Enlivex Therapeutics has received authorisation from the Spanish Agency of Medicines and Medical Devices (AEMPS) for the expansion of its ongoing Phase I/II clinical trial of Allocetra in subjects with advanced solid malignancies.
Allocetra is being developed as a universal, off-the-shelf cell therapy designed for reprogramming macrophages into their homeostatic state.
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Prior to the AEMPS’ clearance, the trial received IND clearance from the US Food and Drug Administration to recruit patients in the country.
The independent Data Safety Monitoring Board has also concluded its prespecified data review for the initial patient cohort in the Phase I/II trial.
Additionally, the Israeli Ministry of Health provided regulatory clearance for trial continuation and the opening of the subsequent high dose monotherapy and combination cohorts, after reviewing the data.
The Phase I/II multi-centre trial has been designed for assessing the tolerability, safety, and preliminary efficacy of Allocetra alone, and along with a PD1 checkpoint inhibitor, in advanced solid tumour patients.
Enlivex initiated this trial following encouraging preclinical studies that were carried out in partnership with the Yale Cancer Center.
These studies demonstrated a substantial and statistically significant survival benefit when the therapy was combined with a PD1 checkpoint inhibitor in a murine model of ovarian cancer.
Additional models showed a statistically significant survival benefit when combined with a PD1 or CTLA-4 checkpoint inhibitors in a murine peritoneal mesothelioma model.
Enlivex Therapeutics Medical vice-president Einat Galamidi said: “We are pleased with the AEMPS’ regulatory clearance to expand our clinical trial into Spain.
“We believe that Allocetra has the potential to provide a paradigm shift in treatment of advanced solid tumours, and we look forward to data readouts, including safety and potential indication of effect in patients, currently expected during 2023 and 2024.”
