Cancer Immunotherapies by Design
iTeos Therapeutics is a next-generation immuno-oncology company developing innovative anti-cancer agents to fulfil the promise of immunotherapy by targeting the tumor microenvironment to improve the lives of people living with cancer.
The Company is targeting two key pathways by which cancer cells suppress the immune system.
introduction
Pipeline
iTeos focuses upon selected key mechanisms by which cancer cells suppress the immune system.
The identification of these mechanisms is based on gene expression profiles of immune cell subsets as they recognize tumor cell targets, protein expression in human tumors and demonstration of proof of concept by blocking these mechanisms in a variety of laboratory models.
| Program | Trial Design | Indications | Preclinical | Phase 1 | Phase 1b/2a | |
|---|---|---|---|---|---|---|
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Adenosine Pathway
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A2A Receptor Antagonist | |||||
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EOS-850
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Dose finding, PK/PD | Solid tumors | ||||
| +Pembro | PD-1 resistant | |||||
| +Pembro | IO-naïve patients | |||||
| +Pac-Carbo | TNBC | New Mechanism Inhibitor | ||||
| Oncology | ||||||
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Treg Targeting
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Anti-TIGIT mAb ADCC-enabled | |||||
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EOS-448
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Dose Finding, PK/PD | Solid tumors | Anti-CCR8 mAb ADCC-enabled | |||
| Oncology | ||||||
Our latest news
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A2A Inhibitor CorporateiTeos Therapeutics Presents Data from First-in-Human Study of A2A Receptor Antagonist at AACR Virtual Annual Meeting 2020
– Initial data from the dose escalation portion of the Phase 1/2a trial in 21 cancer patients with advanced solid tumors shows EOS-850 was well tolerated with no dose-limiting toxicities observed – – EOS-850 showed preliminary single-agent clinical benefit in seven patients who continue to present with at least stable disease; two partial responses in heavily-pretreated patients are ongoing – – Identification of recommended Phase 2 dose showing strong foundation for planned expansion cohorts to evaluate EOS-850 as a monotherapy and in combination for several solid tumor indications – Gosselies, Belgium and Cambridge, MA – April 27, 2020. iTeos Therapeutics, a privately-held clinical-stage biotechnology company developing novel cancer immunotherapies, announced today that it will present initial data from the Phase 1 portion of the study of its selective and differentiated A2A receptor antagonist, EOS-850, in a poster presentation at the American Association of Cancer Research (AACR) Virtual Annual Meeting 2020. “We are excited by these data from the Phase 1 portion of the study, in which our highly selective A2A antagonist, EOS-850, had a favorable tolerability profile, as well as promising clinical responses, in cancer patients with advanced solid tumors,” said Joanne Jenkins Lager, M.D., Chief Medical Officer of iTeos Therapeutics. “We have established a recommended Phase 2 dose that was well tolerated and demonstrated favorable target coverage. The single-agent activity, demonstrated by two partial responses in heavily pre-treated patients, shows that EOS-850 is an active drug with a good therapeutic index. These data set a strong foundation for moving into the next stage of development in several expansion cohorts, whether as a single agent or in combination with Merck’s KEYTRUDA® or chemotherapy standard of care agents.” The Phase 1 dose escalation portion of the EOS-850 trial enrolled 21 advanced cancer patients with solid tumors. The trial was a 3 + 3 design and patients were enrolled in five dose levels, receiving EOS-850 orally either once a day (QD) or twice a day (BID). Additional patients could be enrolled at previously cleared dose levels to better define safety, pharmacokinetics and pharmacodynamics. The dose levels tested were 20 mg and 40 mg QD, and 40 mg, 80 mg and 160 mg BID. The primary objectives of the Phase 1 portion of the study were to evaluate the safety and tolerability of EOS-850 and to determine a recommended Phase 2 dose. Secondary study objectives include pharmacokinetic and pharmacodynamic assessment of EOS-850 monotherapy and monotherapy efficacy activity of EOS-850. Summary of the Data Presented All QD