Clinical stage biopharma company Enterome has presented new data from its two phase 1/2 clinical trials of its OncoMimics cancer immunotherapy EO2401.
The trails are in combination with nivolumab (Opdivo) +/- bevacizumab (Avastin), in patients with first progression/recurrence of glioblastoma (ROSALIE trial), and in combination with nivolumab in patients with non-resectable adrenocortical carcinomas (ACC) and metastatic pheochromocytoma/paraganglioma (MPP) (SPENCER trial).
The data were presented in a poster (ROSALIE) and an oral presentation (SPENCER) at the European Society for Medical Oncology (ESMO) Congress 2022, respectively, in Paris.
EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics cancer immunotherapy. It combines three OncoMimics peptides that closely mimic IL13Ra2, BIRC5 and FOXM1, all of which are known driver antigens present on aggressive solid tumors. In addition, EO2401 contains a CD4 helper peptide UCP2. Enterome selected these OncoMimics peptides using its Mimicry platform, which applies biocomputational tools and bioassays to identify novel therapeutics from its database of more than 20 million bioactive gut microbiome peptides and proteins.
‘Good safety profile’
Jan Fagerberg, chief medical officer of Enterome said: “We are excited that EO2401 therapy continues to show promising and sustained efficacy with a good safety profile. These data from the ROSALIE and SPENCER trials are providing important insights that will enable us to select appropriate treatment regimens and patient populations for the next clinical studies with EO2401 in solid tumor indications.”
Pierre Belichard, CEO of Enterome added: “The data presented at ESMO reinforces the positive findings that we communicated at ASCO in June and confirm the power of Enterome’s Mimicry platform to generate novel and highly promising cancer vaccine candidates. These promising data provide a compelling proof-of-concept for our unique Mimicry approach and give us confidence in our ability to generate an extensive pipeline of OncoMimics-based immunotherapies targeting unmet needs across a wide range of solid and hematologic cancers.
“Alongside EO2401, we are pursuing recruitment for EO2463 in B cell malignancies and plan to promptly start treating the first patient with ctDNA-defined, minimal residual disease in colorectal cancer with EO2040. We are also actively preparing the next OncoMimics candidate EO4010, developed for the treatment of colorectal cancer, to enter the clinic.”
EO2401/ROSALIE presentation details
Follow-up data confirm that EO2401 in combination with nivolumab +/- bevacizumab is well tolerated with a safety profile consistent with the safety profiles of nivolumab and bevacizumab.
EO2401, in combination with nivolumab, generated strong systemic immune responses through activation of specific effector memory CD8+ T cells, correlating with efficacy.
The addition of bevacizumab to EO2401 and nivolumab supported longer treatment durations, and an increase of objective response rate, disease control rate, and progression-free survival, with three of the first 11 patients showing complete remission.
Additional patients are to be treated with an EO2401/nivolumab/ bevacizumab combination to support final regimen selection for further studies.
EO2401 in combination with nivolumab is well tolerated in patients with ACC and MPP with a safety profile consistent with the safety profiles of nivolumab monotherapy.
Clinical efficacy was observed that correlates with the strength of generated immune responses.
The best efficacy was observed in a post-hoc defined subgroup of patients with ACC, including prolonged duration partial responses, and a 12-month survival rate of 78.6%, the highest achieved in any relevant study in this indication.
A randomized study to evaluate EO2401 in combination with nivolumab versus EO2401 monotherapy versus nivolumab monotherapy in this defined ACC population is ongoing.