Enlivex receives clearance from Spanish AEMPS for Phase I/II of Allocetra

Enlivex Therapeutics announced that the Spanish Agency of Medicines and Medical Devices, AEMPS, has authorized the expansion of the Company’s Phase I/II of Allocetra in patients with advanced solid malignancies. The clearance of the Phase I/II by the AEMPS follows recent announcements by the Company that the study received IND clearance from the U.S. Food And Drug Administration for recruitment of patients in the U.S., the independent Data Safety Monitoring Board has completed its prespecified data review for the first cohort of patients in the Phase I/II trial and the Israeli Ministry of Health had reviewed the data and provided regulatory clearance to continue the study and open the subsequent high dose monotherapy and combination cohorts. The Phase I/II multi-center clinical trial has been designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors. The Phase I/II trial was initiated following encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when Allocetra was combined with a PD1 checkpoint inhibitor in a murine model of ovarian cancer, and additional models that demonstrated statistically significant survival benefit when Allocetra was combined with a PD1 or CTLA-4 checkpoint inhibitors in a murine model of peritoneal mesothelioma. Einat Galamidi, MD., Vice President, Medical of Enlivex, stated "We are pleased with the AEMPS’ regulatory clearance to expand our clinical trial into Spain. We believe that AllocetraTM has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to data readouts, including safety and potential indication of effect in patients, currently expected during 2023 and 2024."