and BID dose levels were well-tolerated with no grade 3 or 4 drug-related adverse events. No dose limiting toxicities were observed. Assessment of the pharmacodynamic effects of EOS-850 in assays assessing phosphorylation of CREB and cytokine production, performed by taking blood samples from patients at various time points following administration, demonstrated sustained inhibition of the A2A receptor. Pharmacokinetic analysis demonstrated good dose-proportionality through 80mg BID, the recommended Phase 2 dose. EOS-850 demonstrated preliminary evidence of single-agent activity in seven patients, each of whom had at least stable disease. Ongoing partial responses were seen in a patient with heavily pre-treated checkpoint inhibitor-refractory melanoma and in a patient with metastatic hormone- and chemotherapy-resistant prostate cancer. The abstract and video presentation details are as follows: Title: First in human study with EOS100850, a novel potent A2A antagonist, shows excellent tolerance and clinical benefit in immune resistant advanced cancers (CT152) Session: Phase I Clinical Trials Abstract #: 10228 Authors: Laurence Buisseret, et al. The video presentation and full abstract will be available on the AACR conference website as of 9:00 AM ET on Monday, April 27th. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA. EOS-850 Further Clinical Development Plans The primary and secondary endpoints of the dose escalation portion of the Phase 1/2a trial have been met at the recommended Phase 2 dose of 80mg BID. Based on these results, as well as the partial responses observed in two cancer patients with advanced disease, the Company is moving into the expansion cohorts of the study. These cohorts will test EOS-850 as a single agent and in combination with KEYTRUDA® (pembrolizumab) and in combination with chemotherapy. Indications for testing include checkpoint-resistant melanoma, metastatic hormone-resistant prostate cancer, triple-negative breast cancer, endometrial cancer and non-small cell lung cancer. The combination studies will include a safety evaluation of the combinations and then enroll patients in two-stage tumor-specific expansions. Preliminary results of these expansions are expected in the first half of 2021. About iTeos Therapeutics iTeos Therapeutics is a privately-held, clinical-stage biopharmaceutical company dedicated to transforming the lives of people living with cancer by designing and developing next generation immunotherapies targeting two key resistance pathways to checkpoint therapy: the adenosine pathway and regulatory T cells (Tregs). The Company’s lead program, EOS-850, is a potentially best-in-class adenosine A2A receptor antagonist currently in a Phase 1/2a trial. Its second program, a fully human ADCC-enabling anti-TIGIT antibody (EOS-448), entered the clinic in February 2020. The Company recently closed a $125 million Series B-2 financing from leading biotech investors including RA Capital, Boxer Capital, MPM Capital, Janus Henderson Advisors, RTW Investments, Invus, HBM Partners, Fund+, Vives II, SRIW and SFPI . iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium. For more information, please visit www.iteostherapeutics.com. For further information, please contact: Michel Detheux, CEO iTeos Therapeutics SA info@iteostherapeutics.com Amber Fennell, Paul Kidwell, Matthew Neal and Sukaina Virji Consilium Strategic Communications +44 203 709 5700 iteos@consilium-comms.com Sarah McCabe and Zofia Mita Stern Investor Relations, Inc. + 1 212 362 1200 iTeos@sternir.com
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A2A Inhibitor Corporate ResearchiTeos Therapeutics to Present Data from First- in-Human Study of A2A Receptor Antagonist at AACR Virtual Annual Meeting 2020
Gosselies, Belgium and Cambridge, MA – April 20, 2020. iTeos Therapeutics, a privately-held biotechnology company developing novel cancer immunotherapies, announces today that it will present initial data on the first-in-human study of its highly innovative and differentiated A2A receptor antagonist, EOS-850 in a virtual poster presentation at the upcoming American Association of Cancer Research (AACR) Virtual Annual Meeting 2020, taking place April 27-28th. The abstract and video presentation details are as follows: Title: First in human study with EOS100850, a novel potent A2A antagonist, shows excellent tolerance and clinical benefit in immune resistant advanced cancers (CT152) Session: Phase I Clinical Trials Abstract #: 10228 Authors: Laurence Buisseret, et al. The video presentation and full abstract will be available on the AACR conference website from 9:00 AM ET on Monday, April 27th. For further information, please contact: Michel Detheux, CEO iTeos Therapeutics SA info@iteostherapeutics.com Amber Fennell, Paul Kidwell, Matthew Neal and Sukaina Virji Consilium Strategic Communications +44 203 709 5700 iteos@consilium-comms.com Sarah McCabe and Zofia Mita Stern Investor Relations, Inc. + 1 212 362 1200 iTeos@sternir.com
