FOXM1

Positive data from the ROSALIE Phase 1/2 trial presented at 2023 SNO Annual Meeting Median survival of 14.5 months and 18-months survival rate of 43.1% in a 26-patient cohort where EO2401 was administered in combination with nivolumab+bevacizumab PARIS, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced updated efficacy data from its Phase 1/2 clinical trial of EO2401, in combination with an immune checkpoint inhibitor (nivolumab) +/- an anti-VEGF therapy (bevacizumab), for the treatment of patients with first progression/recurrence of glioblastoma (ROSALIE trial). The data were featured in an oral presentation at the Society for Neuro-Oncology (SNO) Annual Meeting, in Vancouver, British Columbia, Canada, on November 17th. The presentation entitled “EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in first recurrent glioblastoma: the Phase 1/2 EOGBM1-18/ROSALIE study” was delivered by David Reardon, M.D., Professor of Medicine at Harvard Medical School and Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute. “We are very pleased to present extensive data from the Phase 1/2 ROSALIE study of EO2401, our lead OncoMimics™ peptide-based immunotherapy, in glioblastoma,” said Pierre Belichard, Chief Executive Officer of Enterome. “EO2401 continues to generate strong, durable, and target-specific immune responses associated with encouraging efficacy. Based on the promising results presented at SNO 2023, which include an 18-months survival rate of 43%, we now look forward to developing a registrational path for EO2401.” Prof. David Reardon, lead investigator of the study and presenting author, commented: “Recurrent glioblastoma is one of the most challenging cancers to treat. It is encouraging to see that the robust and durable immune response observed in a significant percentage of patients could translate into promising clinical outcome in the ROSALIE study. Our hope is now that the improvement in survival associated with the combination regimen of EO2401 with nivolumab and bevacizumab will convert into meaningful therapeutic benefit for patients with brain tumors in large scale studies.” Key highlights from the presentation delivered at SNO conference: EO2401 in combination with nivolumab and bevacizumab, as administered to 26 patients with recurrent glioblastoma comprising Cohort 3 of the ROSALIE study, was well tolerated with a safety profile consistent with the profile of nivolumab and bevacizumab, with the addition of local administration site reaction.The combination demonstrated encouraging results including a median survival of 14.5 months, median duration of response of 13.1 months, and median progression-free survival (PFS) of 5.5 months.The survival rate of 57.4% and 43.1% was observed at 12 months and 18 months respectively.EO2401/nivolumab generated fast, strong, and durable systemic immune responses against the targeted tumor-associated antigens IL13Rα2, BIRC5/survivin, and FOXM1.In Cohort 3, 23 patients (92% of tested, 88% of total) had a specific CD8+ T cell response against EO2401 and all of those patients (100%) had CD8+ T cells cross-reactive with the targeted TAAs, i.e., recognizing IL13Rα2, BIRC5/survivin, and/or FOXM1. About ROSALIE ROSALIE (EOGBM1-18) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo®) +/- bevacizumab for the treatment of patients with first progression/recurrence of glioblastoma. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in 100 patients enrolled at 10 clinical sites in Europe and the US. Enrollment was completed in December 2022. For more information on the Phase 1/2 trial of EO2401 in recurrent glioblastoma, please refer to ClinicalTrials.gov Identifier: NCT04116658 About OncoMimics™ OncoMimics™ immunotherapies are designed to activate pre-existing effector memory T cells that target bacterial (non-self) peptides, which are strongly cross-reactive against selected Tumor-Associated Antigens (TAAs), or B cell markers expressed on tumoral cells, resulting in a rapid, targeted cytotoxic response against cancer. Contacts ENTEROMEMEDIA RELATIONSGuillaume BayreHead of External CommunicationsTel: +33 (0)1 76 21 58 15communication@enterome.comLifeSci Advisors LLCAshley R. Robinson (US)+1 617 430 7577arr@lifesciadvisors.com Sandya von der Weid (Europe)+41 78 680 05 38svonderweid@lifesciadvisors.com About Enterome Enterome is a clinical-stage biopharmaceutical company developing breakthrough immunomodulatory drugs for the treatment of cancer and immune diseases. Enterome’s pioneering approach to drug discovery is based on its unique and powerful bacterial Mimicry drug discovery platform, which allows it to analyze and uncover new biological insights from the millions of gut bacterial proteins in constant cross-talk with the human body. Enterome’s first-in-class small protein and peptide drug candidates modulate the immune system by closely mimicking the structure, effect or actions of specific antigens, hormones, or cytokines. The company’s two pipelines of drug candidates include: OncoMimics™ peptides, a pipeline of peptide-based immunotherapies. Lead candidate, EO2401, is in Phase 2 clinical trials in patients with glioblastoma and adrenal tumors and has demonstrated clinical proof of concept. EO2463 is in a Phase 2 clinical trial for indolent non-Hodgkin lymphomas, and has demonstrated a good safety profile with first signs of efficacy. EO4010 