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iTeos Announces 2025 Strategic Priorities and Anticipated Milestones

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iTeos Therapeutics (ITOS) has outlined its strategic priorities for 2025, highlighting multiple clinical data readouts for its TIGIT program. The company anticipates data from over 400 patients across three trials testing belrestotug + dostarlimab in lung and head & neck cancers. Key developments include Phase 2 data readouts in 2Q25 for NSCLC and throughout 2025 for HNSCC.

The company is advancing EOS-984, with Phase 1 data expected in 2H25, and plans to submit an IND for EOS-215, a potential best-in-class anti-TREM2 antibody, in 1Q25. iTeos maintains a strong financial position with $683.9 million in cash as of September 30, 2024, providing runway through 2027.

The GALAXIES Lung-301 Phase 3 trial has received FDA and NMPA clearance, while the Lung-201 study will report interim data including safety, ORR, and ctDNA data from over 240 patients in 2Q25.

iTeos Therapeutics (ITOS) ha delineato le sue priorità strategiche per il 2025, evidenziando diversi dati clinici riguardanti il suo programma TIGIT. L'azienda prevede dati provenienti da oltre 400 pazienti coinvolti in tre studi che testano belrestotug + dostarlimab nei tumori polmonari e testa-collo. Le principali novità includono la presentazione dei dati della Fase 2 nel secondo trimestre del 2025 per il NSCLC e nel corso del 2025 per l'HNSCC.

L'azienda sta sviluppando EOS-984, con dati di Fase 1 previsti per la seconda metà del 2025, e pianifica di presentare una domanda IND per EOS-215, un potenziale anticorpo anti-TREM2 di classe leader, nel primo trimestre del 2025. iTeos mantiene una solida posizione finanziaria con 683,9 milioni di dollari in contante al 30 settembre 2024, garantendo fondi fino al 2027.

Lo studio GALAXIES Lung-301 di Fase 3 ha ricevuto l'approvazione della FDA e della NMPA, mentre lo studio Lung-201 riporterà dati preliminari tra cui sicurezza, ORR e dati ctDNA da oltre 240 pazienti nel secondo trimestre del 2025.

iTeos Therapeutics (ITOS) ha delineado sus prioridades estratégicas para 2025, destacando múltiples lecturas de datos clínicos para su programa TIGIT. La compañía anticipa datos de más de 400 pacientes en tres ensayos que evalúan belrestotug + dostarlimab en cánceres de pulmón y de cabeza y cuello. Los desarrollos clave incluyen la presentación de datos de Fase 2 en el segundo trimestre de 2025 para NSCLC y a lo largo de 2025 para HNSCC.

La empresa está avanzando en EOS-984, con datos de Fase 1 esperados en la segunda mitad de 2025, y planea presentar una solicitud IND para EOS-215, un posible anticuerpo anti-TREM2 mejor en su clase, en el primer trimestre de 2025. iTeos mantiene una sólida posición financiera con $683.9 millones en efectivo al 30 de septiembre de 2024, asegurando recursos hasta 2027.

El ensayo GALAXIES Lung-301 de Fase 3 ha recibido autorización de la FDA y la NMPA, mientras que el estudio Lung-201 informará sobre datos interinos incluidos seguridad, ORR y datos de ctDNA de más de 240 pacientes en el segundo trimestre de 2025.

iTeos Therapeutics (ITOS)는 2025년 전략적 우선 사항을 설명하며 TIGIT 프로그램의 여러 임상 데이터 발표를 강조했습니다. 이 회사는 belrestotug + dostarlimab를 폐암 및 두경부암에서 시험하는 세 가지 임상 시험을 통해 400명 이상의 환자로부터 데이터를 예상하고 있습니다. 주요 발전 사항으로는 NSCLC에 대한 2상 데이터 발표가 2025년 2분기에 예정되어 있으며 HNSCC에 대해서는 2025년 내내 발표될 것입니다.