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A2A Inhibitor Clinical Trials Corporate Financial Research TIGITiTeos Therapeutics Closes $125 Million Series B2 Financing
- Proceeds support advancing clinical development of next-generation cancer immunotherapies targeting A2A adenosine receptor and anti-TIGIT immune checkpoint - - Oversubscribed round co-led by new investors RA Capital Management and Boxer Capital - - New investors Janus Henderson Investors, RTW Investments and Invus also participated along with previous Series B investors including MPM Capital and HBM Partners - Cambridge, MA and Gosselies, Belgium – April 1, 2020 – iTeos Therapeutics Inc., a privately-held clinical-stage biotechnology company developing innovative cancer immunotherapies, announced today the closing of an oversubscribed Series B2 financing, which raised a total of $125 million. The Series B2 financing round was co-led by RA Capital Management and Boxer Capital, and included new investors Janus Henderson Investors, RTW Investments and Invus along with existing investors MPM Capital, HBM Partners, 6 Dimensions Capital, Curative Ventures, Fund+, VIVES Louvain Technology Fund, SRIW, and SFPI. Proceeds from the financing will support the Company's continued growth and advance the clinical development of its two lead product candidates, EOS-850, a best-in-class adenosine A2A receptor antagonist and EOS-448, an ADCC-enabled anti-TIGIT antibody. EOS-850 is currently being evaluated in a Phase 1/2 clinical trial both as a single agent and in combination in several solid tumor indications. The Company plans to initiate dosing for the combination cohorts for this trial in the second quarter of 2020. The Company also recently initiated the Phase 1 portion of a Phase 1/2 clinical study of EOS-448, currently being evaluated in patients with solid tumors and hematological malignancies. Proceeds from this financing will also support the advancement of additional first-in-class preclinical programs targeting the adenosine pathway and Tregs. "We are very pleased to have the strong support of this leading class of investors who share our excitement for the highly innovative oncology therapies we have developed at iTeos,” said Michel Detheux, PhD, President and Chief Executive Officer at iTeos. “We look forward to accelerating and expanding our clinical development efforts to identify the most promising indications and combinations for people suffering with cancer. This financing maximizes our ability to execute our development plans alone or in partnership.” "iTeos’ pipeline of best-in-class agents has the potential to usher in a new wave of immuno-oncology therapeutics and the Company is well-positioned to make a significant, positive impact in the treatment of patients with a wide variety of cancer types,” commented Derek DiRocco, Principal, RA Capital Management. “We are thrilled to collaborate with this experienced group of high-quality investors and partner with the iTeos management team as they continue to innovate and progress these exciting programs through clinical development.” “The iTeos team has done a remarkable job developing a pipeline of differentiated, potentially best-in-class cancer therapies,” said Aaron Davis, Co-Founder and Chief Executive Officer, Boxer Capital of the Tavistock Group. “We are pleased to be joining them as they continue to execute and implement their vision for transforming the cancer treatment landscape.” Derek DiRocco and Aaron Davis will join the iTeos Board as Non-Executive Directors. About iTeos Therapeutics iTeos Therapeutics is a privately-held, clinical-stage biopharmaceutical company dedicated to transforming the lives of people living with cancer by designing and developing next generation immunotherapies targeting two key resistance pathways to checkpoint therapy: the adenosine pathway and regulatory T cells (Tregs). The Company’s lead program, EOS-850, is a best-in-class adenosine A2A receptor antagonist currently in a Phase 1/2 study. Its second program, a fully human ADCC-enabling anti-TIGIT antibody (EOS-448), entered the