is in clinical development for third-line colorectal cancer and EO2040 is in a Phase 2 trial in patients suffering from colorectal cancer with ctDNA-defined, minimal residual disease.EndoMimics™ peptides, a pipeline of next generation bioactives acting like human hormones or cytokines, are being developed in collaboration with Nestlé Health Science, for food allergies and inflammatory bowel disease (IBD). The lead candidate, EB1010, is expected to enter clinical development in 2024. Enterome employs 70 people and is headquartered in Paris, France. Since its inception, the company has raised a total of €118 million from Europe- and US-based life science investors and more than €100 million from pharmaceutical partnerships. For more information, please visit the company’s website at: www.enterome.com

Updated results demonstrate sustained efficacy with a good safety pro > Degree of tumor shrinkage on CT scans correlates with strength of CD8+ T cell specific immune response against EO2401 supporting the notion that efficacy is directly driven by EO2401, i.e., validating the OncoMimics approach PARIS, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced updated, encouraging results from Phase 1/2 SPENCER trial of EO2401 in combination with nivolumab in adrenocortical carcinoma (ACC) and metastatic pheochromocytoma/paraganglioma (MPP), two forms of adrenal tumors. EO2401 is composed of three non-self, microbiome-derived HLA-A2 restricted peptides, designed to activate memory CD8 T cells targeting tumor-associated antigens (TAAs) upregulated in adrenal tumors. The data was featured in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023. The presentation entitled, “EO2401 (E) peptide immunotherapy + nivolumab (N) in adrenocortical carcinoma (ACC) and metastatic pheochromocytoma/paraganglioma (MPP); EOADR1-19/SPENCER” was delivered by Prof. Eric Baudin, Head of the Endocrine Oncology Unit at Gustave-Roussy, Villejuif, France. “We are excited to share positive, updated results from the SPENCER trial at this year’s ESMO Congress,” said Pierre Belichard, Chief Executive Officer of Enterome. “EO2401 in combination with nivolumab continues to demonstrate a meaningful anti-tumor activity in patients with adrenal tumors. The combination was well-tolerated and generated durable immune responses.” Dr. Eric Baudin, Associate Professor and Head of the Endocrine Oncology Unit at Gustave-Roussy, commented: “The results presented at ESMO are very encouraging. The data represents a clinical validation of EO2401 as demonstrated by the correlation between the strength of immune response and degree of tumor shrinkage on CT scans, a direct measure of tumor activity.” Conclusion as presented at the ESMO conference: EO2401 in combination with nivolumab was generally well tolerated in patients with advanced/metastatic adrenal tumors Encouraging results in pretreated patients with ACC; median duration of disease control of 9 months, and 3 of 26 patients stopped study treatment at 2 years only due to protocol Longer follow-up needed to interpret results in pheochromocytoma/paraganglioma patients EO2401 in combination with nivolumab achieved long term stabilizations of “cold tumors” (TMB-low, MSS, PDL1-low adrenal tumors; ACC and MPP) Specific CD8 T cell immune responses could be a biomarker About SPENCER SPENCER (EOADR1-19) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab) for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in sites in Europe and the US. For more information on the Phase 1/2 trial of EO2401 in adrenocortical carcinoma, please visit ClinicalTrials.gov Identifier: NCT04187404 About EO2401 EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics™ peptide-based immunotherapy. It combines three microbial-derived OncoMimics™ peptides that closely mimic specific cytotoxic T cell (CD8+ T cell) epitopes on the Tumor-Associated Antigens IL13Ra2, BIRC5, and FOXM1, combined with the helper peptide (CD4+ T cell epitope) Universal Cancer Peptide 2 (UCP2). About OncoMimics™ OncoMimics™ immunotherapies are designed to activate pre-existing effector memory T cells that target bacterial (non-self) peptides, which are strongly cross-reactive against selected Tumor-Associated Antigens (TAAs), or B cell markers expressed on tumoral cells, resulting in a rapid, targeted cytotoxic response against cancer. Contacts ENTEROME MEDIA RELATIONS Guillaume Bayre Head of External Communications Tel: +33 (0)1 76 21 58 15 communication@enterome.com LifeSci Advisors LLC Ashley R. Robinson (US) +1 617 430 7577 arr@lifesciadvisors.com Sandya von der Weid (Europe) +41 78 680 05 38 svonderweid@lifesciadvisors.com About Enterome Enterome is a clinical-stage biopharmaceutical company developing breakthrough immunomodulatory drugs for the treatment of cancer and immune diseases. Enterome’s pioneering approach to drug discovery is based on its unique and powerful bacterial Mimicry drug discovery platform, which allows it to analyze and uncover new biological insights from the millions of gut bacterial proteins in constant cross-talk with the human body. Enterome’s first-in-class small protein and peptide drug candidates modulate the immune system by closely mimicking the structure, effect or actions of specific antigens, hormones, or cytokines. The company’s two pipelines of drug candidates include: OncoMimics™ peptides, a pipeline of