- Belrestotug + dostarlimab exceeded pre-defined efficacy criteria for clinically relevant activity observed in an interim assessment of Phase 2 GALAXIES Lung-201- Clinically meaningful tumor reduction observed at every belrestotug + dostarlimab dose vs monotherapy- GSK to provide update on GALAXIES program at upcoming investor event in June- RA Capital and Boxer Capital led $120 million registered direct offering at $17.50, representing a premium of approximately 44% to last close- Pro forma cash and investment balance of $715 million as of March 31, 2024 expected to provide runway through 2027 across a number of impactful portfolio milestones WATERTOWN, Mass. and GOSSELIES, Belgium, May 10, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (NASDAQ:ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today reported financial results for the first quarter ended March 31, 2024 and provided a business update. "After reviewing headline data for an interim assessment of GALAXIES Lung-201, we are thrilled to announce that belrestotug + dostarlimab exceeded our pre-defined efficacy criteria for clinically relevant activity with clinically meaningful tumor reduction at each dose. The data also indicate an acceptable safety profile in line with the TIGIT:PD-1 class," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "We believe this early interim assessment supports our view that quality of components matters and that our TIGIT:PD-1 doublet has the potential to deliver differentiated clinical data. Our GALAXIES clinical development plans remain on track, and we look forward to GSK's update on the GALAXIES program in June. We are also excited to present data from GALAXIES Lung-201 at a medical congress later in 2024." "Additionally, we completed enrollment with no new safety signals observed and passed the futility analysis for efficacy in both combined positive score (CPS) cohorts in the first portion of the TIG-006 trial in first-line recurrent/metastatic PD-L1 positive head and neck cancer. iTeos and GSK have agreed to not continue beyond stage 1 recruitment in the open-label TIG-006 cohorts 2C & 2D and instead focus on generating randomized, controlled data in the ongoing Phase 2 GALAXIES H&N-202 platform study to further support a path to late-stage development in this indication. We are excited to provide an update on the TIG-006 trial at a medical congress later this year," concluded Dr. Detheux.   Program Highlights Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody targeting first-line non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK  Preparation underway to advance GALAXIES clinical program that will evaluate the belrestotug + dostarlimab doublet GALAXIES Lung-201: Interim assessment exceeded pre-defined efficacy criteria for clinically relevant activity with clinically meaningful tumor reduction and showed an acceptable safety profile in line with the TIGIT:PD-1 class. Interim data from Phase 2 platform trial assessing belrestotug + dostarlimab doublet in first-line advanced / metastatic PD-L1 high NSCLC anticipated in second half of 2024.  GALAXIES H&N-202: Enrollment ongoing in randomized Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK's investigational anti-CD96 antibody, nelistotug, in first-line patients with PD-L1 positive recurrent / metastatic HNSCC.  TIG-006 HNSCC: Completed enrollment and passed futility analysis for efficacy of both CPS arms of the first portion of TIG-006 in 1L HNSCC (Cohorts 2C & 2D). iTeos and GSK have agreed to not continue beyond stage 1 recruitment in these open-label cohorts in order to focus on the randomized, controlled GALAXIES H&N-202 trial. Topline data from the first portion of TIG-006 Cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in second half 2024. TIG-006 mNSCLC: Enrollment completed in Phase ...