On May 10, 2023 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, reported financial results for the first quarter ended March 31, 2023 and provided business updates on belrestotug, its anti-TIGIT antibody; inupadenant, its adenosine A2A receptor antagonist; and EOS-984, a first-in-class small molecule program targeting a novel mechanism in the adenosine pathway (Press release, iTeos Therapeutics, MAY 10, 2023, View Source [SID1234631410]).

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"iTeos is entering 2023 from a position of strength. We are thoughtfully and methodologically advancing both our lead programs through clinical development to fully unlock their potential. Notably, we’re focused on progressing our multiple clinical studies with belrestotug and GSK’s Jemperli (dostarlimab), with continuing clinical development with both doublet and novel triplets. This includes the ongoing preparations for our first Phase 3 study in first line non-small cell lung cancer with the doublet of belrestotug and dostarlimab, which we are targeting for study initiation by the end of the year. For our adenosine pathway programs, we also remain on track with our first-in-class small molecule program EOS-984, as it enters the clinic in the near term. These advancements follow recently presented biomarker data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting, which have expanded our understanding of the mechanisms of adenosine-mediated immunosuppression, opening up avenues to new patient selection strategies," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Looking ahead, we will continue to leverage our expertise in tumor biology alongside our ability to evaluate novel combinations with our therapeutic candidates, as we continue to execute on our mission to bring a new generation of treatment options to those living with cancer."

Program Highlights:

Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and enhance the anti-tumor response through multifaceted mechanisms.

In collaboration with GSK, late-stage development of belrestotug as a potential next-generation immuno-oncology agent through multiple combination studies is on track. Highlights include:
Ongoing randomized Phase 2 trial assessing the doublet of dostarlimab with belrestotug in previously untreated advanced / metastatic non-small cell lung cancer (NSCLC).
Ongoing Phase 2 expansion study assessing the doublet of dostarlimab with belrestotug in first line advanced or metastatic head and neck squamous cell carcinoma.
Phase 1b trials ongoing exploring two novel triplets in selected advanced solid tumors: belrestotug with dostarlimab and GSK’s investigational anti-CD96 antibody, and belrestotug with dostarlimab and GSK’s investigational anti-PVRIG antibody.
Continued advancement of the monotherapy dose escalation part of a Phase 1/2 trial evaluating belrestotug as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in multiple myeloma.
Adenosine Pathway
Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on multiple immune cells found in the tumor microenvironment. Highlights include:

Progression of the ongoing two-part Phase 2 trial in post-IO metastatic non-squamous NSCLC to evaluate the combination of inupadenant with platinum-doublet chemotherapy compared to standard platinum-doublet chemotherapy.
Data describing a novel mechanism of action of inupadenant in tumor tissue was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting in April 2023. Translational analysis of tumor material from inupadenant clinical trials demonstrated that the predominant cell type in tumor tissue expressing high levels of the target A2A receptor were in fact antibody secreting cells. Additionally, these cells were shown in vitro to be suppressed by adenosine and that such suppression could be reversed by inupadenant.
EOS-984: First-in-class small molecule program targeting a novel mechanism in the adenosine pathway.

This complementary clinical development program has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells. EOS-984’s effects have been shown preclinically to be enhanced by combining with inupadenant and other standards of care.
The company completed Investigational New Drug / Clinical Trials Application-enabling activities, including toxicity studies, and anticipates initiating clinical studies for EOS-984 mid-year 2023.
First Quarter 2023 Financial Results

Cash and Investment Position: The company’s cash, cash equivalents, and investments position was $706.6 million as of March 31, 2023, as compared to $824.0 million as of March 31, 2022. The company continues to expect its cash balance to provide runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $25.6 million for the quarter ended March 31, 2023, as compared to $21.1 million for the same quarter of 2022. The increase was primarily due to an increase in activities related to belrestotug and inupadenant clinical trials.
General and Administrative (G&A) Expenses: G&A expenses were $11.9 million for the quarter ended March 31, 2023, as compared to $10.6 million for the same quarter of 2022. The increase was primarily due to an increase in headcount and related costs compared to the same quarter last year.
Net Income/Loss: Net loss attributable to common shareholders was $15.6 million, or net loss of $0.44 per basic and diluted share, for the quarter ended March 31, 2023, as compared to a net income of $69.6 million, or a net income of $1.96 per basic share and $1.82 per diluted share, for the same quarter of 2022.