1. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Sept. 01, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (NASDAQ:ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immune-oncology therapeutics for patients, today announced that company management will participate in five upcoming virtual investor conferences in September:

    • KBC Securities Life Sciences Conference
      Format: Management one-on-ones
      Date: September 7, 2021
    • Wells Fargo Virtual Healthcare Conference
      Format: Management one-on-ones
      Date: September 9-10, 2021
    • Morgan Stanley 19th Annual Global Healthcare Conference
      Format: Management one-on-ones
      Date: September 9-10 and 13-15, 2021
    • H.C. Wainwright 23rd Annual Global

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Sept. 01, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (NASDAQ:ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immune-oncology therapeutics for patients, today announced that company management will participate in five upcoming virtual investor conferences in September:

    • KBC Securities Life Sciences Conference

      Format: Management one-on-ones

      Date: September 7, 2021
    • Wells Fargo Virtual Healthcare Conference

      Format: Management one-on-ones

      Date: September 9-10, 2021
    • Morgan Stanley 19th Annual Global Healthcare Conference

      Format: Management one-on-ones

      Date: September 9-10 and 13-15, 2021
    • H.C. Wainwright 23rd Annual Global Investment Conference

      Format: On demand presentation by Michel Detheux, Ph.D., President and Chief Executive Officer

      Date/Time: Monday, September 13, 2021 at 7:00 a.m. ET
    • Cantor Fitzgerald Global Healthcare Conference

      Format: Live presentation by Michel Detheux, Ph.D., President and Chief Executive Officer

      Date/Time: Monday, September 27, 2021 at 2:40 p.m. ET

    Audio webcasts of the presentations will be available on the Investor section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    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. The Company's innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology. The initial 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. An open-label Phase 1 clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating preliminary clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a first insurmountable adenosine A2A receptor antagonist in clinical development tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity as well as the identification of a potential predictive biomarker. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contact:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contact:

    media@iteostherapeutics.com

     



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    • Announced co-development and co-commercialization collaboration with GSK for anti-TIGIT monoclonal antibody EOS-448 (GSK'859); $625MM upfront payment in addition to $1.45B in potential milestones, 40/60 cost-sharing of global development, 50/50 profit share in the US, and royalty payments on ex-US sales
    • Presented initial clinical data for EOS-448 at AACR 2021 demonstrating target engagement, promising early monotherapy anti-cancer activity and tolerability at all dose levels
    • Updated data from Phase 1/2a trial of inupadenant (EOS-850) presented at ASCO 2021 show evidence of durable monotherapy anti-cancer activity, and a correlation between the expression of A2AR and clinical outcomes
    • Cash balance of $302.9MM as of June 30, 2021; Subsequent to June
    • Announced co-development and co-commercialization collaboration with GSK for anti-TIGIT monoclonal antibody EOS-448 (GSK'859); $625MM upfront payment in addition to $1.45B in potential milestones, 40/60 cost-sharing of global development, 50/50 profit share in the US, and royalty payments on ex-US sales
    • Presented initial clinical data for EOS-448 at AACR 2021 demonstrating target engagement, promising early monotherapy anti-cancer activity and tolerability at all dose levels
    • Updated data from Phase 1/2a trial of inupadenant (EOS-850) presented at ASCO 2021 show evidence of durable monotherapy anti-cancer activity, and a correlation between the expression of A2AR and clinical outcomes
    • Cash balance of $302.9MM as of June 30, 2021; Subsequent to June 30, received $625MM upfront payment from GSK, providing cash runway into 2026
    • Company to host conference call today at 8:00am ET

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Aug. 12, 2021 (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 reported financial results for the second quarter ended June 30, 2021 and provided recent business highlights.

    "The last few months have been a transformative time for iTeos, as we achieved significant milestones that will shape the future of our company and help us in our mission to discover, develop and deliver therapies that will improve the lives of people with cancer. I am incredibly proud of our continued execution with our clinical programs and strategic initiatives," said Michel Detheux, PhD, president, and chief executive officer of iTeos. "For our TIGIT program, we announced a transformational strategic collaboration with GSK that will allow us to combine our resources and expand and accelerate the development program for EOS-448 through rapid evaluation of dostarlimab and triplet combinations beginning in the coming months. With the rights iTeos retained, we can maximize the value of EOS-448 for patients and our shareholders. In addition to expanding our TIGIT program, the GSK collaboration is also an important validation for our team's ability to identify and pursue best-in-class anti-tumor drug candidates. To that end, we are excited to advance inupadenant, our second clinical-stage program, which has demonstrated in a Phase 1 trial durable responses in two patients with checkpoint inhibitor resistant tumors, good tolerability and a potentially predictive biomarker which will help to drive tumor and patient selection in upcoming trials. In the coming months, we look forward to advancing inupadenant into proof-of-concept trials in several indications."

    Program Highlights

    EOS-448: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance anti-tumor responses through a multifaceted mechanism of action.

    • In June 2021, iTeos and GSK announced an agreement to co-develop and co-commercialize EOS-448. As part of the agreement, iTeos received a $625 million upfront payment and is eligible to receive up to $1.45 billion in potential milestone payments upon the achievement of certain development and commercial milestones. GSK is responsible for 60% of expense in the global development plan. The companies will co-commercialize and equally split profits in the U.S. iTeos will be eligible to receive royalties on sales outside of the U.S.
    • In April 2021, the Company presented initial clinical and safety data from the monotherapy dose escalation part of the Phase 1 trial in adult patients with advanced solid tumors at the American Association for Cancer Research (AACR) Annual Meeting. These preliminary data show the drug was well-tolerated across dose levels, caused depletion of TIGIT-expressing Treg cells in the blood, providing evidence of target and FcyR engagement, and had encouraging early signs of anti-cancer activity in Phase 1, including one partial response in a pembrolizumab-resistant metastatic melanoma patient.
    • The Company is working with GSK to rapidly initiate trials of EOS-448 in combinations including with Jemperli (dostarlimab).
    • iTeos will also advance EOS-448 in combination with pembrolizumab and with inupadenant in patients with solid tumors, and as a monotherapy and in combination with an Immunomodulatory Drug (IMiD) in patients with multiple myeloma.

    Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on different immune cells found in the tumor micro-environment.

    • In June 2021, the company presented updated data from 43 patients in both the single-agent dose-escalation and expansion portions of the ongoing open-label Phase 1/2a clinical trial, including results from pre-treatment tumor biopsy analyses, as part of an e-poster at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary tumor biopsy analyses demonstrate that A2AR expression assessed using a proprietary assay, in patients with solid tumors treated with single agent inupadenant is associated with clinical outcomes. Results also provide evidence of durable antitumor activity in patients with advanced solid tumors and indicate a safety and tolerability profile consistent with previously reported data.
    • Based on the encouraging monotherapy results, iTeos plans to initiate inupadenant proof-of-concept trials in several indications and will continue to use A2AR and other potential biomarkers to select indications and patients most likely to benefit from treatment.

    Preclinical programs: iTeos continues to progress research programs focused on additional targets that address pathways of immunosuppression and complement the mechanism of action of the A2AR and TIGIT programs. iTeos expects to nominate an additional product candidate which inhibits a novel target in the adenosine pathway for Investigational New Drug-enabling studies before the end of 2021.

    Upcoming Events

    • KBC Securities Life Sciences Conference, September 7
    • Wells Fargo Healthcare Conference, September 9-10
    • Morgan Stanley Global Healthcare Conference, September 9-10 and 13-15
    • H.C. Wainwright Global Investment Conference, September 13-15
    • Cantor Fitzgerald Global Healthcare Conference, September 27-30

    Second Quarter 2021 Financial Results

    • Cash Position: The Company had cash and cash equivalents of $302.9 million as of June 30, 2021, compared to $136.9 million as of June 30, 2020. Following receipt of the upfront payment from GSK pursuant to the Company's Collaboration and License Agreement earlier in August 2021, the Company believes that its existing cash and cash equivalents would enable it to fund operating expenses and capital expenditure requirements into 2026.
    • Research and Development (R&D) Expenses: R&D expenses were $14.2 million for the quarter ended June 30, 2021, compared to $6.1 million for the same quarter of 2020. This increase was primarily due to an increase in activities related to clinical trials for EOS-448 and inupadenant and increased headcount.
    • General and Administrative (G&A) Expenses: G&A expenses were $15.1 million for the quarter ended June 30, 2021, compared to $2.4 million for the same quarter of 2020. This increase was primarily due to increased headcount, professional fees and other costs associated with becoming a public company, along with one-time legal and advisory fees incurred by the Company associated with the Collaboration and License Agreement with GSK to co-develop and co-commercialize EOS-448.
    • Net Loss: Net loss attributable to common shareholders was $26.5 million, or a net loss of $0.75 per basic and diluted share, for the quarter ended June 30, 2021, as compared to $10.3 million, or a net loss of $29.49 per basic and diluted share, for the same quarter of 2020.

    Conference Call Details:

    iTeos Therapeutics will host a conference call and webcast today at 8:00am ET. To access the live event, please use the following link and you will receive access details via email: https://www.incommglobalevents.com/registration/q4inc/8354/iteos-therapeutics-q2-2021-earnings-conference-call/

    A live audio webcast of the event will also be accessible from the Events page of the Company's website at https://investors.iteostherapeutics.com/news-and-events/events. The archived webcast will be available approximately two hours after the completion of the event and for 30 days following the call.

    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 cancer 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 A2A 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.

    Forward-Looking Statements

    In order to provide iTeos' investors with an understanding of its current results and future prospects, this press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "may," "intends," "prepares," "looks," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to our future operations, financial performance and projections, business plans, market opportunities, priorities and research and development programs and expected plans and milestones, including milestones and royalty payments from GSK pursuant to the collaboration agreement; GSK's obligation to share responsibility and costs for the global development of EOS-448; the collaboration with GSK allowing us to combine our resources and expand and accelerate the development program for EOS-448 through rapid evaluation of dostarlimab and triplet combinations; the plan to initiate studies for EOS-448 in the coming months; the collaboration with GSK allowing us to maximize the value of EOS-448 for patients and our shareholders; our plan to initiate inupadenant proof-of-concept trials in several indications and to continue to use A2AR and other potential biomarkers to select indications and patients most likely to benefit from treatment; our plan to nominate an additional product candidate which inhibits a novel target in the adenosine pathway for Investigational New Drug-enabling studies before the end of 2021; and the expectation that iTeos' existing cash and cash equivalents would enable iTeos to fund its operating expenses and capital expenditure requirements into 2026.

    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 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 encounter unanticipated costs or may expend cash more rapidly 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; 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 June 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. 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 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



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  2. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Aug. 05, 2021 (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 announced that it will host a conference call and live webcast at 8:00 a.m. ET on Thursday, August 12, 2021 to report its second quarter 2021 financial results and provide a corporate update.

    To pre-register for the call, please use the following link, and you will receive access details via email.

    Webcast

    This registration link, along with a live audio webcast, will be accessible from the Events page of the Company's IR website at https://investors.iteostherapeutics.com/news-and-events/events

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Aug. 05, 2021 (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 announced that it will host a conference call and live webcast at 8:00 a.m. ET on Thursday, August 12, 2021 to report its second quarter 2021 financial results and provide a corporate update.

    To pre-register for the call, please use the following link, and you will receive access details via email.

