Enlivex Therapeutics provides business updates on clinical programs

Enlivex Therapeutics (ENLV) provided strategic updates on its clinical programs. Clinical collaboration with BeiGene (BGNE): The Company announced a clinical collaboration agreement with BeiGene on April 3, 2023 . 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 the evaluation of Allocetra in combination with tislelizumab. Sepsis: Expanding study population, amending protocol: The Company is currently working on an amendment to the protocol of its Phase II trial evaluating Allocetra in patients with sepsis. The amendment will include an increase in the patients’ SOFA score inclusion range, effectively allowing recruitment of patients with higher level of sepsis severity, and a change to two cohorts in lieu of the current four-cohort structure. The Company expects to submit the proposed protocol amendments to regulators in early Q2 2023 and does not expect a material timeline delay for top-line data readouts, which are expected in Q1 2024. Two Phase I/II clinical trials in patients with advanced stage solid tumors: timeline established: Following safety assessment of the first cohort, the Company received positive DSMB recommendation and IMOH clearance to continue its Phase I/II trial of Allocetra combined with chemotherapy in patients with peritoneal metastases arising from solid cancers. Recruitment of patients has been on-track, and the Company’s current estimation is to complete enrollment and announce data readouts by Q2 2024. In addition, following safety assessment of the first cohort in the second Phase I/II clinical trial, the Company received positive DSMB recommendation and IMOH clearance to continue that clinical trial, which is evaluating Allocetra as monotherapy and in combination with anti-PD1 checkpoint inhibitors in patients with advanced-stage solid tumors. Recruitment of patients has been on-track, and the Company’s current estimation is to complete enrollment in the intravenous-infusion monotherapy and low-dose combination cohorts by the end of Q2 2023.