회사는 EOS-984의 개발을 진행 중이며, 2025년 하반기에 1상 데이터가 기대되고 있습니다. 또한 EOS-215, 잠재적인 최우수 Anti-TREM2 항체에 대한 IND를 2025년 1분기에 제출할 계획입니다. iTeos는 2024년 9월 30일 현재 6억8,390만 달러의 현금을 보유하고 있어 2027년까지의 자금을 확보하고 있습니다.

GALAXIES Lung-301 3상 임상 시험은 FDA 및 NMPA의 승인을 받았으며, Lung-201 연구는 2025년 2분기에 240명 이상의 환자로부터 안전성, ORR, ctDNA 데이터를 포함한 중간 데이터를 보고할 것입니다.

iTeos Therapeutics (ITOS) a défini ses priorités stratégiques pour 2025, mettant en avant plusieurs résultats cliniques pour son programme TIGIT. L'entreprise s'attend à obtenir des données provenant de plus de 400 patients dans trois essais testant belrestotug + dostarlimab dans les cancers du poumon et de la tête et du cou. Les développements clés incluent des lecture de données de Phase 2 au 2ème trimestre 2025 pour le NSCLC et tout au long de 2025 pour le HNSCC.

L'entreprise fait avancer EOS-984, avec des données de Phase 1 attendues au second semestre 2025, et prévoit de soumettre une demande IND pour EOS-215, un anticorps anti-TREM2 potentiel de classe supérieure, au premier trimestre 2025. iTeos maintient une solide position financière avec 683,9 millions de dollars en liquidités au 30 septembre 2024, assurant des fonds jusqu'en 2027.

L'essai GALAXIES Lung-301 de Phase 3 a reçu le feu vert de la FDA et de la NMPA, tandis que l'étude Lung-201 rapportera des données intermédiaires incluant la sécurité, l'ORR et des données ctDNA de plus de 240 patients au 2ème trimestre 2025.

iTeos Therapeutics (ITOS) hat seine strategischen Prioritäten für 2025 umrissen und mehrere klinische Datenlesungen für sein TIGIT-Programm hervorgehoben. Das Unternehmen erwartet Daten von über 400 Patienten aus drei Studien, die belrestotug + dostarlimab bei Lungen- und Kopf-Hals-Krebs testen. Zu den wichtigsten Entwicklungen gehören Datenlesungen der Phase 2 im 2. Quartal 2025 für NSCLC und im gesamten Jahr 2025 für HNSCC.

Das Unternehmen entwickelt EOS-984, wobei Daten der Phase 1 in der zweiten Hälfte von 2025 erwartet werden. Zudem plant es, im 1. Quartal 2025 einen IND-Antrag für EOS-215, ein potenzielles Best-in-Class Anti-TREM2-Antikörper, einzureichen. iTeos hat eine starke finanzielle Position mit 683,9 Millionen Dollar an liquiden Mitteln nach dem Stand vom 30. September 2024, was eine Finanzierung bis 2027 gewährleistet.

Die GALAXIES Lung-301 Phase-3-Studie hat die Genehmigung von der FDA und NMPA erhalten, während die Lung-201-Studie im 2. Quartal 2025 Zwischenberichte über Sicherheit, ORR und ctDNA-Daten von über 240 Patienten bereitstellen wird.

Positive
  • Strong cash position of $683.9M providing extended runway through 2027
  • FDA and NMPA clearance received for Phase 3 GALAXIES Lung-301 trial
  • Multiple clinical data readouts expected throughout 2025 across three trials
  • $35M milestone payment received for first patient dosing in GALAXIES Lung-301
Negative
  • None.

Insights

iTeos presents a compelling financial position with $683.9 million in cash, providing an extensive runway through 2027. This robust cash position, bolstered by a recent $35 million milestone payment, significantly de-risks the company's clinical development programs. The extended cash runway is particularly valuable given the current biotech funding environment and enables the company to pursue multiple Phase 3 trials without immediate capital needs.