    Webcast

    This registration link, along with a live audio webcast, will be accessible from the Events page of the Company's IR website at https://investors.iteostherapeutics.com/news-and-events/events. A replay will be available on the Company's website approximately two hours after completion of the event and for 30 days following the call

    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. The Company's innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology. The initial 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. An open-label Phase 1 clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating preliminary clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a first insurmountable adenosine A2A receptor antagonist in clinical development tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity as well as the identification of a potential predictive biomarker. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contact:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contacts:

    media@iteostherapeutics.com



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  3. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Aug. 03, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will present at the upcoming Wedbush PacGrow Healthcare Conference 2021 on Tuesday, August 10, 2021 at 2:20 p.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    About iTeos Therapeutics, Inc.

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Aug. 03, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will present at the upcoming Wedbush PacGrow Healthcare Conference 2021 on Tuesday, August 10, 2021 at 2:20 p.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    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. The Company's innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology. The initial 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. An open-label Phase 1 clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating preliminary clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a first insurmountable adenosine A2A receptor antagonist in clinical development tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity as well as the identification of a potential predictive biomarker. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contact:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contact:

    media@iteostherapeutics.com



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  4. CAMBRIDGE, Mass. and GOSSELIES, Belgium, July 08, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will participate in a panel discussion at the upcoming William Blair Biotech Focus Conference 2021 titled: "Developing Therapies for the Next IO Targets" on Wednesday, July 14, 2021 at 2:10 p.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for…

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, July 08, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will participate in a panel discussion at the upcoming William Blair Biotech Focus Conference 2021 titled: "Developing Therapies for the Next IO Targets" on Wednesday, July 14, 2021 at 2:10 p.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    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. The Company's innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology. The initial 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. An open-label Phase 1 clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating preliminary clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a first insurmountable adenosine A2A receptor antagonist in clinical development tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity as well as the identification of a potential predictive biomarker. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contact:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contact:

    media@iteostherapeutics.com



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    • EOS-448 is currently in phase I for advanced solid tumours with a randomised PD-1 combination study planned for 2022
    • iTeos to receive a $625 million upfront payment in addition to potential milestones, and royalty payments on ex-US sales
    • GSK and iTeos will co-commercialise and share profits in the US
    • GSK now has the leading portfolio of antibodies targeting the CD226 axis - a key target for next-generation immuno-oncology therapies

    GOSSELIES, Belgium and LONDON, June 14, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics (NASD: ITOS) and GlaxoSmithKline plc (NYSE:GSK) today announced an agreement to co-develop and co-commercialise EOS-448, an anti-TIGIT monoclonal antibody currently in phase I development as a potential treatment for patients with cancer…

    • EOS-448 is currently in phase I for advanced solid tumours with a randomised PD-1 combination study planned for 2022
    • iTeos to receive a $625 million upfront payment in addition to potential milestones, and royalty payments on ex-US sales
    • GSK and iTeos will co-commercialise and share profits in the US
    • GSK now has the leading portfolio of antibodies targeting the CD226 axis - a key target for next-generation immuno-oncology therapies

    GOSSELIES, Belgium and LONDON, June 14, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics (NASD: ITOS) and GlaxoSmithKline plc (NYSE:GSK) today announced an agreement to co-develop and co-commercialise EOS-448, an anti-TIGIT monoclonal antibody currently in phase I development as a potential treatment for patients with cancer. TIGIT, part of the CD226 checkpoint axis, has demonstrated potential as a promising target for the next generation of immuno-oncology therapies based on compelling preclinical data and a phase II randomised clinical trial. With this collaboration GSK is uniquely positioned with access to antibodies that synergistically target all three known CD226 checkpoints - TIGIT, CD96 and PVRIG.

    Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Immuno-oncology has transformed cancer care but unfortunately less than 30 percent of patients respond to treatment with the current leading immune checkpoint inhibitors. Based on the underlying science, we believe that combinations of a PD-1, TIGIT, CD96 and PVRIG inhibitor could become transformative medicines for many patients with cancer. We are excited to collaborate with the team at iTeos and together we can play a leading role in the next generation of immuno-oncology therapies."

    Since GSK validated the role of CD226 axis targets as important in oncology, it has been strategically building a carefully constructed set of assets to target this network of checkpoint inhibitors. The addition of EOS-448 results in GSK being the only company with antibodies targeting all three known checkpoints – TIGIT (via EOS-448), CD96 (via GSK'608), and PVRIG (via GSK'562). Together with GSK's recently approved anti-PD-1, Jemperli (dostarlimab), this comprehensive portfolio of potential next generation immuno-oncology agents will be explored through various novel combinations, including doublets and triplets, to evaluate their potential to transform treatment options for patients with multiple different cancers.

    Michel Detheux, President and CEO, iTeos, said: "Through this transformative collaboration, iTeos now has access to GSK's best-in-class resources which will provide us with a significant advantage in a highly competitive, global market. We have chosen GSK because of their commercial capabilities, experience in immuno-oncology and their commitment to invest in the rapid advancement of our TIGIT programme and create a clear path forward for EOS-448. Inspired by the multifaceted mechanism of action of EOS-448 and promising early results in clinical trials, this collaboration allows us to accelerate and expand the clinical development of EOS-448. We are more confident than ever in our ability to succeed. This collaboration validates our science and provides a catalyst for the future of iTeos. The collaboration with GSK will allow our team to continue to develop next generation immunotherapies starting with inupadenant, our highly differentiated clinical-stage A2A adenosine receptor antagonist, and to drive scientific innovation with our expertise in tumour immunology to build our pipeline."

    EOS-448 is currently in an open-label phase I study in patients with advanced solid tumours. GSK and iTeos plan to start combination studies of EOS-448 with dostarlimab in 2022. GSK'608 (anti-CD96 being developed in collaboration with 23andMe) is in phase I as monotherapy and in combination with dostarlimab. GSK expects to submit an Investigational New Drug application for GSK'562 (anti-PVRIG in-licensed as SRF-813 from Surface Oncology) by mid-2022.

    Under the terms of the collaboration agreement, iTeos will receive an upfront payment of $625 million. iTeos will be eligible to receive up to an additional $1.45 billion in milestone payments, should the EOS-448 programme achieve certain development and commercial milestones.

    Within the collaboration, GSK and iTeos will share responsibility and costs for the global development of EOS-448 and will jointly commercialise and equally split profits in the US. Outside of the US, GSK will receive an exclusive license for commercialisation and iTeos will receive tiered royalty payments.

    The collaboration agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

    Conference Call Details

    iTeos will host a conference call to discuss the agreement today, Monday, June 14 at 8:30 a.m. ET. Details are as follows:

    Participant Dial-In: (833) 607-1661

    International Dial-In: (914) 987-7874

    Conference ID: 4598012

    Webcast: https://edge.media-server.com/mmc/p/xz7hasbz

    The live audio webcast will also be accessible from the Events page of the Company's IR website at https://investors.iteostherapeutics.com/news-and-events/events. A replay will be available on the Company's website approximately two hours after completion of the event and for 30 days following the call.

    GSK in Oncology

    GSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

    About GSK

    GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.

    About EOS-448

    EOS-448 is a monoclonal human IgG1 antibody designed to bind with high affinity TIGIT, a negative co-stimulatory immune checkpoint expressed T cells and NK cells. EOS-448 potently triggers an antitumor response by the immune system via a multi-faceted mechanism. By binding to TIGIT, EOS-448 blocks its interaction with TIGIT ligands including CD155 and CD112, which can then bind to CD226 and activate immune response of T cells and NK cells. In addition, IgG1 binds to FcγR to trigger pro-inflammatory cytokine release, activation of antigen presenting cells and depletion of TIGIT+ Tregs and exhausted T cells. In a phase 1 dose escalation, presented at AACR 2021, EOS-448 showed a favorable tolerability profile and early signs of clinical activity in advanced cancers with one confirmed partial response and 9 stable diseases out of 20 evaluable patients with advanced, difficult to treat cancers. Depletion of TIGIT+ suppressive and exhausted cells were shown at even the lowest tested dose thereby providing evidence of engagement of the FcγR, and the potential of EOS-448 to activate multiple immune mechanisms. This program was funded by a SPW/EER grant.

    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. The Company's innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology. The initial 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. An open-label Phase 1 clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating preliminary clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a first insurmountable adenosine A2A receptor antagonist in clinical development tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity as well as the identification of a potential predictive biomarker. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    iTeos Therapeutics, Inc. Forward-Looking Statements

    This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include but are not limited to statements regarding the closing of the transaction; iTeos' right to receive any upfront payment, milestones and royalty payments from GSK pursuant to the agreement and GSK's obligation to share responsibility and costs for the global development of EOS-448; EOS-448's potential as a promising target for the next generation of immuno-oncology therapies; the potential of combinations of TIGIT, CD96 and PVRIG to become transformative medicines for many patients with cancer; GSK's best-in-class resources providing iTeos with a significant advantage in a highly competitive global market; the potential of the collaboration with GSK to accelerate and expand the clinical development of EOS-448; iTeos' plan to continue to develop next generation immunotherapies starting with inupadenant; and GSK and iTeos' plan to start combination studies of EOS-448 with dostarlimab in 2022.   

    These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements.  Many of these risks and uncertainties are beyond iTeos' control. Known risk factors include, among others, 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 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; 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 EOS-448 may not be sufficient for obtaining regulatory approval; 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 most recent Annual Report on Form 10-K for the year ended December 31, 2020 and most recent Quarterly Report on Form 10-Q 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 the Company's 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. 

    GSK enquiries:   
    Media enquiries:Simon Steel+44 (0) 20 8047 5502(London)
     Tim Foley+44 (0) 20 8047 5502(London)
     Kristen Neese+1 804 217 8147(Philadelphia)
     Kathleen Quinn+1 202 603 5003(Washington DC)
        
    Analyst/Investor enquiries:James Dodwell+44 (0) 20 8047 2406(London)
     Sonya Ghobrial+44 (0) 7392 784784(Consumer)
     Mick Readey+44 (0) 7990 339653(London)
     Jeff McLaughlin+1 215 751 7002(Philadelphia)
     Frannie DeFranco+1 215 751 4855(Philadelphia)

    iTeos enquiries:

    Media contact: media@iteostherapeutics.com

    Investor contact: Ryan Baker; Ryan.Baker@iteostherapeutics.com

    Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

     



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    • Updated results from a dataset of 43 patients showed durable responses and stable disease greater than six months with inupadenant monotherapy in five patients with advanced solid tumors, including previously reported confirmed partial responses in patients with checkpoint-inhibitor resistant melanoma and heavily pretreated castrate-resistant prostate cancer, and a newly reported patient with heavily pretreated non-small cell lung cancer who had stable disease lasting more than 10 months
    • Preliminary analyses of tumor biopsies indicated that the expression of A2A receptor in pre-treatment tumor samples is associated with clinical outcome in patients with solid tumors treated with single agent inupadenant
    • Single-agent administration of inupadenant

    • Updated results from a dataset of 43 patients showed durable responses and stable disease greater than six months with inupadenant monotherapy in five patients with advanced solid tumors, including previously reported confirmed partial responses in patients with checkpoint-inhibitor resistant melanoma and heavily pretreated castrate-resistant prostate cancer, and a newly reported patient with heavily pretreated non-small cell lung cancer who had stable disease lasting more than 10 months
    • Preliminary analyses of tumor biopsies indicated that the expression of A2A receptor in pre-treatment tumor samples is associated with clinical outcome in patients with solid tumors treated with single agent inupadenant
    • Single-agent administration of inupadenant was well tolerated, consistent with the previously reported safety data
    • Company will continue to evaluate inupadenant and the A2A receptor biomarker in ongoing Phase 1b/2a trial in combination with pembrolizumab and in combination with chemotherapy

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, June 04, 2021 (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 announced new clinical data from its ongoing Phase 1/2a clinical trial of inupadenant (EOS-850), a next-generation adenosine receptor (A2AR) antagonist, at the American Society of Clinical Oncology (ASCO) Annual Meeting 2021. Updated results from the single-agent dose-escalation and expansion portions of the trial provided evidence of durable antitumor activity in patients with advanced solid tumors and indicated safety consistent with previously reported results. Three serious adverse events considered possibly related to treatment with inupadenant had plausible alternate causes and do not represent a new safety concern for the program. Additionally, preliminary analyses of pre-treatment tumor biopsies indicated that the expression of A2AR is associated with clinical outcomes in patients with solid tumors treated with single agent inupadenant.

