On July 11, 2023 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer and immune diseases based on its unique Mimicry platform, reported that the first patient has been dosed at The University of Texas MD Anderson Cancer Center (Houston, TX) in the Phase 2 ‘CLAUDE’ trial evaluating EO2040, the Company’s fourth OncoMimics immunotherapy candidate to enter clinical development (Press release, Enterome, JUL 11, 2023, View Source [SID1234633161]). The CLAUDE trial will assess the immunogenicity and the preliminary efficacy of EO2040 in combination with nivolumab and as a monotherapy in patients with circulating tumor DNA (ctDNA) defined minimal residual disease (MRD) stage II-IV colorectal cancer (CRC) after completion of surgical resection and all other standard of care treatments.
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EO2040 is an innovative, off-the-shelf immunotherapy that combines two synthetic OncoMimics peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the tumor-associated antigens (TAAs) FOXM1 & BIRC5. EO2040 also includes universal cancer peptide 2 (UCP2), a helper peptide representing the CD4+ epitope.
The CLAUDE study (EOCRC1-22; NCT05350501) is the first trial to use liquid biopsy monitoring to measure ctDNA clearance as an indicator of OncoMimics immunotherapy efficacy. A total of 34 patients are expected to be enrolled in this multi-center, open-label Phase 2 study in the US and Europe.
Circulating tumor DNA (ctDNA) assays can reveal minimal residual disease after surgical resection of a tumor in patients who appear radiographically free of disease, by detecting and analyzing traces of tumor DNA in a blood sample. Detection of ctDNA after completion of curative-intent therapy predicts with nearly 100% specificity the risk of cancer recurrence. The lead time between ctDNA detection and radiographic evidence of cancer recurrence is up to nine months, providing a window for the evaluation of novel therapeutic strategies.
The primary objective of the CLAUDE trial is to assess the six-month ctDNA clearance rate – with ctDNA clearance being used as a surrogate endpoint for prolongation of disease-free survival (DFS). ctDNA clearance is characterized by the disappearance of all somatic mutations identified in the blood, as well as no appearance of any additional new somatic mutations, and radiographic investigations showing no evidence of CRC.
Dr Pierre Belichard, CEO of Enterome, said: "We are delighted to begin a new clinical study to evaluate the potential of our new OncoMimics immunotherapy EO2040 to treat a second colorectal cancer indication. This latest trial is particularly interesting due to its use of liquid biopsy monitoring to measure ctDNA clearance as an indicator of treatment efficacy. If CLAUDE is successful, then it could open multiple opportunities in other major cancer indications where the use of ctDNA monitoring to detect residual disease after surgery and other standard of care treatment is used. This would support Enterome’s ambition to build a significant and valuable OncoMimics franchise and provide the Company with a uniquely differentiated position and ability to deliver a broad pipeline of next-generation OncoMimics immunotherapies."