Enlivex, BeiGene enter clinical collaboration agreement

Enlivex Therapeutics (ENLV) announced a new clinical collaboration agreement with Beigene (BGNE) to test a new combination treatment to fight advanced-stage solid tumors. The therapy will combine Allocetra, Enlivex’s novel macrophage reprogramming immunotherapy with tislelizumab, Beigene’s anti-PD-1 immune checkpoint inhibitor, with the goal of creating an even more potent cancer-fighting treatment than either immunotherapy on its own. Under the new agreement, Enlivex is amending its ongoing Phase 1/2a trial to now include tislelizumab in stage 2 of the clinical trial, one that will evaluate Allocetra and tislelizumab as a combination therapy. The multicenter, open-label trial will enroll approximately 48 patients with advanced-stage solid tumors across both trial stages. They will each get three escalating doses of either Allocetra alone or the combined Allocetra and tislelizumab. The ongoing Phase I/II trial is expected to complete enrollment for the standalone Allocetra stage and the initial low-dose combination therapy stage, with another anti-PD1 immune checkpoint, by the end of the second quarter. Once fully enrolled, the study’s primary goal is to measure the safety of Allocetra alone and as a combination therapy. But researchers will also track overall response rate, progression-free survival, overall survival and other measures of how effective the therapies were over a 12-month span following dosing.