On April 3, 2023 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, "Enlivex"), a clinical-stage macrophage reprogramming immunotherapy company, reported a clinical collaboration with BeiGene, to evaluate the safety and efficacy of Allocetra, an investigational macrophage-reprogramming cell therapy, in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor, for the treatment of patients with advanced-stage solid tumors (Press release, Enlivex Therapeutics, APR 3, 2023, View Source [SID1234629743]).
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"We are excited to explore the potential of Allocetra in combination with tislelizumab, a potentially differentiated PD-1 inhibitor," said Shai Novik, Executive Chairman of Enlivex. "We look forward to integrating tislelizumab into our ongoing Phase I/II clinical trial."
"Combinatorial approaches for fighting difficult-to-treat cancers historically have proven to be important in the delivery of better treatments to patients", said Oren Hershkovitz, Ph.D., CEO of Enlivex. "We believe that the preclinical data observed to date for Allocetra, with its unique macrophage-modulation properties, and immune checkpoints, support the evaluation of the combination for the treatment of patients with the tislelizumab-Allocetra combinations."
Under the terms of the clinical collaboration agreement, Enlivex has agreed to amend its ongoing Phase I/II trial in patients with advanced-stage solid tumors to include evaluation of Allocetra in combination with tislelizumab. 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. BeiGene will provide the clinical supply of tislelizumab for the trial.
ABOUT TISLELIZUMAB
Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
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.