The company's strategic focus on first- and best-in-class therapeutics in the competitive immuno-oncology space positions it well for potential partnership or acquisition opportunities. The advancing TIGIT program, particularly in collaboration with GSK, represents a significant value driver, while the diversified pipeline with EOS-984 and EOS-215 provides multiple shots on goal.

The clinical development strategy demonstrates sophisticated pipeline positioning. The TIGIT program's data readouts from over 400 patients across multiple trials in 2025 will be important for validating the differentiation of belrestotug + dostarlimab combination. The focus on first-line NSCLC and HNSCC - two substantial market opportunities - with PD-L1 patient stratification shows smart trial design.

EOS-984's novel approach targeting ENT1 in T cell metabolism represents an innovative mechanism in the adenosine pathway, distinct from traditional A2AR antagonists. EOS-215's anti-TREM2 approach for targeting tumor-associated macrophages aligns with emerging understanding of myeloid biology in the tumor microenvironment. These early-stage assets provide strategic optionality beyond the lead TIGIT program.

- Multiple TIGIT clinical data readouts anticipated throughout 2025, including >400 patients from two Phase 2 trials and one Phase 1/2 assessing belrestotug + dostarlimab in 1L NSCLC and 1L HNSCC

- EOS-984 Phase 1 monotherapy and PD-1 combination data anticipated in 2H25

- EOS-215, a potential best-in-class anti-TREM2 monoclonal antibody, IND submission anticipated in 1Q25

- Cash balance and investment balance of $683.9 million as of September 30, 2024 expected to provide runway through 2027

WATERTOWN, Mass. and GOSSELIES, Belgium, Jan. 10, 2025 (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 2025.

“As iTeos enters 2025, we are well-positioned to emerge as a leading oncology company by advancing therapies with first- or best-in-class potential that target resistance mechanisms within the tumor microenvironment. Starting in the second quarter, this year will feature robust TIGIT datasets in both non-small cell lung cancer and head and neck cancer, aiming to highlight the differentiation with our unique TIGIT:PD-1 doublet, belrestotug + dostarlimab. We are also excited about EOS-984 and EOS-215, our early-stage programs which demonstrate our track record of designing and developing innovative and differentiated therapies,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “We look forward to a pivotal year for our company, with multiple data readouts and continued progress across our oncology portfolio.”

Program Highlights

Belrestotug (EOS-448/GSKFF28849A): IgG1 anti-TIGIT monoclonal antibody in development for the first-line treatment of locally advanced or metastatic PD-L1-high non-small cell lung cancer (NSCLC) and for the first-line treatment of PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK.

  • GALAXIES Lung-301
    • Enrollment ongoing globally in randomized, double-blind Phase 3 registrational study assessing belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC
    • Food and Drug Administration (FDA) and The National Medical Products Administration (NMPA) granted clearance to advance belrestotug 400mg + dostarlimab as the recommended Phase 3 dose, allowing for the activation of clinical sites in the U.S. and China, respectively.

  • GALAXIES Lung-201
    • Topline interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, in first-line advanced / metastatic PD-L1 high NSCLC anticipated in 2Q25 to include safety, ORR, and ctDNA data from >240 patients, with pembrolizumab monotherapy ORR for 30 patients and PFS data from initial 124 patients treated. Data are expected to be submitted for presentation at a scientific congress in 2H 2025.
  • GALAXIES H&N-202
    • Interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet and triplet with nelistotug in first-line patients with PD-L1 positive recurrent/metastatic HNSCC anticipated in 2025 to include safety and ORR from >150 patients.
  • TIG-006 HNSCC
    • Topline data from the TIG-006 study in cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in 2025 to include safety, ORR, and PFS from a total of 42 patients.

EOS-984: Potential first-in-class small molecule in oncology inhibiting ENT1, a dominant transporter of adenosine involved in T cell metabolism, expansion, effector function, and survival.

