iTeos Provides Clinical Development Plans and Promotes Yvonne McGrath, Ph.D. to Chief Scientific Officer

Rhea-AI Summary

iTeos Therapeutics (Nasdaq: ITOS) announced its clinical development plan for EOS-448, an anti-TIGIT monoclonal antibody, and inupadenant, an A_2A receptor antagonist. The company is progressing with 11 clinical studies, including three planned registration-directed trials. EOS-448 is being investigated in combination therapies with anti-PD-1 agents, while inupadenant is evaluated with chemotherapy and pembrolizumab. Yvonne McGrath has been promoted to chief scientific officer, crucial for advancing iTeos’s immunotherapy pipeline targeting difficult-to-treat cancers.

Positive

• Initiating 11 clinical studies, including three registration-directed trials.
• Encouraging Phase 1 data for EOS-448 and inupadenant.
• Promoted Yvonne McGrath to chief scientific officer, enhancing leadership in R&D.

Negative

• None.

CAMBRIDGE, Mass. and GOSSELIES, Belgium, Jan. 10, 2022 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, today provided a clinical development plan for its anti-TIGIT monoclonal antibody, EOS-448, and its A_2A receptor antagonist, inupadenant. iTeos also announced the promotion of Yvonne McGrath, Ph.D., to chief scientific officer.

“We have generated significant momentum for both of our clinical programs that have shown encouraging Phase 1 data: EOS-448, our FcγR-engaging anti-TIGIT antibody and inupadenant, our potential best-in-class A_2A receptor antagonist. We are entering a period of execution from a clinical development perspective, with 11 clinical studies ongoing or expected to start, including three planned registration-directed trials and novel immunotherapy combinations in difficult-to-treat cancers,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “I am also thrilled to announce Dr. McGrath’s promotion to chief scientific officer. Her leadership in our drug discovery and translational initiatives and deep knowledge of tumor immunology, have resulted in iTeos making tremendous progress in building a differentiated pipeline of next generation immunotherapies and identifying opportunities for new programs to take into the clinic. We look forward to continuing this momentum and providing updates on our ongoing trials as they progress, remaining focused on delivering potential therapies to patients as safely and quickly as possible.”

Clinical Development Plans

EOS-448: IgG1 anti-TIGIT monoclonal antibody designed to optimize its affinity, potency and activity, engage the Fc gamma receptor (FcγR), and to enhance the anti-tumor response through a multifaceted mechanism.

• iTeos plans to initiate various combinations of potential next generation immuno-oncology agents:
  • In partnership with GSK, the company is assessing the doublet of GSK’s anti-PD-1 (dostarlimab) with EOS-448 in 1L PDL1^high non-small cell lung cancer, head and neck squamous cell carcinoma and an additional indication in registration-directed trials. The companies are also initiating trials with novel triplets, including dostarlimab with EOS-448 and inupadenant as well as EOS-448 with dostarlimab and GSK’s anti-CD96 antibody, GSK’608.
  • iTeos is examining the doublet of pembrolizumab with EOS-448 in patients with solid tumors in an ongoing Phase 1 trial and inupadenant with EOS-448 in PD-1 resistant melanoma in an ongoing Phase 2a trial.
  • The company is advancing an ongoing open-label, multicenter, dose-escalation/expansion Phase 1/2 trial evaluating the safety, tolerability and preliminary activity of EOS-448, to the combination phase with Bristol Myers Squibb’s immunomodulatory imide drug (IMiD), iberdomide, with or without dexamethasone, in adults with relapsed or refractory multiple myeloma, based on strong preclinical data generated with Fred Hutchinson Cancer Research Center.

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 different immune cells found in the tumor micro-environment.

• iTeos plans to initiate a randomized Phase 2 trial in a solid tumor indication to evaluate the combination of inupadenant with chemotherapy compared to standard of care.
• The company is also evaluating inupadenant in combination with pembrolizumab in PD-1 resistant melanoma in an ongoing Phase 2a trial.
• iTeos is evaluating patient and indication selection biomarkers in the ongoing Phase 1b/2a trial of inupadenant as a monotherapy.
  

In the role of chief scientific officer, Dr. McGrath will be responsible for the continued advancement of iTeos’s pipeline of immunotherapy candidates in advanced cancers. She has served as vice president of R&D since June 2020, bringing more than 20 years of experience in immuno-oncology, clinical development and R&D. Prior to iTeos, Dr. McGrath served as the chief scientific officer at Complix N.V. and as Head of Development at Immunocore. She also held R&D management positions at Medigene and Biovex. Dr. McGrath holds a Ph.D. from the University of Wales, College of Medicine, UK.

“iTeos is deeply committed to making a difference for people with cancer through the development of a growing pipeline of candidates and original approaches, designed with the potential to fully restore the immune response against cancer,” said Dr. McGrath. “I am excited to continue to lead our team of R&D scientists during this pivotal time for the company, applying our deep knowledge of tumor immunology to design and develop best-in-class therapeutics for patients.”

About iTeos Therapeutics, Inc.
iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated 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 fully 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 Cambridge, 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 within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements that are not 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. Forward-looking statements include statements relating to the potential benefits of our product candidates, including their potential to restore the immune response against cancer and the potential of A_2A to be best-in-class receptor antagonist; our clinical trials plans; and the potential for certain studies to support regulatory submissions.

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 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 to support regulatory approval; the expected benefits and opportunities related to the agreement between iTeos and GSK may not be realized or may take longer to realize than expected 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 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’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 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 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 based on events or circumstances after the date hereof.

For further information, please contact:

Investor Contacts:
Ryan Baker
iTeos Therapeutics, Inc.
Ryan.Baker@iteostherapeutics.com

Media Contacts:
media@iteostherapeutics.com

FAQ

What is the purpose of iTeos Therapeutics' EOS-448 clinical trial?

The EOS-448 trial aims to evaluate the efficacy of the anti-TIGIT monoclonal antibody in combination with other therapies for various cancers.

What are the key features of the inupadenant clinical trial?

Inupadenant is tested in a randomized Phase 2 trial, assessing its combination with chemotherapy against standard care in solid tumors.

When was Yvonne McGrath appointed as chief scientific officer?

Yvonne McGrath's promotion to chief scientific officer was announced in the January 10, 2022 press release.

How many clinical studies is iTeos currently conducting?

iTeos is conducting 11 clinical studies across its pipeline.

How does EOS-448 work in treating cancer?

EOS-448 is designed to enhance the anti-tumor response through a multifaceted mechanism by engaging the Fc gamma receptor.