's 40th Annual Meeting. This presentation will focus on the response rates of vilastobart in combination with atezolizumab for certain cancer patients. Additionally, Xilio Therapeutics has received approval to transfer its stock listing from the Nasdaq Global Select Market to the Nasdaq Capital Market. This transfer will take effect at the opening of business on Monday, with the company's shares continuing to trade under the symbol XLO. Furthermore, Xilio has initiated the Phase 2 trial for its tumor-activated IL-12 therapy, efarindodekin alfa (XTX301), for advanced solid tumors. This development has triggered a $17.5 million payment from Gilead Sciences, Inc. under their existing license agreement. Xilio anticipates receiving this payment by the fourth quarter of 2025. These recent developments highlight significant progress in Xilio's clinical trials and corporate activities.
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