clinic in February 2020. iTeos Therapeutics is headquartered in Cambridge, MA with a world-class research center in Gosselies, Belgium. For more information, please visit www.iteostherapeutics.com. About RA Capital Management RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies that are developing drugs, medical devices, and diagnostics. The flexibility of its strategy allows RA Capital to provide seed funding to startups and to lead private, IPO, and follow-on financings for its portfolio companies, both facilitating the crossover process and allowing management teams to drive value creation with fewer capital concerns from inception through commercialization. For more information, please visit https://www.racap.com. About Boxer Capital, LLC Boxer Capital, LLC is a private biotechnology investment fund based in San Diego, California that invents and invests in drug development across multiple therapeutic indications. Founded by the life sciences team at Tavistock Group in 2005, Boxer Capital maintains a concentrated portfolio of public and private companies. For more information, please visit www.boxercap.com. For further information, please contact: Michel Detheux, CEO iTeos Therapeutics SA info@iteostherapeutics.com Amber Fennell, Paul Kidwell, Matthew Neal and Sukaina Virji Consilium Strategic Communications +44 203 709 5700 iteos@consilium-comms.com Sarah McCabe and Zofia Mita Stern Investor Relations, Inc. + 1 212 362 1200 iTeos@sternir.com
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Clinical Trials Research TIGITiTeos Therapeutics Initiates Phase 1/2 Study with Highly Innovative Anti-TIGIT Antibody in Patients with Advanced Cancers
– First patient enrolled in dose escalation portion of Phase 1/2 study of EOS-448, an antagonist anti-TIGIT antibody that enables antibody dependent cellular cytotoxicity (ADCC) – – ADCC-enabled TIGIT programs are progressing into pivotal trials – – Initial clinical data expected in 1H 2021 – Cambridge, MA and Gosselies, Belgium – February 27, 2020 – iTeos Therapeutics Inc., a privately-held clinical-stage biotechnology company developing innovative cancer immunotherapies, announced today that it has enrolled the first patient in its Phase 1/2 study with EOS884448 (EOS-448), the company’s investigational ADCC-enabled antagonist anti-TIGIT antibody drug candidate. Michel Detheux, PhD, President and Chief Executive Officer of iTeos, commented: “EOS-448 is an ADCC-enabled antagonist anti-TIGIT antibody that has been designed to maximize the therapeutic benefit of blocking TIGIT checkpoint inhibitors while engaging Fcγ receptors. The importance of TIGIT as a target for next-generation immunotherapy is becoming increasingly apparent in our field and, alongside our best-in-class adenosine A2A receptor antagonist EOS-850, iTeos now has two highly innovative immunotherapy programs in clinical development for patients suffering with advanced cancers.” Joanne Lager, M.D., Chief Medical Officer of iTeos, added, “ADCC-enabled antagonist anti-TIGIT programs are emerging as promising new immuno-oncology therapies. In preclinical studies, EOS-448 promotes anti-tumor immunity both alone and in combination with other oncology therapies. We believe it is well-positioned to provide important new therapeutic options for cancer patients. We look forward to evaluating EOS-448 in our now initiated Phase 1/2 trial and to reporting initial safety and efficacy results in the first half of 2021.” About the EOS-448 Phase 1/2 Trial This Phase 1/2 study of EOS-448 is an open-label, dose-escalation study to assess the safety, pharmacokinetic, pharmacodynamic and preliminary clinical activity of EOS-448 in participants with advanced cancers. Participants’ tumors will be sampled before treatment and during treatment, to identify and confirm biomarkers to be used in further clinical development. Following dose escalation and determination of the recommended Phase 2 dose, the study design allows for the seamless expansion of patient cohorts to evaluate the anti-tumor activity of EOS-448 in specific tumor types. The trial will be conducted at multiple clinical sites in Europe and is expected to enroll approximately 30 patients with advanced cancer in the dose escalation portion. About TIGIT and EOS-448 TIGIT is an immune checkpoint inhibitor, which interacts with CD155 expressed on antigen-presenting cells or tumor cells to down-regulate T cell and Natural Killer (NK) cell functions. EOS-448 is a novel fully human IgG1 mAb against the TIGIT receptor to treat a wide range of tumor