Iteos Therapeutics

bluebird bio, a pioneer in gene therapies for severe genetic diseases, has appointed three new executives to strengthen its leadership team as the company focuses on commercial execution.

Elevation Oncology has agreed to be acquired by Concentra Biosciences, controlled by hedge fund Tang Capital Partners, for $0.36 per share in cash with additional contingent value rights.

• iTeos Therapeutics and GlaxoSmithKline have discontinued development of their TIGIT inhibitor belrestotug after Phase II clinical trials failed to meet efficacy endpoints in non-small cell lung cancer and head and neck squamous cell carcinoma. • The setback represents another blow to the TIGIT inhibitor class, which has faced multiple clinical disappointments despite initial promise as a potential breakthrough in immuno-oncology combination therapies. • The companies will now redirect resources toward other pipeline assets, while researchers continue to investigate whether specific biomarkers might identify patient subgroups who could benefit from TIGIT-targeted therapies.

GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients.

• e-therapeutics has presented new preclinical data demonstrating ETX-312, their GalOmic siRNA candidate, significantly improves NAFLD Activity Score in MASH mouse models both as monotherapy and in combination with other agents. • The experimental treatment showed comparable fibrosis progression reduction to GLP-1/GIP receptor agonists and FGF-21 analogues, with statistically significant reductions in hepatic collagen staining and circulating biomarkers. • ETX-312, currently in IND-enabling studies, is being developed with potential for quarterly subcutaneous dosing, with regulatory submission planned by the end of 2025.

• iTeos Therapeutics raises $120 million in direct offering led by RA Capital Management and Boxer Capital, extending cash runway through 2027 for advancing belrestotug development. • Interim results from GALAXIES Lung-201 study show clinically meaningful reduction with belrestotug-Jemperli combination in previously untreated advanced NSCLC patients. • The funding will support multiple phase 3 studies of belrestotug in combination with GSK's PD-1 inhibitor Jemperli, building on promising efficacy data.

• Interim Phase 2 GALAXIES Lung-201 study demonstrates superior objective response rate for belrestotug-dostarlimab combination compared to dostarlimab monotherapy in PD-L1-high non-small cell lung cancer patients. • Pivotal data from the Phase 2 GALAXIES Lung-201 trial is scheduled for release in 2025, with additional Phase 2 results in head and neck squamous cell carcinoma expected the same year. • The promising interim results could positively impact the ongoing Phase 3 GALAXIES Lung-301 study, potentially strengthening the treatment's market position in frontline NSCLC therapy.

GSK and iTeos Therapeutics have discontinued development of their anti-TIGIT antibody EOS-448/GSK4428859 after failing to meet efficacy endpoints in a non-small cell lung cancer trial.

• Incyte has halted the development of zilurgisertib, an ALK2 inhibitor, due to limited efficacy observed in a Phase I trial for myelofibrosis-associated anemia and fibrodysplasia ossificans progressiva. • iTeos Therapeutics has deprioritized inupadenant, an A2AR blocker, for metastatic non-small cell lung cancer after Phase II data showed insufficient clinical activity to justify further investment. • Both companies are shifting focus to other pipeline candidates, with iTeos planning to provide further details on its prioritized therapies in 2025.

• iTeos Therapeutics has deprioritized inupadenant for non-small cell lung cancer (NSCLC) treatment due to underwhelming Phase II trial results. • The Phase II A2A-005 trial assessed inupadenant with chemotherapy in post-immunotherapy metastatic NSCLC patients, meeting safety endpoints but showing limited efficacy. • The objective response rate (ORR) of inupadenant plus chemotherapy was 63.9%, similar to standard chemotherapy alone, questioning its added benefit. • iTeos will now focus on its TIGIT antibody belrestotug (EOS-448) in Phase III trials for NSCLC, developed with GSK, showing promising earlier results.