EO4010 / Enterome - LARVOL DELTA

AUDREY: EO4010 in Previously Treated Metastatic Colorectal Carcinoma (clinicaltrials.gov) - P1/2 | N=25 | Terminated | Sponsor: Enterome | N=42 ➔ 25 | Trial completion date: Feb 2026 ➔ May 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2026 ➔ May 2025; Sponsor decision to stop recruitment in context of overall EO4010 development goals. Stop of recruitment was not related to any safety concern, with the safety profile of EO4010 being benign

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Colorectal Cancer • Oncology • Solid Tumor

Survival of patients (pts) with microsatellite stable/mismatch repair proficient (MSS/pMMR) metastatic colorectal carcinoma (mCRC) treated with EO4010 + nivolumab (EO/N). (ASCO 2025) - P1/2 | " Pts had MSS/pMMR mCRC, treated with FU, oxaliplatin, irinotecan and anti-VEGF/EGFR. EO4010 + nivolumab promotes expansion of TAA specific CD8 T cells and shows good safety and interesting survival in previously treated MSS/pMMR mCRC. Data suggests a potential survival benefit associated with stronger EO4010-induced immune responses. Continued evaluation of EO is warranted; further immune testing data, and results of addition of bevacizumab to EO + N in a separate cohort are awaited."

Clinical • Metastases • Mismatch repair • pMMR • Colorectal Cancer • Fatigue • Myocardial Infarction • Oncology • Solid Tumor • BIRC5 • CA 19-9 • CD4 • CD8 • CDC20 • EGFR • FOXM1 • KIF2C • KRAS • UBE2C

Enterome presents positive Phase 1/2 MSS/pMMR metastatic colorectal cancer data in patients treated with EO4010 OncoMimics immunotherapy plus nivolumab at ASCO 2025 (GlobeNewswire) - P1/2 | N=42 | AUDREY (NCT05589597) | Sponsor: Enterome | "Enterome SA...announces it will present new positive data from its ongoing Phase 1/2 'AUDREY' trial...Data from 20 patients with MSS/pMMR mCRC enrolled in the open label AUDREY trial showed that EO4010 plus nivolumab, with or without bevacizumab, was well tolerated....EO4010 also generated fast, robust, and durable expansions of CD8+ T cells against the targeted TAAs causing clinically meaningful responses in this challenging patient population. Specifically, EO4010 plus nivolumab showed direct anti-tumor activity in MSS/pMMR mCRC. Survival in patients treated with EO4010 plus nivolumab at a median follow-up of 15.4 months, was 40% at 12-months and there is currently a plateau at 34% survival, with 7 of 20 patients still alive; the median survival is currently 11.3 months."

P1/2 data • pMMR • Colorectal Cancer

Enterome Presents Encouraging Initial Clinical Data on EO4010 in Colorectal Cancer at ESMO IO 2024 (GlobeNewswire) - P1/2 | N=42 | AUDREY (NCT05589597) | Sponsor: Enterome | "Enterome...announced that initial clinical data from the ongoing Phase 1/2 ‘AUDREY’ trial evaluating its innovative OncoMimics immunotherapy EO4010 in microsatellite stable metastatic colorectal cancer (CRC), will be presented at the ESMO Immuno-Oncology (IO) Congress, taking place in Geneva, Switzerland, December 11-13, 2024....Among the 17 patients evaluated in Cohort 2 of the AUDREY trial, one achieved a partial response, showing a 46% reduction in liver metastases, a 34% reduction in lung metastases, and normalization of carcinoembryonic antigen (CEA) levels. Two additional patients achieved stable disease; one demonstrated a 7% reduction in lung metastases and a marked reduction of tumor biomarkers CEA/CA19-9, while another maintained stable disease beyond 17 weeks. Six patients showed stable disease in target lesions, though with progression in non-target lesions, along with some biomarker reductions."

P1/2 data • Colorectal Cancer

AUDREY: EO4010 in Previously Treated Metastatic Colorectal Carcinoma (clinicaltrials.gov) - P1/2 | N=42 | Active, not recruiting | Sponsor: Enterome | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

AUDREY: EO4010 in Previously Treated Metastatic Colorectal Carcinoma (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Enterome | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2023 ➔ Jun 2023

Combination therapy • Enrollment open • Metastases • Trial initiation date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Enterome announces first patient dosed in a Phase 1/2 trial with third OncoMimics immunotherapy, EO4010, in Metastatic Colorectal Cancer (GlobeNewswire) - "Enterome...announces that the first patient was dosed in the Phase 1/2 'AUDREY' trial evaluating EO4010, the Company's third OncoMimics™ candidate, for the treatment of patients with unresectable, previously treated, metastatic colorectal cancer (CRC)....A total of 42 patients are expected to be enrolled in Europe and the US."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Enterome forms Scientific Advisory Board and Medical Advisory Group as it advances its OncoMimics immunotherapy pipeline for solid and liquid tumors (GlobeNewswire) - "Enterome...announces the creation of its international Scientific Advisory Board (SAB) and Medical Advisory Group (MAG) comprising highly respected and influential scientific and clinical leaders in oncology and immunotherapy. The newly formed SAB and MAG will provide strategic, scientific, and clinical guidance to Enterome as it progresses its pipeline of innovative OncoMimics™ immunotherapies targeting solid and liquid tumors....'In addition, we look forward to their input to the development strategies around our other OncoMimics candidates, which are planned to enter clinical trials in 2023, including EO2040 in colorectal cancer with ctDNA-defined, minimal residual disease, and EO4010 for third-line colorectal cancer'."

New trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

AUDREY: EO4010 in Previously Treated Metastatic Colorectal Carcinoma (clinicaltrials.gov) - P1/2 | N=42 | Not yet recruiting | Sponsor: Enterome

Combination therapy • New P1/2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor