iTeos Therapeutics Announces Pipeline Updates and Financial Results for Q3 2024
Key Insights
iTeos received EMA clearance for belrestotug 400mg + dostarlimab in the GALAXIES Lung-301 trial, enabling EU site activation.
Interim data from the inupadenant Phase 2 A2A-005 trial in 2L NSCLC (search) were presented at ESMO-IO.
Enrollment in the EOS-984 Phase 1 monotherapy dose escalation is complete, with combination dosing initiated.
iTeos Therapeutics, Inc. (Nasdaq: ITOS) has reported its financial results for the third quarter of 2024 and provided an update on its clinical development programs. The company is advancing its pipeline of immuno-oncology therapeutics, with key milestones achieved across multiple programs.
Belrestotug Development
Belrestotug (EOS-448/GSK4428859A), an IgG1 anti-TIGIT (search) monoclonal antibody, is being developed in collaboration with GSK for first-line treatment of locally advanced or metastatic PD-L1-selected non-small cell lung cancer (search) (NSCLC (search)) and head and neck squamous cell carcinoma (search) (HNSCC (search)).
The GALAXIES Lung-301, a Phase 3 registrational study, is ongoing, evaluating belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC (search). The EMA has granted clearance to advance belrestotug 400mg + dostarlimab as the recommended Phase 3 dose, facilitating the activation of clinical sites in the EU. The first patient in the EU has been dosed.
Interim data from the Phase 2 GALAXIES Lung-201 study, assessing belrestotug + dostarlimab in first-line advanced/metastatic PD-L1 high NSCLC (search), is expected in 2025. Additionally, interim data from the randomized Phase 2 GALAXIES H&N-202 study, evaluating belrestotug + dostarlimab and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, versus dostarlimab in first-line patients with PD-L1 positive recurrent/metastatic HNSCC (search), is also anticipated in 2025.
Topline data from the first portion of the TIG-006 study in cohorts 2C & 2D, assessing belrestotug + dostarlimab in first-line PD-L1 positive advanced/metastatic HNSCC (search), are expected in 2025.
Adenosine Pathway Programs
iTeos is also developing therapies targeting the adenosine pathway. Inupadenant (EOS-850), an insurmountable small molecule antagonist targeting the adenosine A2A receptor (search), is in Phase 2 development for second-line NSCLC (search). Preclinical, translational, and clinical data from the dose escalation portion of the Phase 2 A2A-005 trial with inupadenant and platinum-doublet chemotherapy in post-IO metastatic non-squamous NSCLC were presented at the European Society for Medical Oncology Immuno-oncology (ESMO IO) Congress 2024.
EOS-984, a potential first-in-class small molecule inhibiting ENT1 (search), a dominant transporter of adenosine, has completed enrollment of its monotherapy dose escalation phase. Dosing has commenced in the first cohort of the EOS-984 + pembrolizumab combination portion of the Phase 1 APT-008 trial. Preclinical and translational data highlighting the mechanism of action, monotherapy and combination activity with anti-PD-1 therapy, and the adenosine signature biomarker were presented at the ESMO IO Congress 2024. Topline data from the Phase 1 APT-008 trial are anticipated in 2025.
Financial Position
As of September 30, 2024, iTeos reported a cash, cash equivalents, and investments position of $648.9 million. Including a $35.0 million milestone receivable from the first patient dosed in the GALAXIES Lung-301 trial, the pro forma cash balance was $683.9 million. The company anticipates this will provide runway through 2027, supporting the potential initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.
Research and Development (R&D) expenses were $36.7 million for the quarter ended September 30, 2024, compared to $30.6 million for the same period in 2023. General and Administrative (G&A) expenses were $12.1 million for the quarter ended September 30, 2024, compared to $12.6 million for the same period in 2023. The net loss for the quarter was $45.4 million, or $1.05 per share, compared to a net loss of $32.2 million, or $0.90 per share, for the same period in 2023.
Michel Detheux, Ph.D., president and chief executive officer of iTeos, stated that the company is well-positioned to enter its next phase of growth and looks forward to providing updates on its pipeline and presenting initial data in head and neck cancer and longer-term follow-up data from GALAXIES Lung-201 next year.