Enlivex Therapeutics Ltd. has made a significant breakthrough in their pioneering macrophage reprogramming immunotherapy clinical trial, as an independent Data and Safety Monitoring Board has completed the review of data from the first cohort of patients with advanced-stage solid tumors. The Israeli Ministry of Health has also given approval to continue the study and open additional cohorts, paving the way for further clinical trials of the revolutionary AllocetraTM treatment.
The first cohort of the AllocetraTM study has shown encouraging safety results, with no dose-limiting toxicities recorded during the one-week period following the last administration of three once-weekly, low starting doses of AllocetraTM as monotherapy. The primary objective of this dosing regimen was to determine the all-important safety profile, which could potentially pave the way for an increase in the AllocetraTM dosage level and discover any indications of effect. With a total follow-up time of 21 days, the DSMB has reviewed the available safety data for these three enrolled patients and given the study the green light.
The first cohort of the study yielded no mortalities or safety signals, prompting the DSMB to recommend its continuation. Upon review of the safety data, the IMOH granted clearance to recruit patients into the two subsequent cohorts, both of which will receive higher doses of AllocetraTM – one as monotherapy, the other in combination with anti-PD1 therapy. With no casualties or adverse reactions identified, the study is set to progress with the utmost confidence.
Enlivex CEO Oren Hershkovitz, Ph.D., expressed his excitement over the impressive safety profile of AllocetraTM revealed by the first three patients enrolled in the trial. He eagerly looks forward to the administration of higher doses in the next two cohorts of patients, with hopes of obtaining further safety data and a potential indication of effect.
ABOUT THE PHASE I/II TRIAL
The Phase I/II trial is a groundbreaking, open-label, dose escalation study that is set to enroll up to 48 advanced solid tumor patients across two stages. In Stage 1, participants will receive escalating doses of Allocetra™ monotherapy intravenously or intraperitoneally once a week for three consecutive weeks. In Stage 2, patients will be given escalating doses of Allocetra™ alongside anti-PD1 therapy. The primary objective of the trial is to evaluate safety and tolerability throughout the entire treatment period, as well as through one week after the last dose. Secondary endpoints include efficacy assessments, such as best overall response rate, progression-free survival, and overall survival. An exploratory endpoint of changes in immune cell/cytokine profiling in peritoneal fluid will also be assessed. The trial population includes adults with advanced, unresectable or metastatic solid tumors who have relapsed or have been refractory to available standard therapies, or who are not eligible for, or who have declined additional systemic therapy.
ABOUT ALLOCETRA™
Allocetra™ is an exciting new cell therapy that could revolutionize the way we treat diseases like solid cancers, sepsis, and more. By reprogramming macrophages back into their homeostatic state, Allocetra™ has the potential to provide a unique, effective solution to life-threatening medical conditions that are currently without adequate treatment options. Whether used as a stand-alone therapy or in combination with other leading medicines, Allocetra™ could be the breakthrough we’ve all been waiting for.
ABOUT ENLIVEX
Enlivex is on the cutting edge of medical breakthroughs with their revolutionary macrophage reprogramming immunotherapy. Allocetra™ is a universal, off-the-shelf cell therapy that helps restore balance to the immune system by resetting non-homeostatic macrophages into their homeostatic state. This groundbreaking technology can help provide hope and relief for those suffering from life-threatening conditions.