iTeos Announces 2025 Strategic Priorities and Anticipated Milestones

Program Highlights - Belrestotug (EOS-448/GSKFF28849A) is an IgG1 anti-TIGIT monoclonal antibody in development for first-line treatment of locally advanced or metastatic PD-L1-high non-small cell lung cancer (NSCLC) and PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK [1] - Investigative New Drug (IND) application for EOS-215 is anticipated in 1Q25 [2] Business Updates and Strategic Priorities for 2025 - iTeos Therapeutics outlined its business updates and strategic priorities for 2025, aiming to emerge as a leading oncology company by advancing therapies with first- or best-in-class potential targeting resistance mechanisms within the tumor microenvironment [3][4] - The company expects robust TIGIT datasets in NSCLC and head and neck cancer in 2025, highlighting the differentiation with its unique TIGIT:PD-1 doublet, belrestotug + dostarlimab [4] - Early-stage programs EOS-984 and EOS-215 demonstrate the company's track record of designing and developing innovative and differentiated therapies [4] Clinical Trials and Data Readouts - Enrollment is ongoing globally in a randomized, double-blind Phase 3 registrational study assessing belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC [5] - FDA and NMPA granted clearance to advance belrestotug 400mg + dostarlimab as the recommended Phase 3 dose, allowing for the activation of clinical sites in the U.S. and China [5] - Topline interim data from Phase 2 platform study GALAXIES Lung-201 assessing belrestotug + dostarlimab doublet and a triplet with GSK's investigational anti-CD96 antibody, nelistotug, in first-line advanced/metastatic PD-L1 high NSCLC is anticipated in 2Q25, including safety, ORR, and ctDNA data from >240 patients [5] - Interim data from Phase 2 platform study GALAXIES H&N-202 assessing belrestotug + dostarlimab doublet and triplet with nelistotug in first-line patients with PD-L1 positive recurrent/metastatic HNSCC is anticipated in 2025, including safety and ORR from >150 patients [5] - Topline data assessing EOS-984 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors is anticipated in 2H25 [6] - Topline data from the TIG-006 study in cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced/metastatic HNSCC is anticipated in 2025, including safety, ORR, and PFS from a total of 42 patients [11] Pipeline Updates - EOS-984 is a potential first-in-class small molecule targeting equilibrative nucleoside transporter 1 (ENT1) designed to inhibit the immunosuppressive activity of adenosine and restore immune cell proliferation, currently in Phase 1 development [7] - EOS-215 is a potential best-in-class monoclonal antibody blocking ligand binding to TREM2, reprogramming tumor-associated macrophages to allow for T cell activation, currently in IND-enabling studies [8] Financial Updates - The company's cash and cash equivalent position was $683.9 million as of September 30, 2024, inclusive of a$35.0 million milestone received relating to the dosing of the first patient in the GALAXIES Lung-301 clinical trial [13] - The company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing belrestotug + dostarlimab doublet [13] Company Overview - iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, leveraging its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates [14] - The company's innovative pipeline includes three clinical-stage programs targeting novel, validated immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes [14]