The study was designed to evaluate Allocetra alone and in combination with a PD1 checkpoint inhibitor in patients with advanced solid tumors. Photo credit: National Cancer Institute on Unsplash.
Enlivex Therapeutics has received approval from the Spanish Agency for Drugs and Medical Devices (AEMPS) to expand its ongoing Phase I/II clinical trial of Allocetra in patients with advanced solid malignancies.
Allocetra is being developed as a universal, ready-to-use cellular therapy designed to reprogram macrophages to their homeostatic state.
Prior to approval by AEMPS, the study received IND approval from the US Food and Drug Administration to enroll patients in the country.
The independent Data Safety Monitoring Board has also completed its mandatory data review for the first patient cohort in the Phase I/II study.
In addition, after reviewing the data, the Israeli Ministry of Health granted regulatory approval to continue the study and open subsequent high-dose monotherapy and combination cohorts.
The multi-centre, phase I/II study was designed to evaluate the tolerability, safety and preliminary efficacy of Allocetra alone and in combination with a PD1 checkpoint inhibitor in patients with advanced solid tumors.
Enlivex initiated this study following encouraging preclinical studies conducted in collaboration with the Yale Cancer Center.
These studies demonstrated a substantial and statistically significant survival benefit when therapy was combined with a PD1 checkpoint inhibitor in a mouse model of ovarian cancer.
Additional models demonstrated a statistically significant survival benefit in combination with a PD1 or CTLA-4 checkpoint inhibitor in a murine peritoneal mesothelioma model.
Einat Galamidi, Vice President of Enlivex Therapeutics Medical, said: “We are pleased with the regulatory approval from AEMPS to expand our clinical trial to Spain.
“We believe Allocetra has the potential to bring about a paradigm shift in the treatment of advanced solid tumors and we look forward to data reads, including safety and potential evidence of effect in patients, currently anticipated in 2023 and 2024.”
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