The trial will enrol up to 48 advanced solid tumours patients. Credit: Atlas of Pulmonary Pathology/ Flickr (Creative Commons).

Enlivex Therapeutics and BeiGene have entered into a clinical collaboration to assess the efficacy and safety of combination of the former’s Allocetra™ along with tislelizumab to treat advanced-stage solid tumours.

Under the clinical collaboration deal terms, Enlivex agreed to amend its ongoing Phase I/II trial to include the investigation of the combination of Allocetra and tislelizumab, an anti-PD-1 immune checkpoint inhibitor.

The first stage of the dose escalation, multicentre, open-label Phase I/II trial will assess the escalating doses of Allocetra monotherapy given intravenously (IV) or intraperitoneally (IP) once a week for three consecutive weeks.

The second stage is designed to assess Allocetra escalating doses given IV or IP as well as in combination with tislelizumab.

Up to 48 advanced solid tumour patients are expected to be enrolled in the two trial stages.

BeiGene will be responsible for the clinical supply of tislelizumab for the trial.

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Enlivex Therapeutics CEO Oren Hershkovitz said: “Combinatorial approaches for fighting difficult-to-treat cancers historically have proven to be important in the delivery of better treatments to patients.

“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.”

Being developed as a universal, off the shelf cell therapy, Allocetra is designed for reprogramming macrophages into their homeostatic state.

It can offer a new immunotherapeutic mechanism of action for life-threatening clinical indications by restoring macrophage homeostasis.

The humanised IgG4 anti-PD-1 monoclonal antibody tislelizumab (BGB-A317) has been designed specifically for minimising the attachment to FcγR on macrophages.

It is currently being developed as a monotherapy as well as in combination with other therapies to treat a wide array of solid tumour and haematologic cancers.

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