On Janaury 25, 2023 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that an independent Data and Safety Monitoring Board (DSMB) has completed its prespecified data review for the first cohort of patients in the Company’s ongoing Phase I/II cell therapy clinical trial of AllocetraTM in patients with advanced-stage solid tumors (clinicaltrials.gov Identifier: NCT05581719) (Filing, 6-K, Enlivex Therapeutics, JAN 25, 2023, View Source [SID1234626532]). The Israeli Ministry of Health (IMOH) also reviewed the data and provided regulatory clearance to continue the study and open the study’s additional cohorts.
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The DSMB based its review on available safety data for the three enrolled patients in the first cohort in which three, once-weekly, low starting doses of AllocetraTM were administered as monotherapy. The dose-limiting toxicity period extended for one week following the last administration with an overall follow-up of 21 days. The primary purpose of the dosing regimen for the first cohort was to establish a safety profile that may enable an increase in the AllocetraTM dosing level administered to additional patients in the study and potentially associate dose levels with indications of effect.
There were no mortalities nor DSMB-identified safety signals in the first cohort, and the DSMB recommended that the study continue as designed. Following the DSMB recommendation, the IMOH reviewed the safety data for the first cohort and provided a regulatory clearance to initiate the recruitment of patients into the two following cohorts in the study, both of which will be administered higher AllocetraTM doses – one as monotherapy and the other in combination with anti-PD1 therapy.
Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, "We are pleased with the safety profile of AllocetraTM as demonstrated in the first three patients in this trial. We look forward to initiating the next two cohorts in which higher doses of AllocetraTM will be administered in patients, allowing Enlivex to obtain additional safety data as well as a potential indication of effect."
ABOUT THE PHASE I/II TRIAL
The Phase I/II trial is a multicenter, open-label, dose escalation trial that is expected to enroll up to 48 patients with advanced solid tumors across two trial stages. Stage 1 of the trial will examine escalating doses of Allocetra monotherapy administered intravenously (IV) or intraperitoneally (IP) once a week for three consecutive weeks. Stage 2 will evaluate escalating doses of Allocetra administered IV or IP and combined with anti-PD1 therapy. Patients in Stage 2 will receive three injections of Allocetra concomitantly with the studied anti-PD1 agent. The primary objective of the study is to evaluate safety and tolerability throughout the treatment period and through one week after the last administration of Allocetra. Key secondary endpoints include efficacy assessments, such as best overall response rate, progression-free survival, and overall survival. Changes in immune cell/cytokine profiling in peritoneal fluid will also be assessed as an exploratory endpoint. The study population encompasses adult patients with advanced, unresectable or metastatic solid tumors that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for, or have declined additional standard-of-care systemic therapy.
ABOUT ALLOCETRA
Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.