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WALTHAM, Mass. - Xilio Therapeutics, Inc. (NASDAQ:XLO) unveiled new data across its immunotherapy portfolio at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, highlighting progress in both preclinical and clinical programs. The clinical-stage biotech, currently valued at $43.1 million, has demonstrated impressive revenue growth of 536% in the last twelve months despite operating at a loss.
The clinical-stage biotechnology company presented preclinical data for its masked T cell engager platform, which demonstrated efficient masking and potent anti-tumor activity with a broad therapeutic index. The company's proprietary ATACR and SEECR formats showed potential to overcome challenges associated with current non-masked T cell engagers by leveraging protease-specific activity in the tumor microenvironment. With a strong current ratio of 2.32, Xilio maintains sufficient liquidity to fund its ongoing research efforts.
Xilio also reported Phase 1 data for efarindodekin alfa, a tumor-activated IL-12, which showed promising anti-tumor activity in heavily pre-treated patients with advanced solid tumors. The treatment demonstrated a generally well-tolerated safety profile at dose levels up to the recommended Phase 2 dose, with treatment-related adverse events primarily Grade 1 or 2. Two partial responses were observed, including one in a patient with HPV-negative head and neck squamous cell carcinoma and another in a patient with uveal melanoma.
Additionally, Phase 2 data for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, indicated that circulating tumor DNA (ctDNA) could potentially serve as an early predictor of response to treatment when combined with atezolizumab in patients with microsatellite stable metastatic colorectal cancer.
Xilio has nominated a development candidate for its PSMA program in the third quarter of 2025 and expects to nominate candidates for its CLDN18.2 and STEAP1 programs by the first half of 2026. The company anticipates submitting investigational new drug applications for at least two of these programs in 2027. According to InvestingPro data, Xilio maintains an impressive gross profit margin of 86.8%, though it is currently burning through cash to fund these development programs.
The company has completed enrollment in the Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion portions of its ongoing clinical trial for efarindodekin alfa and has initiated dosing in the Phase 2 portion.
The information presented is based on a press release statement from Xilio Therapeutics.
In other recent news, Xilio Therapeutics reported a 40% objective response rate in its Phase 2 clinical trial for the tumor-activated immunotherapy vilastobart, targeting microsatellite stable metastatic colorectal cancer patients. The data was presented at the Society for Immunotherapy of Cancer Annual Meeting, highlighting the treatment's potential when combined with atezolizumab. Additionally, Xilio announced its plans to present late-breaking Phase 2 data for vilastobart at the upcoming SITC 40th Annual Meeting, focusing on response rates in patients with high plasma tumor mutational burden.
In corporate developments, Xilio Therapeutics has received approval to transfer its stock listing from the Nasdaq Global Select Market to the Nasdaq Capital Market. This change will take effect at the opening of business on Monday, with no changes to the company's trading symbol. Furthermore, Xilio has initiated the Phase 2 trial for its tumor-activated IL-12 therapy, efarindodekin alfa (XTX301), for advanced solid tumors. This milestone has triggered a $17.5 million payment from Gilead Sciences, expected to be received by the fourth quarter of 2025.
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