Core Insights - Xilio Therapeutics has reported promising clinical data for its investigational therapies, vilastobart and efarindodekin alfa, demonstrating significant potential in treating advanced solid tumors and microsatellite stable metastatic colorectal cancer [2][3][4] Pipeline and Business Updates - Vilastobart has shown a 40% objective response rate (ORR) in heavily pretreated patients with microsatellite stable metastatic colorectal cancer (mCRC) without liver metastases, particularly in those with high plasma tumor mutational burden (TMB) [4][3] - Efarindodekin alfa is being evaluated as a monotherapy in an ongoing Phase 1/2 clinical trial, with early data indicating a well-tolerated safety profile and promising anti-tumor activity [5][9] - XTX501, a bispecific PD-1/IL-2, is advancing towards an IND submission planned for mid-2026 [6][3] Financial Results - As of September 30, 2025, Xilio reported cash and cash equivalents of $103.8 million, a significant increase from $55.3 million at the end of 2024, primarily due to collaboration agreements and a public offering [11][12] - Collaboration and license revenue for Q3 2025 was $19.1 million, compared to $2.3 million in Q3 2024, reflecting growth from partnerships with AbbVie and Gilead [15] - The net loss for Q3 2025 was $16.3 million, an increase from $14.0 million in Q3 2024, driven by higher research and development expenses [15][24] Research and Development Highlights - Xilio's masked T cell engager programs are designed to enhance anti-tumor activity while minimizing systemic toxicity, with promising preclinical data supporting their best-in-class potential [10][8] - The company is actively seeking partnerships to further develop vilastobart in combination with PD-(L)1 or PD1-VEGF therapies for MSS CRC and other tumor types [4][3] Future Outlook - Xilio anticipates sufficient cash runway to fund operations into the first quarter of 2027, supported by recent financial milestones and ongoing collaborations [12][11] - The company plans to nominate development candidates for its CLDN18.2 and STEAP1 programs in late 2025 and early 2026, respectively, with IND applications expected in 2027 [14]

Core Insights - Xilio Therapeutics, Inc. is set to present multiple clinical and preclinical data at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting from November 6-9, 2025, focusing on tumor-activated immuno-oncology therapies for cancer patients [1][2]. Company Overview - Xilio Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing tumor-activated immuno-oncology therapies aimed at improving patient outcomes while minimizing systemic side effects associated with current treatments [2]. Upcoming Presentations - The company will present clinical data for vilastobart, an anti-CTLA-4 therapy, and efarindodekin alfa (XTX301), an IL-12 therapy, along with preclinical data on masked T cell engager programs [2]. - Specific poster presentations include: - "ctDNA as a Potential Surrogate Biomarker for Response to Combination Vilastobart and Atezolizumab in Heavily Pretreated Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)" on November 7, 2025 [4]. - "XTX301, a Tumor-Activated Interleukin-12 (IL-12), Demonstrated IL-12 Pharmacology in Patients with Advanced Solid Tumors: Pharmacodynamic Data from First-in-Human Phase 1 Study" on November 7, 2025 [4]. - "Masked T Cell Engagers Designed to Drive Potent Synthetic Anti-Tumor Immunity with Favorable Tolerability" on November 8, 2025 [4].

Core Insights - Xilio Therapeutics announced updated Phase 2 data for vilastobart, showing deep and durable responses with a differentiated safety profile for anti-CTLA-4 combination therapy [1][5] - The company is on track to nominate its first development candidates for masked T cell engager programs in the second half of 2025 [1][12] - As of June 30, 2025, Xilio reported $121.6 million in cash and cash equivalents, providing a cash runway through the end of the third quarter of 2026 [1][13] Pipeline and Business Updates - Vilastobart is a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody currently evaluated in combination with atezolizumab for advanced solid tumors and metastatic microsatellite stable colorectal cancer [3][14] - XTX301, a tumor-activated IL-12, is designed to stimulate anti-tumor immunity and is being evaluated as a monotherapy in a Phase 1 clinical trial [4][15] - Xilio's masked T cell engager programs include bispecific and tri-specific molecules designed to enhance T cell activation and are advancing through IND-enabling studies [7][9] Financial Results - Collaboration and license revenue for the quarter ended June 30, 2025, was $8.1 million, up from $2.4 million in the same quarter of 2024 [17] - Research and development expenses increased to $15.3 million in Q2 2025 from $11.2 million in Q2 2024, driven by clinical development activities [17] - The net loss for the quarter ended June 30, 2025, was $15.8 million, compared to a net loss of $13.9 million for the same period in 2024 [17][23]