types expressing ligands of TIGIT and/or being infiltrated by TIGIT expressing immune cells. EOS-448 was designed to encompass multiple mechanisms to activate anti-tumor immunity, not only by restoring T cell effector functions, but also by depleting immunosuppressive Tregs or inducing direct cytotoxicity of TIGIT-expressing tumor cells and creating local inflammation by engaging Fcγ receptors on effector cells. During preclinical development, EOS-448 demonstrated potent competition with TIGIT-ligand binding as well as in vitro and ex-vivo ability to restore T cell function in human samples. EOS-448 has also confirmed preferred direct cytotoxicity on regulatory T cells when tested in human cancer samples and demonstrated a clean toxicity profile. EOS-448 has also demonstrated potent anti-tumor efficacy in a humanized mouse tumor model. For further information, please contact: Michel Detheux, CEO iTeos Therapeutics SA info@iteostherapeutics.com Amber Fennell, Paul Kidwell, Matthew Neal and Sukaina Virji Consilium Strategic Communications +44 203 709 5700 iteos@consilium-comms.com Sarah McCabe and Zofia Mita Stern Investor Relations, Inc. + 1 212 362 1200 iTeos@sternir.com
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CorporateiTeos Therapeutics to Present at Cowen 40th Annual Health Care Conference
Cambridge, MA and Gosselies, Belgium – February 24, 2020 – iTeos Therapeutics SA, a privately-held biotechnology company developing innovative cancer immunotherapies, today announced that Michel Detheux, Ph.D., president and chief executive officer, will present at the upcoming Cowen 40th Annual Health Care Conference on Monday, March 2, 2020 at 3:30 p.m. ET in Boston, MA For further information, please contact: Michel Detheux, CEO iTeos Therapeutics info@iteostherapeutics.com Amber Fennell, Catherine Day, Matthew Neal and Sukaina Virji Consilium Strategic Communications +44 203 709 5700 iteos@consilium-comms.com Sarah McCabe Stern Investor Relations, Inc. +1 212 362 1200 sarah.mccabe@sternir.com
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CorporateiTeos Therapeutics to Present at SVB Leerink 9th Annual Global Healthcare Conference
Cambridge, MA and Gosselies, Belgium – February 18, 2020 – iTeos Therapeutics SA, a privately-held biotechnology company developing innovative cancer immunotherapies, today announced that Michel Detheux, Ph.D., president and chief executive officer, will present at the upcoming SVB Leerink 9th Annual Global Healthcare Conference on Tuesday, February 25, 2020 at 2:15 p.m. ET in New York, NY. For further information, please contact: Michel Detheux, CEO iTeos Therapeutics info@iteostherapeutics.com Amber Fennell, Paul Kidwell, Matthew Neal and Sukaina Virji Consilium Strategic Communications +44 203 709 5700 iteos@consilium-comms.com Sarah McCabe Stern Investor Relations, Inc. +1 212 362 1200 sarah.mccabe@sternir.com
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A2A Inhibitor Clinical Trials Financial Research TIGITiTeos Therapeutics Awarded €15 Million in Non-Dilutive Funding by the Walloon Region
Funds will be used to progress iTeos’ two highly innovative clinical-stage oncology programs: a best-in class A2A receptor antagonist and an ADCC-enabled anti-TIGIT antibody drug candidate Gosselies, Belgium and Cambridge, MA – January 30, 2020 – iTeos Therapeutics SA, a privately-held biotechnology company developing innovative cancer immunotherapies, today announced that it has been awarded a total of €15 million in non-dilutive funding to support the clinical development of its two proprietary anti-cancer drug programs, targeting key mechanisms of immunosuppression that are gaining prominence within industry development pipelines. The funding has been approved on behalf of the Walloon Region by Willy Borsus, Minister of Economy and Research. Funding of €11.5 million has been awarded to progress iTeos’ lead candidate EOS-850, a best-in-class adenosine A2A receptor antagonist, and will be used to support the ongoing phase 1b/2a clinical trial, underway at four sites across Europe, and will soon expand to clinical sites in the United States. A second award of €3.5 million will support the Phase 1 clinical trial of iTeos’ fully-human ADCC-enabled anti-TIGIT antibody (EOS-448), which is expected to start in Belgium in February 2020. Michel Detheux, Ph.D., Chief Executive Officer of iTeos, commented, “We are grateful to the Walloon Region for its continued support of iTeos Therapeutics. This investment is invaluable as we seek to progress our two clinical programs. During the last three years, iTeos has developed a comprehensive portfolio of immuno-oncology drug candidates, and these additional Walloon region funds will help us evaluate the performance of our promising lead programs in the clinic.” For further information, please contact: Michel Detheux, CEO iTeos Therapeutics info@iteostherapeutics.com Amber Fennell, Catherine Day, Matthew Neal and Sukaina Virji Consilium Strategic Communications +44 203 709 5700 iteos@consilium-comms.com Sarah McCabe Stern Investor Relations, Inc. +1 212 362 1200 sarah.mccabe@sternir.com