    "We are pleased with the durability of the anti-tumor responses we have observed to date with our highly selective A2AR antagonist, inupadenant, in patients with advanced cancers. These early-stage results support the development for the treatment of cancer of inupadenant, a selective inhibitor of A2AR, which is known to play a crucial role in immunosuppression in the tumor microenvironment." said Joanne Jenkins Lager, M.D., chief medical officer of iTeos Therapeutics. "We have used a proprietary assay to identify A2AR expression as a biomarker that may be predictive of clinical benefit. These new biomarker findings provide insight into the mechanism of action of inupadenant, informing our selection of potential indications, and may allow us to identify patients more likely to benefit from inupadenant. We are continuing to evaluate combinations with pembrolizumab and chemotherapy in our ongoing Phase 1b/2a trial with the goal of improving outcomes for patients."

    Phase 1/2a monotherapy Study Design and Results

    The ongoing Phase 1/2a trial is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of inupadenant monotherapy to define the maximum tolerated dose (MTD) and recommended Phase 2 dose of inupadenant as a single agent and in combination with pembrolizumab and/or chemotherapy in patients with advanced solid tumors. As of the data cut-off (February 26, 2021), 43 patients had enrolled in the single-agent dose-escalation and expansion parts of the study.

    Results presented at ASCO 2021 provided an update on 21 patients enrolled in the single-agent dose-escalation and new data on 22 patients enrolled in the dose expansion.

    Durable responses and stable disease greater than six months were observed in five patients with advanced solid tumors, including:

    • previously reported partial responses: ongoing for more than 12 months in one patient with castrate-resistant prostate cancer, and lasting for more than 8 months in one patient with melanoma resistant to both pembrolizumab and ipilimumab; and
    • stable disease in a patient with non-small cell lung cancer enrolled in the expansion, with ongoing treatment for more than 10 months.

    The safety of inupadenant monotherapy was consistent with previously presented data. The most frequent adverse events were fatigue, anemia, decreased appetite and constipation. Drug-related serious adverse events (acute myocardial infarction, atrial fibrillation, and pericardial effusion) were reported in three of the 43 enrolled patients.

    Evaluation of pre-treatment biopsies indicated that higher expression of A2AR was associated with longer survival and either tumor regression or stable tumor size in patients with solid tumors treated with single agent inupadenant.

    The e-poster and abstract can be accessed on the ASCO conference website. The abstract and presentation details are as follows:

    Title: Phase 1 trial of the adenosine A2A receptor antagonist inupadenant (EOS-850): Update on tolerability, and antitumor activity potentially associated with the expression of the A2A receptor within the tumor.

    Session Title: Developmental Therapeutics—Immunotherapy

    Abstract #: 2562

    Authors: Laurence Buisseret, et al.

    Further Clinical Development of Inupadenant

    Based on the promising Phase 1/2a data to date, iTeos plans to further evaluate inupadenant in combination with pembrolizumab and in combination with chemotherapy in Phase 1b/2 studies, with an initial focus on patients with castrate-resistant prostate cancer, anti-PD-1-resistant melanoma and triple negative breast cancer. iTeos will continue to evaluate A2AR and other potential predictive biomarkers in the inupadenant clinical development program to ensure optimal therapeutic combinations and identify patients most likely to benefit from treatment.

    About Inupadenant

    Elevated levels of adenosine found in the tumor microenvironment are known to be immunosuppressive, by inhibiting A2AR, the only high-affinity adenosine receptor expressed on different immune cells found in the tumor micro-environment. Inupadenant (EOS-850) is the first insurmountable A2AR antagonist tailored for application in immuno-oncology, currently in clinical development. Inupadenant was designed by iTeos' scientists to remain potent at the high adenosine concentrations found in the tumor micro-environment and maintain continuous target coverage in multiple tumor types. Inupadenant has a very high selectivity for A2AR compared to the other adenosine receptors and is non brain penetrant, two characteristics that should improve its safety. With this profile, we believe that inupadenant has the potential for enhanced antitumor activity as compared to other A2AR antagonists currently in clinical development.

    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 the tumor microenvironment 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 initial 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. An open-label Phase 1/2a clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a next-generation adenosine A2A receptor antagonist tailored to overcome cancer immunosuppression. iTeos is conducting an open-label, multi-arm Phase 1/2a clinical trial of inupadenant as a single-agent and in combinations in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity in the dose escalation portion of the trial. iTeos Therapeutics is headquartered in Cambridge, MA, with a research center in Gosselies, Belgium.

    Forward-Looking Statements

    This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding the Company's future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting clinical data, projections regarding our long-term growth, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our clinical programs, as well as other statements containing words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions that can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from pre-clinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; whether the Company will receive regulatory approvals to conduct trials or to market products; whether the Company's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on the Company's business, operations, strategy, goals and anticipated timelines, the Company's ongoing and planned pre-clinical activities, the Company's ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, the Company's timelines for regulatory submissions and the Company's financial position; and other risks concerning the Company's programs and operations set forth under the caption "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed on May 13, 2021, as updated by its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither the Company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    For further information, please contact:

    Investor Contact:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contact:

    media@iteostherapeutics.com



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  5. CAMBRIDGE, Mass. and GOSSELIES, Belgium, May 26, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 8:00 a.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    About iTeos Therapeutics, Inc.

    iTeos Therapeutics…

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, May 26, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 8:00 a.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    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 cancer 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 initial 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. An open-label Phase 1/2a clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating preliminary clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a next-generation adenosine A2A receptor antagonist tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity in the dose escalation portion of the trial. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contacts:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contacts:

    media@iteostherapeutics.com



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  6. - Presented differentiated clinical and pharmacodynamic data from Phase 1/2a trial of anti-TIGIT antibody, EOS-448, at AACR 2021; expansion into combination cohorts expected mid-2021 -

    - Inupadenant updated monotherapy clinical data and evidence of association of A2A receptor expression with anti-tumor activity to be presented at the ASCO 2021 Annual Meeting in June -

    - Strong cash balance of $321.4 million to support clinical advancements and continued investment in discovery efforts to expand pipeline -

    - Company to host conference call today at 4:30 p.m. ET -

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, May 13, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (NASDAQ:ITOS), a clinical-stage biopharmaceutical company pioneering the discovery…

    - Presented differentiated clinical and pharmacodynamic data from Phase 1/2a trial of anti-TIGIT antibody, EOS-448, at AACR 2021; expansion into combination cohorts expected mid-2021 -

    - Inupadenant updated monotherapy clinical data and evidence of association of A2A receptor expression with anti-tumor activity to be presented at the ASCO 2021 Annual Meeting in June -

    - Strong cash balance of $321.4 million to support clinical advancements and continued investment in discovery efforts to expand pipeline -

    - Company to host conference call today at 4:30 p.m. ET -

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, May 13, 2021 (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 reported financial results for the first quarter ended March 31, 2021 and provided recent business highlights.

    "Our current clinical strategy includes six studies for our two clinical programs in different indications and combinations that are expected to provide meaningful readouts before the end of 2022. In addition to our recent EOS-448 Phase 1 data presentation at AACR, we also continue to advance our adenosine A2A receptor antagonist, inupadenant, and we look forward to reporting updated data with evidence that expression of the A2A receptor in tumor biopsy samples is associated with anti-tumor benefit at the upcoming ASCO meeting in June," said Michel Detheux, PhD, president and chief executive officer of iTeos. "In addition to this progress across our two lead programs, we also remain committed to our ongoing discovery efforts to identify and advance new novel product candidates that could expand our pipeline and continue to serve our mission to improve the lives of people with cancer."

    Program Highlights

    EOS-448: EOS-448 is an IgG1 antibody with the ability to engage the Fc gamma receptor (FcγR) and to enhance the anti-tumor response through a multifaceted mechanism.

    • The company presented initial clinical and safety data from the monotherapy dose escalation part of the Phase 1 trial in adult patients with advanced solid tumors at the American Association for Cancer Research (AACR) Annual Meeting in April 2021. These preliminary data showed the drug was well-tolerated across dose levels, caused depletion of TIGIT-expressing Treg cells in the blood, providing evidence of target and FcyR engagement, and had encouraging signs of anti-cancer activity.



    • The company plans to advance EOS-448 into combination trials in both checkpoint-naïve and resistant patients in mid-2021. These Phase 1b trials will assess the safety of EOS-448 in combination with pembrolizumab and with iTeos' novel agent inupadenant in patients with solid tumors, and as a monotherapy and in combination with an Immunomodulatory Drug (IMiD) in patients with multiple myeloma.

    Inupadenant (EOS-850): Designed as a highly selective small molecule antagonist of the adenosine A2A receptor. Inupadenant is currently in an open-label multi-arm Phase 1/2a clinical trial in adult patients with advanced solid tumors.

    • iTeos is currently enrolling patients in three distinct cohorts in its Phase 1/2a clinical trial as both as a single agent and in combination. The initial cohort is evaluating inupadenant as a monotherapy in prostate cancer, and the second cohort is evaluating the safety of inupadenant in combination with pembrolizumab in patients with solid tumors with planned expansions in prostate cancer and melanoma. The final cohort is evaluating inupadenant in combination with chemotherapy in patients with triple-negative breast cancer.



    • iTeos plans to report updated single-agent data, including results from tumor biopsy analyses as part of an e-poster at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting held virtually June 4-8, 2021. The abstract will be available on Wednesday, May 19th at 5:00 p.m. ET, and the e-poster will be available for on-demand viewing starting on Friday, June 4 at 9:00 a.m. ET.



      Abstract Title: Phase 1 trial of the adenosine A2A receptor antagonist inupadenant (EOS-850): Update on tolerability, and antitumor activity potentially associated with the expression of the A2A receptor within the tumor.

      Abstract Number: 2562

    Preclinical programs: iTeos continues to progress research programs focused on additional targets that address additional pathways of immunosuppression and complement the mechanism of action of A2AR and TIGIT programs. iTeos expects to nominate an additional product candidate for Investigational New Drug-enabling studies before the end of 2021.

