XTX601 / Xilio Therap - LARVOL DELTA

Discovery and optimization of XTX601, a masked claudin 18.2-targeting T cell engager (AACR 2026) - "Collectively, these preclinical data demonstrate the effectiveness of our ATACR masked T cell engager format in reducing systemic activation of T cells while retaining potent anti-tumor activity. XTX601 is the first masked CLDN18.2-targeting TCE and has the potential to address a significant unmet need for patients with CLDN18.2 expressing malignancies including gastric, esophageal, and pancreatic cancers."

Gastrointestinal Cancer • Hematological Malignancies • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Xilio Therapeutics Announces New Preclinical Data at AACR Annual Meeting for XTX601, a Masked T Cell Engager Targeting CLDN18.2 (GlobeNewswire) - "XTX601 demonstrated protease-dependent activation and tumor cell killing in high- and low-expression settings for CLDN18.2, with effective masking of the anti-CD3 domain. XTX601 exhibited robust, dose-dependent anti-tumor activity in multiple murine cell line-derived xenograft models, including GSU gastric carcinoma and OE19 esophageal adenocarcinoma models engrafted with human T cells....Xilio plans to advance its masked T cell engager program targeting CLDN18.2 into investigational new drug (IND)-enabling studies and submit an IND application for this program in 2027."

IND • Preclinical • Esophageal Adenocarcinoma • Gastric Cancer

Xilio Therapeutics to Present New Preclinical Data for its Masked T Cell Engager Program Targeting CLDN18.2 at the American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire)

Preclinical • Solid Tumor

Xilio Therapeutics Highlights…Recent Corporate Updates (Xilio Press Release) - "Xilio today announced:...The nomination of a development candidate for its masked T cell engager program targeting the tumor-associated antigen for CLDN18.2, which has broad potential as a target for gastric, pancreatic, esophageal and lung cancers."

Pipeline update • Esophageal Cancer • Gastric Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

Anticipated Milestones (Xilio Press Release) - "Xilio’s anticipated upcoming milestones include...: (i) Nominate a development candidate for the STEAP1 program (masked T cell engager with co-stimulation) in the first half of 2026; (ii) Advance at least two masked T cell engager programs into IND-enabling studies and submit IND applications for those programs in 2027; (iii) Deliver the Phase 1/2 option data package to Gilead for the efarindodekin alfa program in the first half of 2027."

IND • P1/2 data • Pipeline update • Solid Tumor

Preclinical Data Presented at SITC (GlobeNewswire) - "...Xilio’s masked T cell engager molecules demonstrated potent anti-tumor activity with evidence of reduced systemic toxicity in murine models, supporting the broad applicability and potential best-in-class profile of Xilio’s masked T cell engager formats across a diverse range of targets. The incorporation of co-stimulatory signaling in Xilio’s proprietary SEECR format enhanced durability of anti-tumor activity compared with T cell engager molecules that lacked co-stimulation."

Preclinical • Solid Tumor

Anticipated Milestones for Masked T Cell Engager Programs (GlobeNewswire) - "Xilio nominated a development candidate for its PSMA program (ATACR format) in the third quarter of 2025 and anticipates nominating development candidates for its CLDN18.2 program (ATACR format) in the fourth quarter of 2025 and for its STEAP1 program (SEECR format) in the first half of 2026. Xilio anticipates advancing at least two of these programs into investigational new drug (IND) enabling studies and submitting IND applications for those programs in 2027."

IND • Pipeline update • Solid Tumor

Masked T Cell Engager Programs (GlobeNewswire) - "Xilio anticipates nominating development candidates for its PSMA program (ATACR format), CLDN18.2 program (ATACR format) and STEAP1 program (SEECR format) in the third quarter of 2025, fourth quarter of 2025 and first half of 2026, respectively; Xilio anticipates advancing at least two of these programs into initial IND-enabling studies and submitting IND applications for those programs in 2027."

IND • Pipeline update • Solid Tumor

Xilio Therapeutics Announces Pipeline and Business Updates and First Quarter 2025 Financial Results (GlobeNewswire) - "Xilio anticipates nominating a development candidate for its CLDN18.2 program in the ATACR format in the fourth quarter of 2025 and submitting an IND application in the second quarter of 2027. CLDN18.2 has broad potential as a T cell engager target for gastric, pancreatic, esophageal and lung cancers."

IND • Esophageal Cancer • Gastric Cancer • Lung Cancer • Pancreatic Cancer

Xilio Therapeutics Announces Multiple Masked T Cell Engager Programs (GlobeNewswire) - "Xilio is currently advancing three wholly-owned preclinical programs for masked T cell engager molecules targeting the following tumor-associated antigens: PSMA, CLDN18.2 and STEAP1: Xilio anticipates nominating a development candidate for its PSMA program in the ATACR format in the third quarter of 2025 and submitting an investigational new drug application (IND) in the first quarter of 2027...CLDN18.2 program in the ATACR format in the fourth quarter of 2025 and submitting an IND in the second quarter of 2027...STEAP1 program in the SEECR format in the first half of 2026 and submitting an IND in the second half of 2027."

IND • Preclinical • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Pancreatic Cancer • Prostate Cancer