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iTeos Announces First Patient Dosed in GALAXIES Lung-301 Phase 3 Study, Earning $35 Million in Milestones from GSK

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iTeos Therapeutics announced the dosing of the first patient in its GALAXIES Lung-301 Phase 3 trial, testing the combination of belrestotug and dostarlimab against placebo and pembrolizumab in patients with advanced PD-L1 high NSCLC. The milestone has triggered a $35 million payment from GSK, iTeos' partner. This trial is the first to evaluate the TIGIT:PD-1 doublet therapy, informed by promising interim Phase 2 results. iTeos and GSK's collaboration, established in June 2021, included a $625 million upfront payment with potential milestone payments up to $1.45 billion and a profit-sharing agreement in the US.

Positive
  • Dosing the first patient in the GALAXIES Lung-301 Phase 3 trial.
  • $35 million milestone payment from GSK.
  • Potential milestone payments up to $1.45 billion.
  • Profit-sharing agreement with GSK in the US.
  • Exclusive development and commercialization collaboration with GSK.
Negative
  • None.

Dosing the first patient in a Phase 3 trial is a significant milestone in the clinical development process. Phase 3 trials are important as they provide the final data needed to evaluate the efficacy and safety of a new treatment. This study examines belrestotug combined with dostarlimab in patients with advanced or metastatic NSCLC, which is an aggressive type of lung cancer with limited treatment options.

From a clinical perspective, the initiation of this trial signifies progress in validating this immuno-oncology combination's potential as a new first-line treatment. The milestone payment of $35 million from GSK highlights their confidence in this development program and provides financial support for ongoing research. In the short-term, investors should watch for updates on patient enrollment and interim analysis results. Long-term, positive outcomes could significantly impact iTeos' market position and its science-driven approach could lead to further partnerships.

The milestone payment of $35 million from GSK adds immediate financial strength to iTeos, helping to offset the costs of their R&D activities. Promising milestones are structured into their wider $2 billion collaboration with GSK, including an upfront payment of $625 million and potential regulatory and commercial milestones worth up to $1.45 billion.

Such payments reduce financial risk and give the company a more solid runway to fund further trials and operations. Furthermore, the potential for iTeos to receive tiered royalty payments outside the US can create a sustainable revenue stream in the long term. Investors should consider the strength of iTeos' cash position and the strategic partnership with a major pharmaceutical player like GSK, which adds considerable credibility and resources.

The partnership with GSK positions iTeos well within the competitive landscape of immuno-oncology. The TIGIT (T cell immunoreceptor with Ig and ITIM domains) pathway is an emerging area of research and iTeos' combination therapy approach could offer a novel treatment for PD-L1 high NSCLC patients. The market for advanced lung cancer therapies is significant, with substantial unmet medical need, which presents a considerable market opportunity.

Investors should be aware of the competitive dynamics, as other companies are also developing therapies targeting the TIGIT pathway. Yet, the initiation of a Phase 3 trial and the structured milestone payments illustrate a data-driven strategy with strong potential. If successful, this trial could position iTeos and GSK as leaders in the next-generation immuno-oncology treatments, potentially shifting treatment paradigms and capturing market share.

WATERTOWN, Mass. and GOSSELIES, Belgium, July 08, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced the dosing of the first patient in GALAXIES Lung-301, a global, randomized, double-blind Phase 3 registrational clinical trial of belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC. This event has triggered $35 million in development milestone payments from GSK, its partner for belrestotug.

“Dosing the first patient in the GALAXIES Lung-301 study marks a significant milestone for belrestotug + dostarlimab. iTeos was founded with the goal of advancing therapeutic options for patients by leveraging best-in-class science. The decision to launch our first TIGIT:PD-1 doublet Phase 3 trial underscores our disciplined, data-driven investment approach and was informed by several promising preliminary clinical surrogates such as safety, ORR, and depth of response from the latest interim analysis in May 2024,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “We are excited about the ongoing Phase 2 GALAXIES Lung-201 trial and look forward to presenting data from the most recent interim analysis of this study at a medical meeting in 2024.”

iTeos and GSK entered into an exclusive development and commercialization collaboration in June 2021 for belrestotug, an anti-TIGIT monoclonal antibody, enabling novel next-generation immuno-oncology combinations. Per the agreement, iTeos received a $625 million upfront payment from GSK with development and regulatory milestones up to $550 million and commercial milestones up to $900 million. In addition to the milestones, GSK and iTeos will jointly commercialize and equally split profits in the US. Outside the US, GSK will receive an exclusive license for commercialization and iTeos will receive tiered royalty payments. Within the collaboration, GSK and iTeos share responsibility and costs for the global development of belrestotug.

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 immunosuppressive 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.

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 our product candidates and the expectation to present data from the most recent interim analysis of the Phase 2 GALAXIES Lung-201 trial at a medical meeting in 2024.

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: success in 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 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 challenges and uncertainties inherent in product research and development and manufacturing limitations; and those risks identified under the heading “Risk Factors” in iTeos’ Quarterly Report on Form 10-Q for the period ended March 31, 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.

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

What is the GALAXIES Lung-301 trial?

The GALAXIES Lung-301 trial is a Phase 3 clinical study testing the combination of belrestotug and dostarlimab versus placebo and pembrolizumab in patients with advanced PD-L1 high NSCLC.

What milestone payment did iTeos receive from GSK?

iTeos received a $35 million milestone payment from GSK after dosing the first patient in the GALAXIES Lung-301 trial.

When did iTeos and GSK enter into their collaboration agreement?

iTeos and GSK entered into their exclusive development and commercialization collaboration in June 2021.

What are the potential milestone payments iTeos could receive from GSK?

iTeos could receive up to $1.45 billion in development, regulatory, and commercial milestone payments from GSK.

What is the significance of the GALAXIES Lung-301 trial for iTeos?

The GALAXIES Lung-301 trial is significant as it marks the company's first Phase 3 trial evaluating the TIGIT:PD-1 doublet therapy, supported by promising interim Phase 2 results.

iTeos Therapeutics, Inc.

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