    Upcoming Events

    • Corporate presentation at the Jefferies Healthcare Conference, June 1-4, 2021
    • Present on inupadenant in an e-poster at the ASCO Annual Meeting, June 4-8, 2021
    • Corporate presentation at the Citi European Healthcare Conference, June 15-16, 2021

    First Quarter 2021 Financial Results

    • Cash Position: The Company had cash and cash equivalents of $321.4 million as of March 31, 2021, compared to $147.7 million as of March 31, 2020. This cash balance provides a runway into 2023.
    • Research and Development (R&D) Expenses: R&D expenses were $11.6 million for the quarter ended March 31, 2021, compared to $5.8 million for the same quarter of 2020. This increase was primarily due to an increase in activities related to clinical trials for inupadenant and EOS-448 and increased headcount.
    • General and Administrative (G&A) Expenses: G&A expenses were $7.0 million for the quarter ended March 31, 2021, compared to $2.4 million for the same quarter of 2020. The increase was primarily due to increased headcount and professional fees and other costs associated with becoming a publicly traded company.
    • Net Loss: Net loss attributable to common shareholders was $13.5 million, or a net loss of $0.39 per basic and diluted share, for the quarter ended March 31, 2021, as compared to $6.5 million, or a net loss of $25.53 per basic and diluted share, for the same quarter of 2020.

    Conference Call Details:

    iTeos Therapeutics will host a conference call and webcast today, Thursday, May 13th, at 4:30 p.m. ET. To access the live event, please dial the numbers and reference the conference ID listed below. A live audio webcast of the event will also be accessible from the Events page of the Company's website at https://investors.iteostherapeutics.com/news-and-events/events.The archived webcast will be available approximately two hours after the completion of the event and for 30 days following the call.

    Dial-in Numbers:

    (833) 607-1661 (US/Canada)

    (914) 987-7874 (International)

    Conference ID: 6160559

    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 cancer 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 initial 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. An open-label Phase 1/2a clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating preliminary clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a next-generation adenosine A2A receptor antagonist tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity in the dose escalation portion of the trial. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    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, including express or implied statements regarding iTeos' future expectations, plans and prospects, including statements regarding the Company's future expectations and plans for presenting clinical data, the anticipated timing of clinical trials and regulatory filings, and the development of product candidates and advancement of clinical programs, which are based on currently available information. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, future financial condition, future operations, prospects, plans, objectives of management and expected growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as ‘‘aim,'' ‘‘anticipate,'' ‘‘assume,'' ‘‘believe,'' ‘‘contemplate,'' ‘‘continue,'' ‘‘could,'' ‘‘design,'' ‘‘due,'' ‘‘estimate,'' ‘‘expect,'' ‘‘goal,'' ‘‘intend,'' ‘‘may,'' ‘‘objective,'' ‘‘plan,'' ‘‘predict,'' ‘‘positioned,'' ‘‘potential,'' ‘‘seek,'' ‘‘should,'' ‘‘target,'' ‘‘will,'' ‘‘would'' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about the initiation, timing, progress and results of our current and future clinical trials and current and future preclinical studies of our product candidates, including our clinical trials of inupadenant, our clinical trials of EOS-448 and of our research and development programs; uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical trials; the expected timing of announcing additional product candidates; the enrollment of our ongoing clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future clinical trials; our ability to successfully establish or maintain collaborations or strategic relationships for our product candidates; the expected timing for submissions for regulatory approval or review by governmental authorities; our financial performance; whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on our business, operations, strategies and anticipated timelines, including mitigation efforts and economic effects, including but not limited to our preclinical studies and future clinical trials; and our plans to develop and commercialize our current product candidates and any future product candidates and the implementation of our business model and strategic plans for our business, current product candidates and any future product candidates, and other risks concerning iTeos' programs and operations that are described in additional detail in our Annual Report on Form 10-K and our other filings made with the Securities and Exchange Commission from time to time. Although our forward-looking statements reflect the good faith judgment of management, these statements are based solely on facts and circumstances currently known to iTeos. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. iTeos undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, the occurrence of certain events or otherwise.

    For further information, please contact:

    Investor Contacts:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contacts:

    media@iteostherapeutics.com



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  7. CAMBRIDGE, Mass. and GOSSELIES, Belgium, May 06, 2021 (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 announced that it will host a conference call and live webcast at 4:30 p.m. ET on Thursday, May 13th, 2021 to report its first quarter 2021 financial results and provide a corporate update.

    Conference Call

    Dial-in numbers: (833) 607-1661 (US/Canada) or (914) 987-7874 (International); Conference ID: 6160559

    Webcast

    A live audio webcast will be accessible from the Events page of the Company's IR website at https://investors.iteostherapeutics.com/news-and-events/events

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, May 06, 2021 (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 announced that it will host a conference call and live webcast at 4:30 p.m. ET on Thursday, May 13th, 2021 to report its first quarter 2021 financial results and provide a corporate update.

    Conference Call

    Dial-in numbers: (833) 607-1661 (US/Canada) or (914) 987-7874 (International); Conference ID: 6160559

    Webcast

    A live audio webcast will be accessible from the Events page of the Company's IR website at https://investors.iteostherapeutics.com/news-and-events/events. A replay will be available on the Company's website approximately two hours after completion of the event and for 30 days following the call

    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 cancer 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 initial 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. An open-label Phase 1/2a clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a next-generation adenosine A2A receptor antagonist tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity in the dose escalation portion of the trial. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contact:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contacts:

    media@iteostherapeutics.com



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  8. CAMBRIDGE, Mass. and GOSSELIES, Belgium, May 03, 2021 (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 announced the appointment of Tony Ho, M.D., and Robert Iannone, M.D., M.S.C.E., to its Board of Directors. They will expand the clinical drug development and strategy expertise of iTeos Board with their track record in leading pharma and biotech companies.

    "We are thrilled to welcome Tony and Robert to our board as we advance our highly innovative immuno-oncology pipeline programs through clinical development," said David Hallal, Chairman of the Board…

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, May 03, 2021 (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 announced the appointment of Tony Ho, M.D., and Robert Iannone, M.D., M.S.C.E., to its Board of Directors. They will expand the clinical drug development and strategy expertise of iTeos Board with their track record in leading pharma and biotech companies.

    "We are thrilled to welcome Tony and Robert to our board as we advance our highly innovative immuno-oncology pipeline programs through clinical development," said David Hallal, Chairman of the Board of iTeos Therapeutics. "Tony and Robert bring extensive experience driving novel oncology product candidates through all phases of clinical development, and their drug development, strategic, operational, and regulatory expertise will be invaluable to iTeos as we urgently advance our EOS-448 and inupadenant programs through development on behalf of patients. We also look forward to drawing on their extensive individual and collective R&D experiences as we continue accelerate and expand our pipeline of next generation oncology therapeutics."

    "iTeos is utilizing innovative new pathways to combat immune suppression and shift towards a more functional immune response, and I have been impressed by the promising data reported to-date, especially in hard-to-treat patients," said Dr. Ho. "I look forward to working with the team to build on this momentum and help bring these much-needed therapies to patients."

    Dr. Iannone added, "I have great respect for the iTeos team's deep expertise in tumor immunology and pragmatic approach to drug development. With two clinical-stage programs now underway, I am excited to partner with the current board and leadership team at such a pivotal time in their growth and to provide guidance as they advance into late-stage development."

    Dr. Ho, M.D. has nearly 20-years of comprehensive R&D experience in the biotechnology and pharmaceutical industry. He currently serves as Executive Vice President, Research and Development at CRISPR Therapeutics, where he leads R&D efforts across all product phases, including discovery, early and late-stage clinical development and regulation. Prior to joining CRIPSR, Dr. Ho held several roles of increasing seniority at AstraZeneca, most recently serving as the Senior Vice President and Head of Oncology Integration and Innovation. At AstraZeneca, he led the development and commercialization of two key drugs: LYNPARZA, a PARP inhibitor for ovarian cancer, and IMFINZI, a PD-L1 inhibitor and AstraZeneca's first immuno-oncology drug for bladder cancer. Before that, Dr. Ho was the Neurology and Ophthalmology Clinical Section Head at Merck Research Laboratories, Merck & Co., and led multiple development programs, including the approval of Maxalt for pediatric migraine and Zioptan for glaucoma. Previously, he was the Co-Founder and Chief Scientific Officer of Neuronyx, a regenerative medicine company. Dr. Ho also currently serves on the Board of Directors of Engrail Therapeutics and is an adjunct Associate Professor at both the University of Pennsylvania and Johns Hopkins University. He earned his M.D. from the Johns Hopkins University School of Medicine and his B.S. in Electrical Engineering at the University of California, Los Angeles.

    Dr. Iannone, M.D., M.S.C.E., brings more than 16 years of experience in clinical drug development. He currently serves as Executive Vice President, Research and Development & Chief Medical Officer at Jazz Pharmaceuticals, where he oversees product development, clinical operations and regulatory affairs. Before that, Dr. Iannone was the Head of Research and Development and Chief Medical Officer of Immunomedics and held roles of increasing at AstraZeneca, where he most recently served as the Senior Vice President and Head of Immuno-oncology, Global Medicines Development and the Global Products Vice President. Previously, Dr. Iannone spent several years in management at Merck, culminating in his role as Executive Director and Section Head of Oncology Clinical Development. Earlier, he worked as an Assistant Professor of Pediatrics at the University of Pennsylvania School of Medicine. He earned his M.D. from Yale University and his B.S. from The Catholic University of America, and completed his pediatric residency, chief residency and pediatric hematology-oncology fellowship at the Johns Hopkins Hospital. Dr. Iannone also currently serves on the board of directors of Jounce Therapeutics.

    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 cancer 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 initial 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. An open-label Phase 1/2a clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a next-generation adenosine A2A receptor antagonist tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity in the dose escalation portion of the trial. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    Forward-Looking Statement 

    This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding the Company's future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting clinical data, projections regarding our long-term growth, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our clinical programs, as well as other statements containing words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions that can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from pre-clinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; whether the Company will receive regulatory approvals to conduct trials or to market products; whether the Company's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on the Company's business, operations, strategy, goals and anticipated timelines, the Company's ongoing and planned pre-clinical activities, the Company's ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, the Company's timelines for regulatory submissions and the Company's financial position; and other risks concerning the Company's programs and operations set forth under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed on March 24, 2021, as updated by its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither the Company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    For further information, please contact:

    Investor Contacts:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contacts:

    media@iteostherapeutics.com

     



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    • Initial data from the Phase 1 dose escalation part of the Phase 1/2a trial in adult patients with advanced solid tumors indicated EOS-448 was generally well tolerated with no dose-limiting toxicities observed

    • EOS-448 showed preliminary signs of clinical activity as a monotherapy, including a partial response in one pembrolizumab-resistant melanoma patient, and stable disease in multiple patients

    • EOS-448 reduced TIGIT+ suppressive T regulatory cells and CD8 T cells considered to be exhausted at all tested doses, indicating engagement of FcγR, an essential component in many immune system effector functions

    • Company to advance EOS-448 into combination trials with pembrolizumab and other novel agents in both checkpoint-naïve and resistant patients
    • Initial data from the Phase 1 dose escalation part of the Phase 1/2a trial in adult patients with advanced solid tumors indicated EOS-448 was generally well tolerated with no dose-limiting toxicities observed



    • EOS-448 showed preliminary signs of clinical activity as a monotherapy, including a partial response in one pembrolizumab-resistant melanoma patient, and stable disease in multiple patients



    • EOS-448 reduced TIGIT+ suppressive T regulatory cells and CD8 T cells considered to be exhausted at all tested doses, indicating engagement of FcγR, an essential component in many immune system effector functions



    • Company to advance EOS-448 into combination trials with pembrolizumab and other novel agents in both checkpoint-naïve and resistant patients



    • Company to host conference call on Monday, April 12th at 8:00 a.m. EDT to discuss results

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, April 10, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (NASDAQ:ITOS), clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, today announced a presentation featuring preliminary clinical data from 22 adult patients in the ongoing Phase 1/2a trial of its anti-TIGIT antibody, EOS-448, at the American Association of Cancer Research (AACR) Annual Meeting 2021, taking place virtually April 10-15. The presentation highlights initial findings from the completed dose escalation monotherapy portion of the trial, indicating a favorable tolerability profile and early signs of clinical activity in advanced cancers.

