Enterome Initiates Phase 2 Trial for EO2040 Immunotherapy in Colorectal Cancer, Focusing on Minimal Residual Disease Identified by ctDNA
Wednesday, July 12, 2023
Enterome, a clinical-stage company, has initiated a Phase 2 clinical trial called 'CLAUDE' at The University of Texas MD Anderson Cancer Center to evaluate their novel immunotherapy candidate, EO2040, in patients with colorectal cancer (CRC). EO2040 is an off-the-shelf immunotherapy that combines synthetic peptides known as OncoMimics™. These peptides mimic tumor-associated antigens (TAAs) and are designed to activate pre-existing effector memory T cells, which target cancer cells.
EO2040 consists of two OncoMimics™ peptides that correspond to CD8 HLA-A2 epitopes, showing molecular mimicry with the TAAs FOXM1 and BIRC5. It also includes universal cancer peptide 2 (UCP2), which represents the CD4+ epitope. The trial will assess the immunogenicity and preliminary efficacy of EO2040 in combination with nivolumab, an immune checkpoint inhibitor, as well as its efficacy as a monotherapy.
An innovative aspect of the CLAUDE trial is the use of liquid biopsy monitoring to measure circulating tumor DNA (ctDNA) clearance, which serves as an indicator of immunotherapy efficacy. ctDNA assays can detect minimal residual disease after the surgical removal of a tumor, even when patients appear to be free of disease radiographically. The presence of ctDNA after completion of curative therapy is highly predictive of cancer recurrence. The primary objective of the CLAUDE trial is to evaluate the six-month ctDNA clearance rate, which is a surrogate endpoint for disease-free survival prolongation.
Enterome aims to establish a significant OncoMimics™ franchise and develop a diverse pipeline of next-generation OncoMimics™ immunotherapies. The success of the CLAUDE trial may open opportunities in other major cancer types where ctDNA monitoring is utilized to detect residual disease after surgery and standard treatments.
Colorectal cancer is a prevalent malignancy, ranking as the third most common cancer in men and the second most common in women globally. Despite advancements in surgical techniques and adjuvant therapies, a significant proportion of patients with localized disease develop metastases, and the survival rate for recurring/metastatic disease remains low. Therefore, there is a pressing need for innovative treatment strategies like EO2040 in the field of CRC.
