iTeos Announces 2024 Strategic Priorities and Anticipated Milestones

- TIGIT program clinical data readouts anticipated in 2024, including two Phase 2 trials assessing belrestotug + dostarlimab in 1L NSCLC and 1L HNSCC

- Adenosine portfolio clinical data readouts anticipated in second half of 2024, including inupadenant’s Phase 2 A2A-005 and EOS-984’s Phase 1 trial

- EOS-984 preclinical data demonstrating novel mechanism of action in the adenosine pathway anticipated in second quarter of 2024

- Cash balance and investment balance of $644.9 million as of September 30, 2023 expected to provide runway through 2026

WATERTOWN, Mass. and GOSSELIES, Belgium, Jan. 08, 2024 (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 and strategic priorities for 2024.

“Over the past twelve months, the TIGIT competitive landscape has substantially evolved, further positioning iTeos and GSK as a potential leader with our high-quality TIGIT:PD-1 doublet, belrestotug + dostarlimab. We remain very encouraged by our progress ahead of a defining year for the company where we anticipate multiple data readouts across our IO portfolio throughout 2024, including three Phase 2 trials, one Phase 1 trial, and the unveiling of preclinical data and the novel mechanism of action for EOS-984,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “We believe 2024 will be an exciting year where we anticipate furthering our ambition to bring best- and first-in-class science to patients and validate our vision of building a pipeline of highly differentiated IO therapies.”

Program Highlights

Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody targeting first-line non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK

• Preparation underway for Phase 3 registrational studies that will evaluate the belrestotug + dostarlimab doublet
• GALAXIES Lung-201: topline data from Phase 2 platform trial assessing belrestotug + dostarlimab doublet in first-line advanced/metastatic non-small cell lung cancer anticipated in 2024
• GALAXIES H&N-202: enrollment ongoing in Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody (GSK’608) in first-line patients with PD-L1 positive recurrent / metastatic HNSCC
• TIG-006 HNSCC: topline data from Phase 2 expansion trial assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced or metastatic HNSCC anticipated in 2024
• TIG-006 mNSCLC: enrollment ongoing in Phase 2 expansion trial assessing belrestotug, dostarlimab, and chemotherapy triplet in first-line advanced or metastatic NSCLC
• TIG-007: the Company has deprioritized the Phase 1/2 TIG-007 trial assessing belrestotug and in combination with Bristol Myers Squibb’s iberdomide due to the evolving treatment landscape in relapsed/refractory multiple myeloma (r/r MM)
• Continued advancement of Phase 1b trials exploring two novel triplets in advanced solid tumors: belrestotug + dostarlimab and GSK’s investigational anti-CD96 antibody (GSK’608), and belrestotug + dostarlimab and GSK’s investigational anti-PVRIG antibody (GSK’562)

Adenosine Pathway

Inupadenant (EOS-850): insurmountable small molecule antagonist targeting adenosine A_2A receptor in second-line NSCLC

• A2A-005: topline data from the dose escalation portion of the Phase 2 trial with inupadenant and platinum-doublet chemotherapy in post-IO metastatic non-squamous NSCLC anticipated in late 2024
• IO-001: completed enrollment of the Phase 2 IO-001 monotherapy high biomarker trial in advanced solid tumors. The Company plans to integrate IO-001 biomarker knowledge into the development strategy of future inupadenant clinical trials.

EOS-984: first-in-class small molecule targeting equilibrative nucleoside transporter 1 (ENT1), a dominant transporter of adenosine on lymphocytes involved in T cell metabolism, expansion, effector function, and survival

• Preclinical mechanism of action data anticipated in the second quarter of 2024
• Topline data from the Phase 1 dose escalation trial in advanced malignancies anticipated in the second half of 2024

Financial Updates

Cash Position: The Company’s cash and cash equivalent position was $644.9 million as of September 30, 2023. The Company continues to expect its cash balance to provide runway through 2026, which includes the initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.

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 three clinical-stage programs targeting novel, validated immuno-oncology pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium.

About Belrestotug (EOS-448/ GSK4428859A)

Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor which contributes to the suppression of innate immune responses against cancer. As an optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and FcγR, a key regulator of immune responses which induces cytokine release and antibody dependent cellular cytotoxicity (ADCC). The therapeutic candidate is progressing in multiple indications in collaboration with GSK.

About Inupadenant (EOS-850)

Inupadenant is a next-generation small molecule antagonist targeting adenosine A_2A receptor (A_2AR), the primary receptor on immune cells whose activation by adenosine suppresses innate and adaptive immune cell responses leading to inhibition of antitumor responses. Optimized for potency, high selectivity of A_2AR, and activity at high adenosine concentrations in solid tumors, inupadenant is uniquely designed with its insurmountable profile to inhibit the ATP-adenosine pathway and has the potential for enhanced antitumor activity as compared to other A_2AR antagonists in clinical development. The therapeutic candidate is in Phase 2 development.

About EOS-984

EOS-984 is a first-in-class small molecule targeting equilibrative nucleoside transporter 1 (ENT1) designed to inhibit the immunosuppressive activity of adenosine and restore immune cell proliferation. The therapeutic candidate has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells and is in Phase 1 development.

Internet Posting of Information

iTeos Therapeutics 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 Therapeutics.

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 belrestotug, inupadenant, and EOS-984; iTeos and GSK being a potential leader with our high-quality TIGIT:PD-1 doublet, belrestotug + dostarlimab; our anticipation to further our ambition to bring best- and first-in-class science to patients and validate our vision of building a pipeline of highly differentiated IO therapies; our expectation to initiate Phase 3 registrational studies that will evaluate the belrestotug + dostarlimab doublet; our plans and expected milestones, including having topline data from GALAXIES Lung-201 and TIG-006 HNSCC in 2024, having topline data from the dose escalation portion of A2A-005 in late 2024, presenting preclinical mechanism of action data from EOS-984 in the second quarter of 2024, and having topline data from the Phase 1 dose escalation trial in advanced malignancies in the second half of 2024; our plan to integrate IO-001 biomarker knowledge into the development strategy of future inupadenant clinical trials; and our expectation that our cash balance will provide runway through 2026, which includes the initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.

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: 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, negative developments in the field of immuno-oncology, such as adverse events or disappointing results, including in connection with competitor therapies, and 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 those risks identified under the heading “Risk Factors” in iTeos’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 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.