    "We are pleased to share these data showing promising preliminary signs of clinical activity and a favorable tolerability profile with our anti-TIGIT antibody, EOS-448, in patients with advanced cancers," said Joanne Jenkins Lager, M.D., chief medical officer of iTeos Therapeutics. "The results support our excitement around TIGIT as a therapeutic target capable of harnessing the immune system to treat patients with advanced, difficult to treat cancers. We believe the depletion of TIGIT+ suppressive and exhausted cells shown at even the lowest tested dose provides evidence of engagement of the FcγR, and therefore the potential of EOS-448 to activate multiple immune mechanisms. Based on these encouraging results, we are enrolling a total of 40 patients in this study to evaluate the effects of EOS-448 within the tumor. We are advancing EOS-448 into the next stage of clinical development as both a monotherapy and in combination for the treatment of multiple indications, with the goal of improving outcomes for people with advanced cancers."

    Summary of the Data Presented

    The objective of the dose escalation portion of the ongoing EOS-448 trial, presented at AACR, is to evaluate primary objectives of safety and tolerability, and secondary objectives of pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS-448 as a monotherapy in patients with advanced solid tumor cancers. As of the data cut-off (December 31, 2020), the trial had enrolled 22 advanced cancer patients with solid tumors for whom no standard treatment was available. The patients received EOS-448 intravenously (IV) once every two weeks (Q2W) or once every four weeks (Q4W) according to their dose and schedule allocation. Doses of 20, 70, 200, 700 mg Q2W and 1400 mg Q4W were evaluated. Since the data cut-off for the AACR poster, as of March 9, 2021, an additional 11 patients have received single agent EOS-448. In addition to the five dose levels which were described at AACR, patients have also received doses of 400mg Q4w and 700mg Q4w.



    EOS-448 was generally well-tolerated at all tested doses in patients with advanced cancer. Preliminary evidence of clinical activity as a monotherapy, including a confirmed partial response in one pembrolizumab-refractory melanoma patient and disease stabilization in nine patients, was also observed. The most common treatment related adverse events were itching, infusion-related reactions, fatigue, rash and fever, and one treatment related serious adverse event, a grade 2 systemic inflammatory response, was observed. As of March 9, 2020, two additional treatment-related serious events have been reported: Grade 2 Systemic Inflammatory Response and Grade 3 infusion-related reaction.

    PK assessments indicated a linear and dose-proportional response and PD assessments showed complete target engagement. Biomarker analyses showed evidence of FcγR engagement, as demonstrated by a reduction in suppressive immune cells and immune cells considered to be exhausted in the blood, including TIGIT+ regulatory T cells (Tregs) and TIGIT+ CD8 T cells, with only a slight reduction in the total CD8+ T cell count. A shift towards a more functional immune response was observed, with a two-fold increase in the ratio of CD8+ T cells to Treg and a four-fold increase in the ratio of CD8+ TIGIT- T cells to CD8+ TIGIT+ T cells.

    "I am highly encouraged by these initial results from the EOS-448 trial, particularly the clinically meaningful response to treatment in the pembrolizumab-refractory melanoma patient," said Mario Sznol, M.D., professor of medicine and leader, Melanoma/RCC Disease-Associated Research Team, at Yale University. "The treatment of patients who develop resistance to checkpoint inhibitors is challenging in a number of tumor types, and these data give us hope that EOS-448 could provide benefit in adult solid tumor patients who don't respond to or who progress on current checkpoint inhibitors." 

    The e-poster and abstract can be accessed on the AACR conference website. The abstract and presentation details are as follows:

    Title: Preliminary data from Phase I first-in-human study of EOS884448, a novel potent anti-TIGIT antibody, monotherapy shows favorable tolerability profile and early signs of clinical activity in immune-resistant advanced cancer

    Session: Phase I Clinical Trials

    Poster #: CT118

    Authors: Tom Van den Mooter, et al.

    The Company will host a conference call and webcast to provide an overview of the data on Monday, April 12 at 8:00 a.m. EDT. Details are as follows:

    Participant Dial-In: (833) 607-1661

    International Dial-In: (914) 987-7874

    Conference ID: 2888301

    Webcast: https://edge.media-server.com/mmc/p/ke2wtf4w

    The abstract was posted online at 12:01 a.m. EDT on Friday, April 9 and the e-poster launched at 8:30 a.m. EDT on Saturday, April 10 on the AACR conference website.

    EOS-448 Further Clinical Development Plans

    Based on these preliminary results, the Company plans to advance EOS-448 using combination trials in both checkpoint-naïve and resistant patients. These Phase 1b trials will assess the safety of EOS-448 in combination with pembrolizumab and in combination with iTeos novel agent inupadenant in patients with solid tumors, and as a monotherapy and in combination with an Immunomodulatory Drug (IMiD) in patients with multiple myeloma. Subsequent disease-specific Phase 2a trials are planned in patients with non-small cell lung cancer, head and neck cancer, melanoma, and myeloma. The Company is also planning for later-stage trials of EOS-448, including in combination with pembrolizumab.

    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 cancer 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 initial 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. An open-label Phase 1/2a clinical trial of EOS-448 is ongoing in adult cancer patients with advanced solid tumors with preliminary data indicating clinical activity as a monotherapy and a favorable tolerability profile. The Company is also advancing inupadenant, a next-generation adenosine A2A receptor antagonist tailored to overcome cancer immunosuppression. iTeos is conducting an open-label multi-arm Phase 1/2a clinical trial of inupadenant in adult cancer patients with advanced solid tumors. Preliminary results indicate encouraging single-agent activity in the dose escalation portion of the trial. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.



    Forward-Looking Statement

    This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding the Company's future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting clinical data, projections regarding our long-term growth, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our clinical programs, as well as other statements containing words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions that can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from pre-clinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; whether the Company will receive regulatory approvals to conduct trials or to market products; whether the Company's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on the Company's business, operations, strategy, goals and anticipated timelines, the Company's ongoing and planned pre-clinical activities, the Company's ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, the Company's timelines for regulatory submissions and the Company's financial position; and other risks concerning the Company's programs and operations set forth under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed on March 24, 2021, as updated by its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither the Company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    For further information, please contact:

    Investor Contacts:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contacts:

    media@iteostherapeutics.com



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  9. – Initial data from Phase 1/2a trial of EOS-448 to be presented at American Association for Cancer Research Annual Meeting. Company to hold conference call at 8:00 am on April 12th to discuss results –

    – Updated, single-agent data of inupadenant (EOS-850) from Phase 1/2a trial and initial pembrolizumab combination data are expected to be reported later in 2021 –

    – Strong cash balance of $336.3M allows company to rapidly advance clinical programs and continue to invest in discovery efforts to expand pipeline –

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, March 24, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (NASDAQ:ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly…

    – Initial data from Phase 1/2a trial of EOS-448 to be presented at American Association for Cancer Research Annual Meeting. Company to hold conference call at 8:00 am on April 12th to discuss results –

    – Updated, single-agent data of inupadenant (EOS-850) from Phase 1/2a trial and initial pembrolizumab combination data are expected to be reported later in 2021 –

    – Strong cash balance of $336.3M allows company to rapidly advance clinical programs and continue to invest in discovery efforts to expand pipeline –

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, March 24, 2021 (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 reported financial results for the fourth quarter and full year ended December 31, 2020 and provided recent business highlights.

    "In 2020, we laid a strong foundation, growing our leadership team and completing an IPO in July that solidified our cash position to support our clinical trials and operations into the second half of 2023. We are making strong progress advancing the Phase 1/2a trials for our two lead clinical candidates, inupadenant, our adenosine A2A receptor antagonist, and EOS-448, our anti-TIGIT antibody. We look forward to reporting initial data for our TIGIT program at the upcoming AACR Annual Meeting in April, followed by updated data from our expansion cohorts for inupadenant later this year," said Michel Detheux, PhD, president and chief executive officer of iTeos. "As we approach multiple near-term clinical milestones, we also continue to leverage our deep knowledge of the tumor microenvironment to perform rigorous preclinical evaluations to grow our pipeline of highly differentiated immuno-oncology therapeutics and expect to nominate an additional product candidate by year-end."

    Program Highlights

    Inupadenant (EOS-850): Designed as a highly selective small molecule insurmountable antagonist of the adenosine A2A receptor, or A2AR, to inhibit the adenosine pathway which is a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. Currently in a multi-arm Phase 1/2a clinical trial in adult patients with advanced solid tumors.

    • The company is currently enrolling patients in three distinct cohorts in its Phase 1/2a study as both a monotherapy and in combination. The initial cohort is evaluating inupadenant as a monotherapy in a basket of cancers, and the second cohort is evaluating the safety of inupadenant in combination with pembrolizumab in patients with solid tumors. The final cohort is evaluating inupadenant in combination with chemotherapy in patients with triple-negative breast cancer.
    • Updated single-agent data, including results from tumor biopsy analyses, and initial pembrolizumab combination data are expected to be reported later in 2021.

    EOS-448: Antagonistic antibody specifically designed to target TIGIT (T-cell immunoreceptor with Ig and ITIM domains), a checkpoint with multiple mechanisms leading to immunosuppression. EOS-448 was also selected to engage the Fc gamma receptor, or FcγR, and enhance the anti-tumor response through a multifaceted immune modulatory mechanism. These mechanisms include the activation of macrophages and dendritic cells and the promotion of antibody-dependent cellular cytotoxicity, or ADCC, leading to the selective depletion of cells which express high levels of TIGIT including immunosuppressive regulatory T cells and exhausted T cells. Currently in a Phase 1/2a clinical trial in multiple advanced solid tumors.

    • Enrollment in the dose escalation portion of the study has now been completed. Following the determination of the recommended Phase 2 dose, the company expects to begin trials in mid-2021 to evaluate EOS-448 in combination with pembrolizumab, an anti-PD-1 antibody, in combination with inupadenant, and in other combinations in specific tumor types.
    • The company will present initial clinical and safety data as part of a late-breaking e-poster at the first session of the upcoming American Association for Cancer Research (AACR) Annual Meeting being held virtually April 10-15, 2021. The poster will go live on Saturday, April 10th at 8:30 a.m. ET, and company management will hold a call on Monday, April 12th at 8:00 a.m. ET to discuss the results.
      • Abstract Title: CT118 - Preliminary data from Phase I first-in-human study of EOS884448, a novel potent anti-TIGIT antibody, monotherapy shows favorable tolerability profile and early signs of clinical activity in immune-resistant advanced cancers.
      • Abstract Number: IO-002-Abst-001

    Preclinical programs: The company continues to progress research programs focused on additional targets that complement the mechanism of action of A2AR and TIGIT programs or address additional pathways of immunosuppression. The company is optimizing its screening and selection process to identify potential product candidates and expects to nominate an additional product candidate for Investigational New Drug-enabling studies before the end of 2021.