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Clinical TrialsiTeos Therapeutics Announces Collaboration with Merck Investigating the Combination of its A2A Antagonist with KEYTRUDA®
- Study will evaluate the safety and efficacy of the combination of iTeos’ EOS100850 and Merck’s KEYTRUDA® (pembrolizumab) Gosselies, Belgium and Cambridge, Mass. – Dec. 12, 2019 – iTeos Therapeutics SA, a privately-held biotechnology company developing novel cancer immunotherapies, announced today that it has entered into an agreement with a subsidiary of Merck, known as MSD outside the United States and Canada, to evaluate the safety and efficacy of EOS100850, iTeos’ investigational A2A receptor antagonist, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with solid tumors. The Phase 1/2 trial will enroll patients with multiple solid tumors, with the initial goal of determining the safety and tolerability of the combination therapy. The trial is expected to begin enrollment in early 2020. Joanne Jenkins Lager, M.D, Chief Medical Officer of iTeos Therapeutics, commented: “We believe that our differentiated, selective A2A receptor antagonist will be complementary to a range of immuno-oncology approaches and we are excited to initiate our first combination study of EOS100850 with KEYTRUDA®. Unlike other A2A antagonists, EOS100850 was purposely designed to have very high potency in the tumor micro-environment and unique selectivity for the A2A receptor. We look forward to evaluating how these two agents interact and complement each other as they have distinct mechanisms to overcome immunosuppression in the tumor microenvironment.” iTeos’ lead therapeutic candidate, EOS100850, is a non-brain penetrant A2A receptor antagonist that retains high potency in the presence of elevated adenosine concentrations such as those measured in the tumor microenvironment. It is currently in a Phase 1/1b study as a monotherapy. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA. *** About the iTeos Adenosine A2A Receptor Antagonist (EOS100850) The high level of adenosine in the microenvironment of many tumors plays a significant role in tumor immune evasion. The adenosine A2A receptor is the primary adenosine receptor expressed on immune cells. In the presence of adenosine, this receptor suppresses T cell activity. In preclinical studies, EOS100850, iTeos’ A2A receptor antagonist, restores T cell activity and promotes anti-tumor activity in preclinical models, as well as synergizing with several immune-checkpoint inhibitors and chemotherapy. Preliminary evidence of clinical activity has been described in kidney, lung and prostate cancer in clinical studies of A2A receptor antagonists and other agents targeting the adenosine axis. In contrast to other clinical-stage A2A receptor antagonists, EOS100850 retains high potency in the presence of elevated adenosine concentrations measured in the tumor microenvironment and is non-brain penetrant. EOS100850 has been extensively evaluated for safety, efficacy and oral bioavailability in numerous preclinical models. For information on EOS100850 clinical trials, please visit www.clinicaltrials.gov. For further information, please contact: Michel Detheux, CEO iTeos Therapeutics info@iteostherapeutics.com Amber Fennell, Catherine Day, Matthew Neal and Sukaina Virji Consilium Strategic Communications +44 203 709 5700 iteos@consilium-comms.com Sarah McCabe Stern Investor Relations, Inc. +1 212 362 1200 sarah.mccabe@sternir.com
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Corporate
iTeos Therapeutics to Present at Piper Jaffray 31st Annual Healthcare Conference
Cambridge, MA and Gosselies, Belgium – November 26, 2019 – iTeos Therapeutics SA, a privately-held biotechnology company developing novel cancer immunotherapies, today announced that Michel Detheux, Ph.D., President and Chief Executive Officer, will present at the upcoming Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 10:50 a.m. ET in New York, NY.