On May 12, 2022 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of potentially differentiated immuno-oncology therapeutics for patients, reported financial results for the first quarter ended March 31, 2022 and provided recent corporate highlights (Press release, iTeos Therapeutics, MAY 12, 2022, View Source [SID1234614517]).

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"The iTeos team is off to a strong start of the year as we continue to execute on the robust clinical development plans for both of our differentiated clinical-stage immunotherapy programs, EOS-448, our FcγR-engaging anti-TIGIT antibody, and inupadenant, our adenosine A2A receptor antagonist," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Notably, the new data we shared at AACR (Free AACR Whitepaper) in April indicating a decrease of TIGIT-expressing cells in patient tumor biopsies has heightened our optimism for our program, as it showcases key evidence of target engagement within the tumor in patients who were treated with EOS-448 in a clinical trial. These data support the potential of our TIGIT program and encourage us to pursue an efficient and data-driven strategy that will guide future development activities. We look forward to advancing EOS-448 and inupadenant with a goal of bringing new and more effective treatment regimens for advanced cancers."

Program Highlights

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

The company presented preclinical and clinical analyses supporting the multifaceted mechanism of action of EOS-448, including data on pharmacodynamics within the tumor microenvironment, as part of a late-breaking poster at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data highlights are as follows:
Cell-based assays demonstrated the higher potency of EOS-448 relative to competitor anti-TIGIT monoclonal antibodies and provided the basis for its selection as a therapeutic candidate.
A decrease in TIGIT+ Tregs and potentially exhausted CD8 T cells in peripheral blood of patients with advanced cancers following treatment with EOS-448 provide evidence of target engagement and of the multifaceted mechanisms of action for EOS-448.
Treatment of patients with EOS-448 resulted in a decrease of TIGIT-expressing cells in the tumor, making EOS-448 the first anti-TIGIT antibody to demonstrate target engagement in human tumors.
Preclinical analyses of different anti-TIGIT antibody isotypes in combination with an anti-PD1 antibody in a murine cancer model highlighted the importance of FcyR engagement in the anti-tumor activity of TIGIT antibodies.

In collaboration with GSK, iTeos is planning multiple combination studies to evaluate EOS-448 as a potential next-generation immuno-oncology agent. We are continuously evaluating both internal and emerging data in the field to determine the optimal development pathways:

Enrollment is ongoing in a Phase 1b clinical trial in patients with non-small cell lung cancer (NSCLC) assessing the doublet of GSK’s anti-PD-1 (Jemperli (dostarlimab-gxly)) with EOS-448.
iTeos is evaluating the doublets of pembrolizumab with EOS-448 and inupadenant with EOS-448 in patients with solid tumors in an ongoing Phase 1/2 trial.
Plans to initiate Phase 1b trials with novel triplets are on track, including:
Jemperli with EOS-448 and inupadenant in patients with advanced solid tumors
EOS-448 with Jemperli and GSK’s investigational anti-CD96 antibody in patients with NSCLC
Enrollment is underway in a clinical trial evaluating EOS-448 as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in patients with multiple myeloma.
iTeos is working together with GSK to evaluate how best to proceed with additional clinical development of EOS-448 in light of the recent release regarding the Roche SKYSCRAPER-01 study.
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 different immune cells found in the tumor micro-environment.

iTeos is initiating a randomized Phase 2 trial mid-year in metastatic non-small cell lung cancer (mNSCLC) to evaluate the combination of inupadenant with chemotherapy compared to standard of care. A description of this trial will be presented in a Trial in Progress poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Enrollment is ongoing in a Phase 2a trial evaluating inupadenant in combination with pembrolizumab in PD-1 resistant melanoma.
iTeos has begun enrolling patients for the biomarker cohort of IO-001, the ongoing Phase 1b/2a trial, which evaluates inupadenant as a monotherapy in patients with solid tumors selected for high biomarker expression in four cohorts: NSCLC, endometrial cancer, head and neck squamous cell carcinoma and other solid tumors.

Preclinical programs: As part of the company’s ongoing commitment to advancing differentiated programs from discovery into the clinic, iTeos is focused on research programs for novel targets that address pathways of immunosuppression, including its candidate targeting a new mechanism in the adenosine pathway which is under evaluation in Investigational New Drug-enabling studies.

Upcoming Events

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL from June 3-7, 2022
Abstract Title: Randomized phase 2 study evaluating efficacy and safety of inupadenant in combination with chemotherapy in adults with metastatic non–small cell lung cancer (mNSCLC) who progressed on immunotherapy.
Date and Time: June 6, 2022, 9:00 a.m. EDT
Session Title: Lung Cancer—Non-Small Cell Metastatic
Abstract Number: TPS9158

First Quarter 2022 Financial Results

Cash Position: The company’s cash and cash equivalent position was $824.0 million as of March 31, 2022, as compared to $321.4 million as of March 31, 2021. Cash balance provides the company runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $21.1 million for the quarter ended March 31, 2022, as compared to $11.6 million for the same quarter of 2021. The increase was primarily due to an increase in activities related to EOS-448 and inupadenant clinical trials along with increased spending related to the company’s preclinical programs.
General and Administrative (G&A) Expenses: G&A expenses were $10.6 million for the quarter, as compared to $7.0 million for the same quarter of 2021. The increase was primarily due to increased headcount, professional fees, including professional fees attributed to SEC reporting, SOX compliance and consulting costs related to iTeos’ corporate structure in Belgium.
Net Income/Loss: Net income attributable to common shareholders was $69.6 million, or net income of $1.96 per basic share and $1.82 per diluted share, for the quarter ended March 31, 2022, as compared to a net loss of $13.5 million, or a net loss of $0.39 per basic and diluted share, for the first quarter of 2021.