    Upcoming Events

    • American Association for Cancer Research (AACR) Annual Meeting, April 10-15, 2021
    • Kempen Life Sciences Conference - European Immuno and Targeted Oncology, April 21, 2021
    • Jefferies Healthcare Conference, June 1-4, 2021

    Fourth Quarter and Full Year 2020 Financial Results

    • Cash Position: The Company's cash and cash equivalent position was $336.3 million as of December 31, 2020, as compared to $19.9 million as of December 31, 2019. Cash balance provides runway into second half of 2023.
    • Research and Development (R&D) Expenses: R&D expenses were $9.2 million for the quarter and $29.9 million for the full year ended December 31, 2020, as compared to $6.0 million for the fourth quarter and $19.2 million for the full year of 2019. The increase was primarily due to an increase in activities related to clinical trials for inupadenant and EOS-448.
    • General and Administrative (G&A) Expenses: G&A expenses were $5.7 million for the quarter and $15.3 million for the full year ended December 31, 2020, as compared to $2.3 million for the fourth quarter and $8.8 million for the full year of 2019. The increase in both periods was primarily due to increased headcount and professional fees associated with becoming a publicly traded company.
    • Net Loss: Net loss attributable to common shareholders was $14.9 million, or a net loss of $0.43 per basic and diluted share, for the quarter ended December 31, 2020, as compared to $6.6 million, or a net loss of $23.30 per basic and diluted share, for the fourth quarter of 2019. Net loss was $43.4 million, or a net loss of $2.88 per basic and diluted share, for the year ended December 31, 2020, as compared to $26.5 million, or a net loss of $130.85 per basic and diluted share, for the full year of 2019.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, inupadenant, is designed as a highly selective small molecule insurmountable antagonist of the adenosine A2A receptor, in the adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. Inupadenant is being investigated in an open-label multi-arm Phase 1/2a clinical trial in adult cancer patients with advanced solid tumors and encouraging preliminary single-agent activity was observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, a checkpoint that has a role in both inhibitory and stimulatory pathways in the immune system. EOS-448 was also selected to engage the Fc gamma receptor, or FcγR, and enhance the anti-tumor response through a multifaceted immune modulatory mechanism. These mechanisms include the activation of macrophages and dendritic cells, and promotion of antibody-dependent cellular cytotoxicity, or ADCC, leading to the selective depletion of cells which express high levels of TIGIT including immunosuppressive regulatory T cells and exhausted T cells. An open-label Phase 1/2a clinical trial of EOS-448 was initiated in adult cancer patients with advanced solid tumors. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    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, including express or implied statements regarding iTeos' future expectations, plans and prospects, which are based on currently available information. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, future financial condition, future operations, prospects, plans, objectives of management and expected growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as ‘‘aim,'' ‘‘anticipate,'' ‘‘assume,'' ‘‘believe,'' ‘‘contemplate,'' ‘‘continue,'' ‘‘could,'' ‘‘design,'' ‘‘due,'' ‘‘estimate,'' ‘‘expect,'' ‘‘goal,'' ‘‘intend,'' ‘‘may,'' ‘‘objective,'' ‘‘plan,'' ‘‘predict,'' ‘‘positioned,'' ‘‘potential,'' ‘‘seek,'' ‘‘should,'' ‘‘target,'' ‘‘will,'' ‘‘would'' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about the initiation, timing, progress and results of our current and future clinical trials and current and future preclinical studies of our product candidates, including our clinical trials of inupadenant, our clinical trials of EOS-448 and of our research and development programs; uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical trials; the expected timing of announcing additional product candidates; the enrollment of our ongoing clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future clinical trials; our ability to successfully establish or maintain collaborations or strategic relationships for our product candidates; the expected timing for submissions for regulatory approval or review by governmental authorities; the composition of our board of directors; our financial performance; whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on our business, operations, strategies and anticipated timelines, including mitigation efforts and economic effects, including but not limited to our preclinical studies and future clinical trials; and our plans to develop and commercialize our current product candidates and any future product candidates and the implementation of our business model and strategic plans for our business, current product candidates and any future product candidates, and other risks concerning iTeos' programs and operations that are described in additional detail in our Annual Report on Form 10-K and our other filings made with the Securities and Exchange Commission from time to time. Although our forward-looking statements reflect the good faith judgment of management, these statements are based solely on facts and circumstances currently known to iTeos. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. iTeos undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, the occurrence of certain events or otherwise.

    For further information, please contact:

    Investor Contacts:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contacts:

    Chelsey Nostro

    W20 Group

    CNostro@w2ogroup.com

    iTeos and iTeos logo are trademarks of iTeos Therapeutics Inc.



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  10. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Feb. 23, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will present at the upcoming virtual investor conferences in March:

    Cowen 41st Annual Health Care Conference
    Date: Tuesday, March 2, 2021
    Time: 11:50 a.m. ET

    H.C. Wainwright Global Life Sciences Conference
    Date: Tuesday, March 9, 2021
    Time: 7:00 a.m. ET

    A live webcast of each presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Feb. 23, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will present at the upcoming virtual investor conferences in March:

    Cowen 41st Annual Health Care Conference

    Date: Tuesday, March 2, 2021

    Time: 11:50 a.m. ET

    H.C. Wainwright Global Life Sciences Conference

    Date: Tuesday, March 9, 2021

    Time: 7:00 a.m. ET

    A live webcast of each presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, inupadenant, is designed as a highly selective small molecule antagonist of the adenosine A2A receptor, in the adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. Inupadenant is being investigated in an open-label multi-arm Phase 1/2a clinical trial in adult cancer patients with advanced solid tumors and encouraging preliminary single-agent activity was observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, a checkpoint that has a role in both inhibitory and stimulatory pathways in the immune system. EOS-448 was also selected to engage the Fc gamma receptor and to promote antibody-dependent cellular cytotoxicity activity. An open-label Phase 1/2a clinical trial of EOS-448 was initiated in adult cancer patients with advanced solid tumors. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contact:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700

    iteos@consilium-comms.com



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  11. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Feb. 17, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will host a fireside chat at the virtual 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24, 2021 at 3:00 p.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    About

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Feb. 17, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will host a fireside chat at the virtual 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24, 2021 at 3:00 p.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, inupadenant, is designed as a highly selective small molecule antagonist of the adenosine A2A receptor, in the adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. Inupadenant is being investigated in an open-label multi-arm Phase 1/2a clinical trial in adult cancer patients with advanced solid tumors and encouraging preliminary single-agent activity was observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, a checkpoint that has a role in both inhibitory and stimulatory pathways in the immune system. EOS-448 was also selected to engage the Fc gamma receptor and to promote antibody-dependent cellular cytotoxicity activity. An open-label Phase 1/2a clinical trial of EOS-448 was initiated in adult cancer patients with advanced solid tumors. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contact:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com 

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700

    iteos@consilium-comms.com



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  12. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Jan. 05, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will present a company overview at the 39th Annual J.P. Morgan Conference, being held virtually on Tuesday, January 12, 2021 at 9:10 a.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    About

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Jan. 05, 2021 (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 announced that Michel Detheux, PhD, President and Chief Executive Officer, will present a company overview at the 39th Annual J.P. Morgan Conference, being held virtually on Tuesday, January 12, 2021 at 9:10 a.m. ET.

    A live webcast of the presentation will be available on the Investors section of the company's website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A2a receptor, in the adenosine triphosphate adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label Phase 1/2a clinical trial in adult patients with advanced solid tumors and encouraging preliminary single-agent activity were observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, or T-cell immunoreceptor with Ig and ITIM domains, a checkpoint that has a role in both inhibitory and stimulatory pathways in the immune system. EOS-448 was also designed to engage the Fc gamma receptor, or FcγR, to promote antibody-dependent cellular cytotoxicity, or ADCC, activity, including the elimination of tumor-infiltrating regulatory T cells, or Tregs. An open-label Phase 1/2a clinical trial of EOS-448 was recently initiated in adult patients with advanced solid tumors. Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contact:

    Ryan Baker

    iTeos Therapeutics, Inc.

    Ryan.Baker@iteostherapeutics.com

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700

    iteos@consilium-comms.com



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  13. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 23, 2020 (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 announced that management will present at the Piper Sandler 32nd Annual Healthcare Conference, taking place December 1 – 3, 2020.

    The fireside chat is now available for registered attendees to view on-demand through the duration of the event using the following link: https://pipersandler.zoom.us/rec/play/BpVKaQQBgtgH_2E-1VrjzcTFrYnR5C2p9oDagY_yXSEg1Uq7jJT7TazUadfvj3EGObsP6cX3aIuc7Y7M.VPHMhFu05uq-jZtF

    A recording of the presentation is also available…

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 23, 2020 (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 announced that management will present at the Piper Sandler 32nd Annual Healthcare Conference, taking place December 1 – 3, 2020.

    The fireside chat is now available for registered attendees to view on-demand through the duration of the event using the following link: https://pipersandler.zoom.us/rec/play/BpVKaQQBgtgH_2E-1VrjzcTFrYnR5C2p9oDagY_yXSEg1Uq7jJT7TazUadfvj3EGObsP6cX3aIuc7Y7M.VPHMhFu05uq-jZtF

    A recording of the presentation is also available on the News and Events section of iTeos' investor website at https://investors.iteostherapeutics.com/ and will remain active for 90 days.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A2a receptor, in the adenosine triphosphate adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label Phase 1/2a clinical trial in adult patients with advanced solid tumors and encouraging preliminary single-agent activity were observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, or T-cell immunoreceptor with Ig and ITIM domains, a checkpoint that has a role in both inhibitory and stimulatory pathways in the immune system. EOS-448 was also designed to engage the Fc gamma receptor, or FcγR, to promote antibody-dependent cellular cytotoxicity, or ADCC, activity, including the elimination of tumor-infiltrating regulatory T cells, or Tregs. An open-label Phase 1/2a clinical trial of EOS-448 was recently initiated in adult patients with advanced solid tumors. Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contacts:

    Sarah McCabe, Zofia Mita

    Stern Investor Relations, Inc.

    + 1 212 362 1200

    iTeos@sternir.com

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700

    iteos@consilium-comms.com

     



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  14. - Patient enrollment in Phase 1/2 studies of EOS-850 A2AR antagonist and EOS-448 FCγR-enabled anti-TIGIT antibody continues with initial data expected in 1H21 - 

    - Strong cash position to support ongoing clinical development and operations into 2023 -

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 12, 2020 (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 reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights.

    "We are focused on advancing our two lead candidates, EOS-850, our adenosine A2A receptor…

    - Patient enrollment in Phase 1/2 studies of EOS-850 A2AR antagonist and EOS-448 FCγR-enabled anti-TIGIT antibody continues with initial data expected in 1H21 - 

    - Strong cash position to support ongoing clinical development and operations into 2023 -

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 12, 2020 (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 reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights.

