WALTHAM, Mass. - Xilio Therapeutics, Inc. (NASDAQ: XLO), a clinical-stage biotechnology company, announced initial clinical data from its ongoing Phase 1C trial evaluating a new combination of cancer treatments. The trial involves vilastobart, a novel anti-CTLA-4 antibody, and atezolizumab, a PD-L1 inhibitor, in patients with advanced solid tumors. Early results suggest potential anti-tumor activity, particularly in difficult-to-treat, microsatellite stable colorectal cancer (MSS CRC) with liver metastases, a group currently facing limited treatment options.
The data, set to be presented at the Society for Immunotherapy of Cancer's 39th Annual Meeting on November 8, 2024, in Houston, Texas, showed unconfirmed partial responses in two patients with "cold" tumors, which are typically resistant to immunotherapies. One patient with MSS CRC experienced complete resolution of a metastatic liver lesion, a significant finding given the prevalence and resistance of liver metastases in MSS CRC.
The safety profile of the treatment combination was also highlighted, with patients generally tolerating the therapy well and experiencing minimal immune-related adverse events. No Grade 4 or 5 treatment-related adverse events were reported, and the most common treatment-related adverse events of any grade included infusion-related reactions, increases in certain liver enzymes, and fatigue.
Based on these findings, Xilio has identified an initial recommended Phase 2 dose for vilastobart and continues to enroll patients in the Phase 1C dose escalation. The company anticipates reporting initial data from the Phase 2 trial for the combination in metastatic MSS CRC patients, including those with liver metastases, in the fourth quarter of 2024.
While these results are preliminary and further research is needed to confirm the efficacy and safety of the treatment, the combination of vilastobart and atezolizumab could represent a new therapeutic option for patients with MSS CRC, a disease that has seen a rising incidence, particularly among younger adults.
The information in this article is based on a press release statement from Xilio Therapeutics.
In other recent news, Xilio Therapeutics has been put on notice for potential delisting from the Nasdaq Global Select Market due to its share price falling below the required $1.00. The biopharmaceutical company has until March 10, 2025, to regain compliance by ensuring its closing bid price reaches or exceeds $1.00 per share for ten consecutive business days. If compliance is not achieved, Xilio may face delisting procedures, though the company can appeal this decision.
Recent developments also highlight Xilio's second-quarter net loss of $14 million, with cash reserves of $75 million projected to last until 2025. The firm is focusing its clinical efforts on two significant trials, XTX101 and XTX301, with results expected later this year. TD Cowen has reaffirmed its Buy rating on Xilio, signaling confidence in the company's clinical direction.
In addition, Xilio announced the addition of Aoife Brennan, M.D., and James Shannon, M.D., to its board of directors, and secured approximately $11.3 million through a private investment involving Bain Capital Life Sciences and Rock Springs Capital. The company is also partnering with Gilead Sciences (NASDAQ:GILD) to advance the XTX301 program, while discontinuing monotherapy development of XTX202 and seeking collaborations for its advancement as a combination therapy. Lastly, in a cost-saving measure, Xilio is reducing its workforce by approximately 21%, expected to incur one-time costs of around $1 million.
InvestingPro Insights
Xilio Therapeutics' recent clinical data announcement aligns with its position as an emerging biotechnology company focused on developing innovative cancer treatments. According to InvestingPro data, Xilio has a market capitalization of $56.7 million, reflecting its early-stage status in the competitive biotech landscape.
The company's financial metrics provide context to its clinical progress. With revenue of $2.36 million in the last twelve months as of Q2 2023, Xilio is still in the early stages of commercialization. This is typical for biotechnology firms investing heavily in research and development. The company's operating income of -$66.7 million in the same period underscores the substantial costs associated with clinical trials and drug development.
InvestingPro Tips highlight that Xilio "holds more cash than debt on its balance sheet," which is crucial for funding ongoing research and clinical trials. This financial position may provide the company with the runway needed to advance its promising cancer treatments through the development pipeline.
Another relevant InvestingPro Tip notes that Xilio is "quickly burning through cash," which is common for biotech companies in the clinical trial phase. This cash burn rate emphasizes the importance of the company's recent clinical data, as positive results could potentially attract investor interest or partnership opportunities to support further development.
For investors interested in a deeper analysis, InvestingPro offers 7 additional tips for Xilio Therapeutics, providing a more comprehensive view of the company's financial health and market position.
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