iTeos Provides Business Updates and Clinical Development Plans for 2023

- 2023 will produce significant advances for both anti-TIGIT monoclonal antibody EOS-448/GSK4428859A and adenosine A2A receptor antagonist inupadenant

- Eleven clinical trials planned or ongoing against multiple tumor types, across three pipeline programs

- EOS-984, a first-in-class program targeting a new mechanism of action in the adenosine pathway, expected to enter clinical studies mid-2023

- Cash balance of $752MM as of September 30, 2022, expected to provide runway into 2026 through multiple inflection points across our portfolio

WATERTOWN, Mass. and GOSSELIES, Belgium, Jan. 09, 2023 (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 outlined business updates that are anticipated to advance its position in 2023, building a path to registration for its promising immunotherapy portfolio.

“2022 was a successful year of execution with multiple trial initiations across both clinical programs. In 2023, we will continue to progress our broad clinical plan against validated targets and benefit from informative readouts across the field. We expect to advance EOS-448, our anti-TIGIT, antibody, into Phase 3 in combination with GSK’s ant-PD-1, Jemperli (dostarlimab) and also continue to advance studies targeting the adenosine pathway through our inupadenant program. Additionally, EOS-984, a first-in-class therapy designed to inhibit a novel target in the adenosine pathway, is expected to enter the clinic in mid-2023 and we are very encouraged by the preclinical data we have in hand,” said Michel Detheux, Ph.D., president, and chief executive officer of iTeos. “Leveraging our scientific expertise, drug development capabilities, financial resources, and our strong partnership with GSK, we are in an enviable position as we kick off 2023. Throughout the year we will continue to advance these novel combinations to unlock the next wave of immunotherapies, generating additional data and value as we work to bring forward new treatment options to people with cancer.”

Clinical Development Plans

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, iTeos is evaluating EOS-448 as a potential next-generation immuno-oncology agent through multiple combination studies. Highlights include:
• Ongoing randomized Phase 2 trial assessing the doublet of GSK’s anti-PD-1, dostarlimab, with EOS-448 in previously untreated advanced / metastatic non-small cell lung cancer.
• Ongoing Phase 2 expansion study assessing the doublet of GSK’s anti-PD-1 dostarlimab with EOS-448 in 1L advanced or metastatic head and neck squamous cell carcinoma.
• Continued exploration of two novel triplets in selected advanced solid tumors, both in Phase 1b trials: EOS-448 with dostarlimab and GSK’s investigational anti-CD96 antibody and EOS-448 with dostarlimab and GSK’s anti-PVRIG.
• Advancement of the monotherapy dose escalation part of a Phase 1/2 trial evaluating EOS-448 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 A_2A receptor, the only high-affinity adenosine receptor expressed on multiple immune cells found in the tumor microenvironment. Highlights include:

• Phase 2 trial ongoing in post-IO metastatic non-squamous NSCLC to evaluate the combination of inupadenant with platinum-doublet chemotherapy compared to standard platinum-doublet chemotherapy.
• The biomarker-high cohort is ongoing, evaluating inupadenant as a monotherapy in patients with solid tumors selected for high biomarker expression.

EOS-984: First-in-class small molecule program targeting a novel mechanism in the adenosine pathway

• New clinical development program with the potential to fully reverse adenosine immune suppression, in combination with inupadenant, but also other standards of care.
• Anticipate entering clinical studies in mid-2023.

Financial Updates

Cash Position: The company’s cash and cash equivalent position was $752.2 million as of September 30, 2022. The company continues to expect its cash balance to provide runway into 2026 to support differentiated clinical programs for EOS-448 and inupadenant as well as advance preclinical programs targeting immunosuppression pathways.

About iTeos Therapeutics, Inc.
iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer. The Company’s innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed with optimized pharmacologic properties for improved clinical outcomes. The first antibody product candidate, EOS-448, is a high affinity, potent, anti-TIGIT antibody with a functional Fc domain, designed to enhance the anti-tumor response through a multifaceted immune modulatory mechanism, currently progressing in multiple indications in collaboration with GSK. The Company is also advancing inupadenant, a next-generation adenosine A_2A receptor antagonist tailored to overcome cancer immunosuppression, into proof-of-concept trials in several indications following encouraging single-agent activity in Phase 1. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium.

Internet Posting of Information
iTeos routinely posts information that may be important to investors in the 'Investors' section of its website at www.iteostherapeutics.com. The Company encourages investors and potential investors to consult our website regularly for important information about iTeos.

Forward-Looking Statements
This press release contains forward-looking statements. Any statements that are not solely statements of historical fact are forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to the potential benefits of EOS-448 and inupadenant; the potential of EOS-984 to fully reverse adenosine immune suppression in combination with inupadenant and other standards of care; our clinical plans and upcoming milestones for 2023, including producing significant advances and generating value, our plan to continue to progress our broad clinical plan against validated targets and benefit from informative readouts across the field, our expectation to progress EOS-448 into Phase 3 in combination with dostarlimab, continuing to advance studies targeting the adenosine pathway, and our expectation that EOS-984 will enter the clinic in mid-2023; the ability of our novel combinations to unlock the next wave of immunotherapies; and iTeos having cash runway into 2026 to support differentiated clinical programs for EOS-448 and inupadenant and advance preclinical programs targeting immunosuppression pathways.

These forward-looking statements involve risks and uncertainties, many of which are beyond iTeos’ control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: market conditions; the expected benefits and opportunities related to the agreement between iTeos and GSK may not be realized or may take longer to realize due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement, challenges and uncertainties inherent in product research and development and manufacturing limitations; iTeos may encounter unanticipated costs or may expend cash more rapidly or more slowly than currently anticipated due to challenges and uncertainties inherent in product research and development and biologics manufacturing; success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; the data for our product candidates may not be sufficient for obtaining regulatory approval to move into later stage trials or to commercialize products; iTeos may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing its product candidates to market, for various reasons, some of which may be outside of iTeos’ control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, regulatory, court or agency decisions such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates and the impact of the COVID-19 pandemic; and those risks identified under the heading “Risk Factors” in iTeos’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review. Statements regarding the Company’s cash runway do not indicate when the Company may access the capital markets.

Any of the foregoing risks could materially and adversely affect iTeos’ business, results of operations and the trading price of iTeos’ common stock. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. iTeos does not undertake any obligation to publicly update its forward-looking statements other than as required by law.