    "We are focused on advancing our two lead candidates, EOS-850, our adenosine A2A receptor antagonist, and EOS-448, our TIGIT antagonist, both now in Phase 1/2a clinical development, toward initial data readouts in the first half of 2021," said Michel Detheux, PhD, President and Chief Executive Officer of iTeos. "While we have faced some challenges due to the unpredictable nature of the evolving COVID-19 pandemic, our data readout timelines remain on track and we are building our team and competencies to support our ongoing clinical trials. In addition to our clinical efforts, we also continue to perform rigorous preclinical evaluations to identify potential novel product candidates that will contribute to the further growth of our pipeline. As we continue to advance our efforts to discover and develop highly differentiated immune-oncology therapeutics, we now expect to nominate a new drug product candidate before the end of 2021."

    Pipeline Highlights

    EOS-850: Designed as a highly selective small molecule antagonist of the adenosine A2A receptor, or A2AR, to inhibit the adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors.

    • Enrollment continues in Phase 1/2a clinical trial in adult patients with advanced solid tumors: The multi-arm Phase 1/2a clinical trial of EOS-850 trial in adult patients with advanced solid tumors is ongoing. In addition to the single-agent cohort, dosing has also commenced in the second cohort evaluating EOS-850 in combination with pembrolizumab. The COVID-19 pandemic has resulted in the Company experiencing enrollment delays for its third cohort evaluating EOS-850 in combination with chemotherapy. The Company is now opening additional sites in the U.S., France, Spain and South Korea to support continued enrollment and expects to dose the first patient in the chemotherapy cohort by the end of 2020. The Company remains on-track to report initial single-agent and combination data in the first half of 2021.

    EOS-448: Antagonistic antibody specifically designed to target TIGIT (T-cell immunoreceptor with Ig and ITIM domains), a checkpoint with multiple mechanisms leading to immunosuppression. EOS-448 was also selected to engage the Fc gamma receptor, or FcγR, to promote antibody-dependent cellular cytotoxicity, or ADCC, activity.

    • Patient enrollment continues in Phase 1/2a clinical trial: The dose escalation portion of the Phase 1/2a clinical trial of EOS-448 in multiple advanced solid tumors is ongoing. Initial safety and efficacy data are expected to be reported in the first half of 2021. Following the completion of the dose escalation and determination of the recommended Phase 2 dose, we plan to evaluate EOS-448 in combination with an anti-PD-1 antibody and other standard of care therapies or EOS-850 in specific tumor types.

    Preclinical programs: The Company continues to progress research programs focused on additional targets that complement its A2AR and TIGIT programs. The Company is optimizing its screening and selection process to identify potential product candidates and expects to nominate an additional product candidate for Investigational New Drug, or IND, enabling studies before the end of 2021.

    Corporate Updates

    • Publication in Molecular Cancer Therapeutics: An article on the multiple mechanisms of action of anti-TIGIT antagonistic antibodies highlighting our work in the field and the properties of EOS-448 was accepted for publication in Molecular Cancer Therapeutics.
    • Completed Initial Public Offering (IPO) raising $229.7 million in gross proceeds: As previously announced in July 2020, the Company completed its initial public offering of 10,586,316 shares of common stock at a public offering price of $19.00 per share. In August 2020, the underwriters exercised their option to purchase an additional 1,505,359 shares.

    Third Quarter 2020 Financial Results

    • Cash Position: The Company's cash and cash equivalent position was $340.0 million as of September 30, 2020, as compared to $19.9 million as of December 31, 2019.
    • Research and Development (R&D) Expenses: R&D expenses were $8.7 million for the quarter ended September 30, 2020, as compared to $5.0 million for the third quarter of 2019. The increase was primarily due to an increase in activities related to clinical trials for EOS-850 and EOS-448.
    • General and Administrative (G&A) Expenses: G&A expenses were $4.8 million for the quarter ended September 30, 2020, as compared to $2.7 million for the third quarter of 2019. The increase was primarily due to an increase in payroll and related costs in the third quarter of 2020.
    • Net Loss: Net loss attributable to common shareholders was $11.7 million, or a net loss of $0.48 per basic and diluted share, for the quarter ended September 30, 2020, as compared to $8.0 million, or a net loss of $43.03 per basic and diluted share, for the third quarter of 2019.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A2AR, in the adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label multi-arm Phase 1/2a clinical trial in adult cancer patients with advanced solid tumors and encouraging preliminary single-agent activity was observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, a checkpoint with multiple mechanisms leading to immunosuppression. EOS-448 was also selected to engage FcγR, to promote ADCC activity. An open-label Phase 1/2a clinical trial of EOS-448 was initiated in adult cancer patients with advanced solid tumors. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    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, including express or implied statements regarding iTeos' future expectations, plans and prospects, which are based on currently available information. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, future financial condition, future operations, prospects, plans, objectives of management and expected growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as ‘‘aim,'' ‘‘anticipate,'' ‘‘assume,'' ‘‘believe,'' ‘‘contemplate,'' ‘‘continue,'' ‘‘could,'' ‘‘design,'' ‘‘due,'' ‘‘estimate,'' ‘‘expect,'' ‘‘goal,'' ‘‘intend,'' ‘‘may,'' ‘‘objective,'' ‘‘plan,'' ‘‘predict,'' ‘‘positioned,'' ‘‘potential,'' ‘‘seek,'' ‘‘should,'' ‘‘target,'' ‘‘will,'' ‘‘would'' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about the initiation, timing, progress and results of our current and future clinical trials and current and future preclinical studies of our product candidates, including our clinical trials of EOS-850, our clinical trials of EOS-448 and of our research and development programs; uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical trials; the enrollment of our ongoing clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future clinical trials; our ability to successfully establish or maintain collaborations or strategic relationships for our product candidates; the expected timing for submissions for regulatory approval or review by governmental authorities; the composition of our board of directors; our financial performance; whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on our business, operations, strategies and anticipated timelines, including mitigation efforts and economic effects, including but not limited to our preclinical studies and future clinical trials; and our plans to develop and commercialize our current product candidates and any future product candidates and the implementation of our business model and strategic plans for our business, current product candidates and any future product candidates, and other risks concerning iTeos' programs and operations that are described in additional detail in our Quarterly Report on Form 10-Q and our other filings made with the Securities and Exchange Commission from time to time. Although our forward-looking statements reflect the good faith judgment of management, these statements are based solely on facts and circumstances currently known to iTeos. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. iTeos undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, the occurrence of certain events or otherwise.

    For further information, please contact:

    Investor Contacts:

    Sarah McCabe, Zofia Mita

    Stern Investor Relations, Inc.

    + 1 212 362 1200

    iTeos@sternir.com

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700

    iteos@consilium-comms.com

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  15. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 12, 2020 (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 announced the appointment of Matthew Roden, Ph.D., to its Board of Directors. Dr. Roden joins the Board as a Partner of MPM Capital and will replace Ansbert Gadicke, M.D.

    "Matt will be a tremendous addition to our board due to his vast leadership experience spanning both the pharmaceutical and financial industries," said David Hallal, chairman of the iTeos Board of Directors. "He will offer a holistic corporate development perspective and strategic support…

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 12, 2020 (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 announced the appointment of Matthew Roden, Ph.D., to its Board of Directors. Dr. Roden joins the Board as a Partner of MPM Capital and will replace Ansbert Gadicke, M.D.

    "Matt will be a tremendous addition to our board due to his vast leadership experience spanning both the pharmaceutical and financial industries," said David Hallal, chairman of the iTeos Board of Directors. "He will offer a holistic corporate development perspective and strategic support that will allow us to continue our evolution as both a clinical-stage, and newly public, company. In particular, his deep experience in global transactions will add dimension to our board and complement the innovation and scientific rigor displayed by our leadership team to date."

    "Ansbert played a key role in building iTeos from its early development through its clinical and corporate growth. On behalf of the members of the management team and my fellow board members, I would like to thank him for his significant contributions to our success," said Michel Detheux, Ph.D., Co-Founder, President and Chief Executive Officer of iTeos. "I look forward to working together with Matt to continue delivering on our common mission to develop life-transforming cancer therapies to patients in need."

    "I am excited to join the iTeos board," said Dr. Roden "I have been very impressed with iTeos' progress and position it has established as a leader in both identifying and developing next-generation immuno-oncology targets. The leadership team's expertise in tumor immunology has put iTeos at the forefront of the next wave of potential best-in-class cancer therapies, and I look forward to working together to advance its mission."

    Dr. Roden is an Executive Partner at MPM Capital. Prior to joining MPM Capital, he was Senior Vice President and Head of Enterprise Strategy at Bristol Myers Squibb. Earlier, he served as Head of Strategic Corporate Development and Head of Global BD Assessment, leading teams on over 100 business development transactions that are cumulatively valued at over $125 billion. Before joining Bristol Myers Squibb, Dr. Roden led equity research on the biotechnology sector at UBS Investment Bank. Earlier, he was a Senior Equity Analyst covering biotechnology at J.P. Morgan, and Bank of America Merrill Lynch, and was an Associate at Credit Suisse First Boston. Dr. Roden earned his Ph.D. at the Albert Einstein College of Medicine, focusing on the structural biology of immune-relevant molecules, and earlier was a pre-doctoral clinical research fellow in immuno-oncology at the National Cancer Institute in Bethesda, Maryland. Dr. Roden holds a M.S. degree from Georgetown University and a B.S. from George Mason University.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A2AR, in the adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label multi-arm Phase 1/2a clinical trial in adult cancer patients with advanced solid tumors and encouraging preliminary single-agent activity was observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, a checkpoint with multiple mechanisms leading to immunosuppression. EOS-448 was also selected to engage FcγR, to promote ADCC activity. An open-label Phase 1/2a clinical trial of EOS-448 was initiated in adult cancer patients with advanced solid tumors. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700

    iteos@consilium-comms.com

    Investor Contacts:

    Sarah McCabe, Zofia Mita

    Stern Investor Relations, Inc.

    + 1 212 362 1200

    iTeos@sternir.com

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  16. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 05, 2020 (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 announced that management will participate in the upcoming virtual investor conferences in November:

    Presentation:

    Credit Suisse 29th Annual Virtual Healthcare Conference
    Date: Thursday, November 12, 2020
    Time: 12:30 p.m. ET

    1x1 Investor Meetings:

    Jefferies Global Healthcare Conference
    Date: Tuesday, November 17 – Thursday, November 19, 2020

    SVB Leerink Oncology 1x1 Day
    Date: Thursday, November 19, 2020

    A live audio webcast of the Credit Suisse presentation…

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 05, 2020 (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 announced that management will participate in the upcoming virtual investor conferences in November:

    Presentation:

    Credit Suisse 29th Annual Virtual Healthcare Conference

    Date: Thursday, November 12, 2020

    Time: 12:30 p.m. ET

    1x1 Investor Meetings:

    Jefferies Global Healthcare Conference

    Date: Tuesday, November 17 – Thursday, November 19, 2020

    SVB Leerink Oncology 1x1 Day

    Date: Thursday, November 19, 2020

    A live audio webcast of the Credit Suisse presentation will be available on the News and Events section of iTeos' investor website at https://investors.iteostherapeutics.com/. A replay of the webcast will be available for 30 days following the presentation.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A2A receptor, in the adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label multi-arm Phase 1/2a clinical trial in adult cancer patients with advanced solid tumors and encouraging preliminary single-agent activity was observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, or T-cell immunoreceptor with Ig and ITIM domains, a checkpoint that has a role in both inhibitory and stimulatory pathways in the immune system. EOS-448 was also selected to engage the Fc gamma receptor, or FcγR, and to promote antibody-dependent cellular cytotoxicity, or ADCC, activity. An open-label Phase 1/2a clinical trial of EOS-448 was initiated in adult cancer patients with advanced solid tumors. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Investor Contacts:

    Sarah McCabe, Zofia Mita

    Stern Investor Relations, Inc.

