Enterome Presents Positive Data from Phase 1/2 SPENCER Trial of EO2401 in Adrenal Tumors at ESMO 2023 Congress

Updated results demonstrate sustained efficacy with a good safety profile

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.

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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