Enterome presented encouraging interim results from its Phase I/II AUDREY trial, evaluating EO4010—a novel OncoMimics immunotherapy—in combination with Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) for patients with microsatellite stable (MSS) and mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC).
The data was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from 30 May to 3 June in Chicago (US).
Clinical trial data
The AUDREY trial (NCT05589597) is a multicenter, open-label Phase I/II study assessing the safety, tolerability, immunogenicity, and preliminary efficacy of EO4010, both as monotherapy and in combination with Opdivo, with or without bevacizumab (also known as Avastin), in patients with unresectable, previously treated MSS/pMMR mCRC.
The trial aims to enroll 42 patients, according to clinicaltrial.gov. The company presented data from the 20 patients who received EO4010 in combination with Opdivo, with or without bevacizumab.
At a median follow-up of 15.4 months, the 12-month survival rate stood at 40%, with a median overall survival of 11.3 months. Notably, 34% of patients remained alive at the time of reporting, indicating a potential plateau in survival curves.
The treatment demonstrated a favorable safety profile and was well-tolerated. Approximately 80% of patients exhibited specific immune responses against the targeted TAAs, underscoring the therapy’s immunogenic potential.
EO4010 is Enterome’s third clinical-stage OncoMimics candidate. It aims to address this by employing five synthetic peptides that mimic tumor-associated antigens (TAAs) commonly expressed in colorectal cancer: BIRC5, FOXM1, UBE2C, CDC20, and KIF2C. These peptides are designed to stimulate CD8+ T cells, enhancing the immune system’s ability to target and eliminate cancer cells.
The AUDREY trial is expected to be completed in the first half of 2026. Jan Fagerberg, MD, PhD, Chief Medical Officer of Enterome, said: “Objective response is a very rare event in immunotherapy in patients with MSS/pMMR mCRC; yet we observed direct tumor impact by EO4010 as measured by CT scan tumor shrinkages and CEA/CA19-9 tumor marker declines, including RECIST partial response in liver and lung metastases. This and the survival are exciting results and we look forward learning more about how to most effectively use EO4010 in CRC.”