peptide-based immunotherapies. Lead candidate, EO2401, is in Phase 2 clinical trials in patients with glioblastoma and adrenal tumors and has demonstrated clinical proof of concept. EO2463 is in a Phase 2 clinical trial for indolent non-Hodgkin lymphomas, and has demonstrated a good safety pro first signs of efficacy. EO4010 is in clinical development for third-line colorectal cancer and EO2040 is in a Phase 2 trial in patients suffering from colorectal cancer with ctDNA-defined, minimal residual disease. EndoMimics™ peptides, a pipeline of next generation bioactives acting like human hormones or cytokines, are being developed in collaboration with Nestlé Health Science, for food allergies and inflammatory bowel disease (IBD). The lead candidate, EB1010, is expected to enter clinical development in 2024. Enterome employs 70 people and is headquartered in Paris, France. Since its inception, the company has raised a total of €118 million from Europe- and US-based life science investors and more than €100 million from pharmaceutical partnerships. For more information, please visit the company’s website at:

Oral Presentation at ESMO will feature updated results from Phase 1/2 SPENCER study PARIS, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced that updated data from its Phase 1/2 SPENCER study on EO2401, in combination with nivolumab in patients with adrenal tumors, will be presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2023, to take place on October 20-23, 2023 in Madrid, Spain. Oral Presentation details – Abstract 724O Title: EO2401 (E) peptide immunotherapy + nivolumab (N) in adrenocortical carcinoma (ACC) and metastatic pheochromocytoma/paraganglioma (MPP); EOADR1-19/SPENCER Presenter: Dr. Eric Baudin, Associate Professor and Head of the Endocrine Oncology Unit at Gustave Roussy (Villejuif, France) Session Title: Proffered Paper Session - NETs and endocrine tumors Presentation Date and Time: Sunday, October 22, 2023, at 9.30 am CET Location: Toledo Auditorium - Hall 3 The abstract was published today and is available on the ESMO website. About SPENCER SPENCER (EOADR1-19) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab) for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma (ACC), or malignant pheochromocytoma/paraganglioma (MPP). The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination at sites in Europe and the US. For more information on the Phase 1/2 trial of EO2401 in adrenal tumors, please refer to ClinicalTrials.gov Identifier: NCT04187404 About EO2401 EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics™ peptide-based immunotherapy. It combines three microbial-derived OncoMimics™ peptides that closely mimic specific cytotoxic T cell (CD8+ T cell) epitopes on the Tumor-Associated Antigens IL13Ra2, BIRC5, and FOXM1, combined with the helper peptide (CD4+ T cell epitope) Universal Cancer Peptide 2 (UCP2). About OncoMimics™ OncoMimics™ immunotherapies are designed to activate pre-existing effector memory T cells that target bacterial (non-self) peptides, which are strongly cross-reactive against selected Tumor-Associated Antigens (TAAs), or B cell markers expressed on tumoral cells, resulting in a rapid, targeted cytotoxic response against cancer. Contacts ENTEROME MEDIA RELATIONS Guillaume Bayre Head of External Communications Tel: +33 (0)1 76 21 58 15 communication@enterome.com LifeSci Advisors LLC Ashley R. Robinson (US) +1 617 430 7577 arr@lifesciadvisors.com Sandya von der Weid (Europe) +41 78 680 05 38 svonderweid@lifesciadvisors.com About Enterome Enterome is a clinical-stage biopharmaceutical company developing breakthrough immunomodulatory drugs for the treatment of cancer and immune diseases. Enterome’s pioneering approach to drug discovery is based on its unique and powerful bacterial Mimicry drug discovery platform, which allows it to analyze and uncover new biological insights from the millions of gut bacterial proteins in constant cross-talk with the human body. Enterome’s first-in-class small protein and peptide drug candidates modulate the immune system by closely mimicking the structure, effect or actions of specific antigens, hormones, or cytokines. The company’s two pipelines of drug candidates include: OncoMimics™ peptides, a pipeline of peptide-based immunotherapies. Lead candidate, EO2401, is in Phase 2 clinical trials in patients with glioblastoma and adrenal tumors and has demonstrated clinical proof of concept. EO2463 is in a Phase 2 clinical trial for indolent non-Hodgkin lymphomas, and has demonstrated a good safety pro first signs of efficacy. EO4010 is in clinical development for third-line colorectal cancer and EO2040 is in a Phase 2 trial in patients suffering from colorectal cancer with ctDNA-defined, minimal residual disease. EndoMimics™ peptides, a pipeline of next generation bioactives acting like human hormones or cytokines, are being developed in collaboration with Nestlé Health Science, for food allergies and inflammatory bowel disease (IBD). The lead candidate, EB1010, is expected to enter clinical development in 2024. Enterome employs 70 people and is headquartered in Paris, France. Since its inception, the company has raised a total of €118 million from Europe- and US-based life science investors and more than €100 million from pharmaceutical partnerships. For more information, please visit the company’s website at: