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Xilio Therapeutics Announces Pipeline and Business Updates and Second Quarter 2025 Financial Results
Globenewswire· 2025-08-14 11:30
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]
Xilio Therapeutics Appoints Akintunde Bello, Ph.D., to its Board of Directors
Globenewswire· 2025-06-10 20:30
Company Overview - Xilio Therapeutics, Inc. is a clinical-stage biotechnology company focused on discovering and developing tumor-activated immuno-oncology therapies aimed at improving outcomes for cancer patients while minimizing systemic side effects [4] Leadership Appointment - Akintunde (Tunde) Bello, Ph.D., has been appointed to the board of directors of Xilio Therapeutics, bringing over 25 years of experience in oncology research and development [1][2] - Dr. Bello has a strong track record in developing novel therapies, including significant contributions to cancer immunotherapies such as anti-CTLA-4 and PD-1 [2][3] Expertise and Background - Dr. Bello previously served as senior vice president at Bristol Myers Squibb, overseeing clinical pharmacology and pharmacometrics across multiple therapeutic areas [3] - His academic credentials include a B.Sc. in biomedical sciences, an M.Sc. in instrumentation and analytical science, and a Ph.D. in pharmaceutical sciences [3] Strategic Goals - The company aims to leverage Dr. Bello's expertise to advance its pipeline, including XTX501, a masked PD-1/IL-2 bi-specific therapy, and other bi-specific and tri-specific T cell engager programs [2][3] - Xilio's innovative approach focuses on optimizing the therapeutic index by localizing anti-tumor activity within the tumor microenvironment [4]
Xilio Therapeutics Announces Updated Phase 2 Data for Vilastobart, a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer
Globenewswire· 2025-05-31 12:00
Core Insights - Xilio Therapeutics announced a preliminary objective response rate (ORR) of 26% in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases, demonstrating deep and durable responses lasting up to 37 weeks [1][4][10] - The combination therapy of vilastobart and atezolizumab showed a differentiated safety profile with a low incidence of immune-related adverse events, particularly colitis [2][7][11] - The ongoing Phase 2 trial is evaluating vilastobart in combination with atezolizumab, with plans to expand the study to include a higher dose level [9][13] Patient Data - As of May 12, 2025, 44 patients with metastatic MSS CRC were treated with vilastobart at 100 mg every six weeks and atezolizumab at 1200 mg every three weeks, with a median age of 55 years [3][5] - 80% of patients had previously received three or more lines of anti-cancer therapy, indicating a heavily pre-treated population [3] Anti-Tumor Activity - The preliminary ORR of 26% included seven partial responses, with six confirmed responses, and substantial decreases in tumor biomarkers such as circulating tumor DNA [4][10] - In patients without liver metastases, responses were deep and durable, with reductions in target lesions of up to 71% from baseline [10] Safety Profile - The combination therapy exhibited a low incidence of immune-mediated adverse events, with only 7% of patients experiencing colitis [7][11] - Common treatment-related adverse events included fatigue (30%), infusion-related reactions (23%), and diarrhea (18%) [11] Future Development Plans - Xilio is enrolling a cohort of patients at a higher dose level of 150 mg Q6W for vilastobart in the ongoing Phase 2 trial, with additional data expected in the first half of 2026 [9][12] - The company is seeking partnership opportunities to accelerate the development of the vilastobart program [12]