  • APT-008
    • Topline data assessing EOS-984 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors anticipated in 2H25.

EOS-215: Potential best-in-class anti-TREM2 with a novel mechanism of action blocking monoclonal antibody targeting tumor-associated macrophages to reprogram the tumor microenvironment.

  • TRM-010
    • Investigative New Drug (IND) application for EOS-215 anticipated in 1Q25.

Financial Updates

Cash Position: The Company’s cash and cash equivalent position was $683.9 million as of September 30, 2024, inclusive of a $35.0 million milestone received relating to the dosing of the first patient in the GALAXIES Lung-301 clinical trial. The Company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing belrestotug + dostarlimab doublet.

About iTeos Therapeutics, Inc.i
Teos 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 immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes. 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 adaptive and 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 EOS-984
EOS-984 is a potential 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.

About EOS-215
EOS-215 is a potential best-in-class monoclonal antibody which blocks ligand binding to triggering receptor expressed on myeloid cells 2 (TREM2), switching off multiple tumor growth and survival promoting activities of tumor resident macrophages and effectively “reprogramming” the macrophages to allow for T cell activation. The therapeutic candidate has shown activity in both in vitro and in vivo highly immune resistant models and is currently in IND-enabling studies.

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 our product candidates; iTeos being well-positioned to emerge as a leading oncology company by advancing therapies with first- or best-in-class potential that target resistance mechanisms within the tumor microenvironment; our plans and expected milestones, including having topline interim data from GALAXIES Lung-201 in 2Q25 that includes safety, ORR, and ctDNA data from > 240 patients, with pembrolizumab monotherapy ORR for 30 patients and PFS data from initial 124 patients treated, our expectation to submit data from GALAXIES Lung-201 for presentation at a scientific congress in 2H 2025, having interim data from GALAXIES H&N-202 in 2Q25 that include safety and ORR from a total of >150 patients, our expectation to submit the GALAXIES H&N-202 data for presentation at a scientific congress in 2H25, having topline data from the first portion of TIG-006 study in cohorts 2C & 2D in 2HQ25 that include safety, ORR, and PFS from a total of 40 patients, having topline data from EOS-984 in 2H25, our expectation to submit an IND for EOS-215 in 1Q25; and our expectation that 2025 will be a pivotal year, with multiple data readouts and continued progress across our oncology portfolio.

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; 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; interim and early data may change as more patient data become available and are subject to audit and verification procedures; 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 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; 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’ Annual Report on Form 10-Q for the period ended September 30, 2024 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 or if 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 undue 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.

For further information, please contact:

Investor Contact:
Carl Mauch
iTeos Therapeutics, Inc.
carl.mauch@iteostherapeutics.com

Media Contact:
media@iteostherapeutics.com


FAQ

When will iTeos (ITOS) report Phase 2 TIGIT data for NSCLC in 2025?

iTeos will report topline interim data from the GALAXIES Lung-201 Phase 2 study in 2Q25, including safety, ORR, and ctDNA data from over 240 patients.

What is iTeos (ITOS) cash runway as of September 2024?

iTeos has $683.9 million in cash and investments as of September 30, 2024, expected to provide runway through 2027.

When will iTeos (ITOS) submit the IND for EOS-215?

iTeos plans to submit the Investigative New Drug (IND) application for EOS-215 in Q1 2025.

What are the key clinical trials for iTeos (ITOS) belrestotug in 2025?

Key trials include GALAXIES Lung-301 (Phase 3), GALAXIES Lung-201 (Phase 2), GALAXIES H&N-202 (Phase 2), and TIG-006 HNSCC study, all evaluating belrestotug + dostarlimab combinations.

When will iTeos (ITOS) report EOS-984 clinical data?

iTeos expects to report topline data for EOS-984 monotherapy and combination with pembrolizumab in advanced solid tumors in the second half of 2025.

iTeos Therapeutics, Inc.

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