ITOS iTeos Therapeutics Inc.

23.1
-0.87  -4%
Previous Close 23.97
Open 24.27
52 Week Low 17.5
52 Week High 47.61
Market Cap $810,786,877
Shares 35,098,999
Float 19,952,081
Enterprise Value $524,652,445
Volume 161,405
Av. Daily Volume 268,961
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Upcoming Catalysts

Drug Stage Catalyst Date
EOS-850 and pembrolizumab
Solid tumors
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
EOS-448
Solid tumors
Phase 1/2
Phase 1/2
Phase 1/2a initial data presented at AACR meeting April 10, 2021. 1/22 partial responses.

Latest News

  1. 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.

    Media Contacts:



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  2. 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.

    Media Contacts:

     



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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.

    Media Contacts:



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  3. – 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.

    Media Contacts:

    Chelsey Nostro

    W20 Group

    iTeos and iTeos logo are trademarks of iTeos Therapeutics Inc.



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  4. 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.

    Media Contacts:

    Amber Fennell, Paul Kidwell

    Consilium Strategic Communications

    +44 203 709 5700



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