    + 1 212 362 1200

    iTeos@sternir.com

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700

    iteos@consilium-comms.com 

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  17. CAMBRIDGE, Mass. and GOSSELIES, Belgium, Sept. 08, 2020 (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 announced that management will participate in two upcoming virtual investor conferences in September.

    Citi's 15th Annual BioPharma Virtual Conference
    Date: Wednesday, September 9 – Thursday, September 10, 2020

    H.C. Wainwright 22nd Annual Global Investment Conference
    Date: Tuesday, September 15, 2020
    Presentation Time: 5:00 p.m. ET

    A live audio webcast of the H.C. Wainwright presentation will be available on the News and Events section of iTeos' investor…

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Sept. 08, 2020 (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 announced that management will participate in two upcoming virtual investor conferences in September.

    Citi's 15th Annual BioPharma Virtual Conference

    Date: Wednesday, September 9 – Thursday, September 10, 2020

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Tuesday, September 15, 2020

    Presentation Time: 5:00 p.m. ET

    A live audio webcast of the H.C. Wainwright presentation will be available on the News and Events section of iTeos' investor website at https://investors.iteostherapeutics.com/. A replay of the webcast will be available for 30 days following the presentation.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A2a receptor, in the adenosine triphosphate adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label Phase 1/2a clinical trial in adult patients with advanced solid tumors and encouraging preliminary single-agent activity were observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, or T-cell immunoreceptor with Ig and ITIM domains, a checkpoint that has a role in both inhibitory and stimulatory pathways in the immune system. EOS-448 was also designed to engage the Fc gamma receptor, or FcγR, to promote antibody-dependent cellular cytotoxicity, or ADCC, activity, including the elimination of tumor-infiltrating regulatory T cells, or Tregs. An open-label Phase 1/2a clinical trial of EOS-448 was recently initiated in adult patients with advanced solid tumors. Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    For further information, please contact:

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700

    iteos@consilium-comms.com 

    Investor Contacts:

    Sarah McCabe, Zofia Mita

    Stern Investor Relations, Inc.

    + 1 212 362 1200

    iTeos@sternir.com 

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  18. - July 2020 IPO provided $210.6 million in net proceeds and extends cash runway into 2023 -

    - EOS-850 A2AR antagonist and EOS-448 FCgR-enabled anti-TIGIT antibody continue to progress in clinical trials -

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Sept. 01, 2020 (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 reported financial results for the second quarter ended June 30, 2020 and recent business highlights.

    "The completion of our successful IPO in July was a major milestone for iTeos and further supports the advancement of our highly differentiated…

    - July 2020 IPO provided $210.6 million in net proceeds and extends cash runway into 2023 -

    - EOS-850 A2AR antagonist and EOS-448 FCgR-enabled anti-TIGIT antibody continue to progress in clinical trials -

    CAMBRIDGE, Mass. and GOSSELIES, Belgium, Sept. 01, 2020 (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 reported financial results for the second quarter ended June 30, 2020 and recent business highlights.

    "The completion of our successful IPO in July was a major milestone for iTeos and further supports the advancement of our highly differentiated immunotherapy pipeline, including our two lead product candidates, our adenosine A2a receptor antagonist, EOS-850, and TIGIT antagonist, EOS-448," said Michel Detheux, PhD, President and Chief Executive Officer of iTeos. "With trials ongoing for our two lead product candidates, we anticipate that 2021 will be a data-rich year and we hope to continue to leverage our deep understanding of immune pathways and the tumor microenvironment to identify additional novel product candidates that can improve the clinical benefit for patients suffering from cancers."

    Recent Business Highlights

    EOS-850: Designed as a highly selective small molecule antagonist of the adenosine A2a receptor, or A2AR, to inhibit the adenosine triphosphate, or ATP, adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors.

    • Enrollment continues in Phase 1/2a clinical trial in adult patients with advanced solid tumors: The EOS-850 monotherapy trial in adult patients with advanced solid tumors is ongoing and the company expects to report initial data from monotherapy and combination therapy cohorts in the first half of 2021.
    • AACR data presentation showed encouraging safety and efficacy signals in Dose Escalation: The Company presented initial data from the monotherapy, dose escalation portion of the Phase 1/2a clinical trial of EOS-850 in 21 heavily pre-treated cancer patients with advanced solid tumors at the American Association of Cancer Research (AACR) Virtual Annual Meeting in April 2020. The data showed that EOS-850 was reported to be generally well tolerated with no dose-limiting toxicities observed. EOS-850 showed preliminary single-agent clinical benefit in two patients with confirmed partial response and an additional five patients with stable disease.

    EOS-448: Antagonist specifically designed to target T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint that has a role in both inhibitory and stimulatory pathways in the immune system. EOS-448 was also designed to engage the Fc gamma receptor, or FcgR, to promote antibody-dependent cellular cytotoxicity (ADCC) activity, including the elimination of tumor-infiltrating regulatory T cells.

    • Patient enrollment continues in Phase 1/2a clinical trial: The dose escalation portion of the Phase 1/2a clinical trial of EOS-448 was initiated in February 2020. Initial safety and efficacy data are expected to be reported in the first half of 2021. Following dose escalation and determination of the recommended Phase 2 dose, the study design allows for the expansion of patient cohorts to evaluate the anti-tumor activity of EOS-448 in specific tumor types. 
    • AACR preclinical data presentation demonstrating an encouraging preclinical therapeutic index: In June 2020, the company presented data for EOS-448 showing potent antitumor activity and a favorable tolerability profile in preclinical studies at the American Association of Cancer Research II Virtual Annual Meeting.

    Corporate Updates

    • Completed Initial Public Offering (IPO) raising $229.7 million in gross proceeds: In July 2020, iTeos completed its IPO of 10,586,316 shares of common stock at a public offering price of $19.00 per share. In August 2020, the underwriters exercised their option to purchase an additional 1,505,359 shares.
    • Strengthened leadership team with key appointments: In June 2020, iTeos announced the appointments of Matthew Gall as Chief Financial Officer, Dr. Yvonne McGrath as Vice President of Research and Development and Philippe Brantegem as Vice President of Human Resources. Matthew Gall joins iTeos Therapeutics from Sarepta Therapeutics, Inc. where he was the Senior Vice President of Corporate Development and Treasurer. Dr. Yvonne McGrath joins iTeos Therapeutics from Complix N.V. where she served as the Chief Scientific Officer. Philippe Brantegem has delivered human resources support to biopharmaceutical companies such as Merck Sharp & Dohme, Besins Healthcare, Sanofi Pasteur MSD and Korn Ferry for over 20 years. 
    • Added Ann D. Rhoads to Board of Directors: In June 2020, iTeos announced the appointment of Ann D. Rhoads to its Board of Directors. Ms. Rhoads brings over 25 years of corporate and financial expertise in the life sciences and healthcare industry.

    Second Quarter 2020 Financial Results

    • Cash Position: Cash was $136.9 million as of June 30, 2020, as compared to $19.9 million as of December 31, 2019.
    • Research and Development (R&D) Expenses: R&D expenses were $6.1 million for the quarter ended June 30, 2020, as compared to $3.9 million for the second quarter of 2019. The increase was primarily due to an increase in activities related to clinical trials for EOS-850 and EOS-448.
    • General and Administrative (G&A) Expenses: G&A expenses were $2.4 million for the quarter ended June 30, 2020, as compared to $2.1 million for the second quarter of 2019. The increase was primarily due to an increased payroll and related costs, including recruiting fees, due to the hiring of additional executives in the second quarter of 2020.
    • Net Loss: Net loss attributable to common shareholders was $10.3 million, or a net loss of $29.49 per basic and diluted share, for the quarter ended June 30, 2020, as compared to $6.8 million, or a net loss of $36.49 per basic and diluted share, for the second quarter of 2019.

    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 the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A2a receptor, in the adenosine triphosphate adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label Phase 1/2a clinical trial in adult patients with advanced solid tumors and encouraging preliminary single-agent activity were observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, or T-cell immunoreceptor with Ig and ITIM domains, a checkpoint that has a role in both inhibitory and stimulatory pathways in the immune system. EOS-448 was also designed to engage the Fc gamma receptor, or FcγR, to promote antibody-dependent cellular cytotoxicity, or ADCC, activity, including the elimination of tumor-infiltrating regulatory T cells, or Tregs. An open-label Phase 1/2a clinical trial of EOS-448 was recently initiated in adult patients with advanced solid tumors. Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

    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, including express or implied statements regarding iTeos' future expectations, plans and prospects, which are based on currently available information. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, future financial condition, future operations, prospects, plans, objectives of management and expected growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as ‘‘aim,'' ‘‘anticipate,'' ‘‘assume,'' ‘‘believe,'' ‘‘contemplate,'' ‘‘continue,'' ‘‘could,'' ‘‘design,'' ‘‘due,'' ‘‘estimate,'' ‘‘expect,'' ‘‘goal,'' ‘‘intend,'' ‘‘may,'' ‘‘objective,'' ‘‘plan,'' ‘‘predict,'' ‘‘positioned,'' ‘‘potential,'' ‘‘seek,'' ‘‘should,'' ‘‘target,'' ‘‘will,'' ‘‘would'' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about the initiation, timing, progress and results of our current and future clinical trials and current and future preclinical studies of our product candidates, including our clinical trials of EOS-850, our clinical trials of EOS-448 and of our research and development programs; uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future clinical trials; our ability to successfully establish or maintain collaborations or strategic relationships for our product candidates; the expected timing for submissions for regulatory approval or review by governmental authorities; our financial performance; whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on our business, operations, strategies and anticipated timelines, including mitigation efforts and economic effects, including but not limited to our preclinical studies and future clinical trials; and our plans to develop and commercialize our current product candidates and any future product candidates and the implementation of our business model and strategic plans for our business, current product candidates and any future product candidates, and other risks concerning iTeos' programs and operations that are described in additional detail in our Quarterly Report on Form 10-Q and our other filings made with the Securities and Exchange Commission from time to time. Although our forward-looking statements reflect the good faith judgment of management, these statements are based solely on facts and circumstances currently known to iTeos. As a result, you are cautioned not to rely on these forward-looking statements.  Any forward-looking statement made in this press release speaks only as of the date on which it is made.  iTeos undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, the occurrence of certain events or otherwise.

    For further information, please contact:

    Investor Contacts:

    Sarah McCabe, Zofia Mita

    Stern Investor Relations, Inc.

    + 1 212 362 1200

    iTeos@sternir.com

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700

    iteos@consilium-comms.com

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