Enlivex Therapeutics Ltd. Ordinary Shares - ENLV STOCK NEWS

Enlivex Therapeutics (Nasdaq: ENLV) reported its full-year 2022 financial results and unveiled updates on clinical programs. A collaboration with BeiGene was announced on April 3, 2023, to explore Allocetra™, a cell therapy, in treating advanced-stage solid tumors. The company plans to amend its sepsis trial protocol to broaden patient inclusion and shift from four cohorts to two. Positive recommendations were received to continue two Phase I/II trials, with data readouts expected by Q2 2024. Research expenses rose to $18.6 million, with a net loss of $31 million for the fiscal year 2022. Cash reserves stood at $50.2 million as of year-end.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced a clinical collaboration with BeiGene to integrate Allocetra™, a macrophage-reprogramming cell therapy, into an ongoing Phase I/II trial for patients with advanced solid tumors. This trial will evaluate Allocetra in conjunction with tislelizumab, an anti-PD-1 immune checkpoint inhibitor. The study will involve up to 48 patients with escalated doses administered intravenously or intraperitoneally. Tislelizumab, developed to minimize binding to macrophages, aims to enhance anti-tumor activity. The collaboration underscores the potential of combinatorial cancer treatments and the unique properties of Allocetra.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) reported that an independent Data and Safety Monitoring Board has completed an interim review for its Phase I/II trial of Allocetra™, a macrophage reprogramming therapy, in patients with advanced-stage peritoneal metastasis. The Israeli Ministry of Health approved the continuation of the trial and allowed the escalation of Allocetra™ doses for the next patient cohort. No safety concerns were identified in the first cohort of three patients, supporting a move to higher doses. The trial seeks to evaluate safety and efficacy, with a total enrollment of 12 patients.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the Spanish Agency of Medicines and Medical Devices has approved the expansion of its Phase I/II trial for Allocetra™ in patients with advanced solid malignancies. This follows IND clearance from the FDA, and regulatory clearances from both the Israeli Ministry of Health and an independent Data Safety Monitoring Board for initial patient cohorts. Designed to evaluate Allocetra™'s safety, tolerability, and efficacy, the trial aims to assess both the standalone therapy and its combination with a PD1 checkpoint inhibitor. Results indicating safety and potential efficacy are expected in 2023 and 2024.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the issuance of an Israeli patent numbered 284985, valid until at least 2037. This patent covers the use of Allocetra™ for mitigating cytokine storms in cancer patients undergoing CAR-T therapy and those affected by various infectious diseases. The CEO, Oren Hershkovitz, expressed satisfaction with the expansion of Enlivex's intellectual property portfolio. Allocetra™ aims to reprogram macrophages into their homeostatic state, potentially benefiting severe conditions like solid cancers and sepsis.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that an independent Data and Safety Monitoring Board (DSMB) has completed its data review for the first cohort of patients in its Phase I/II trial of Allocetra™ for advanced solid tumors. No safety concerns were identified, and the Israeli Ministry of Health has granted regulatory clearance to proceed with additional patient cohorts. The trial will evaluate higher doses of Allocetra™ as both monotherapy and in combination with anti-PD1 therapy, with a total of 48 patients expected to be enrolled. Key endpoints include safety, tolerability, and various efficacy measures.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that ANSES and FAMHP approved the amended protocol for its Phase II trial of Allocetra™ in sepsis patients. The study's scope expands to include septic patients from biliary, urinary tract, or abdominal infections. The trial will enroll 80 to 160 participants across four cohorts, assessing safety and efficacy over 28 days. Previous Phase Ib results indicated improved clinical outcomes with Allocetra™ compared to standard care. CEO Oren Hershkovitz highlighted this regulatory achievement as validation of the trial's design.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced FDA clearance for its frozen-formulation Allocetra™ IND aimed at treating patients with advanced solid tumors. The IND includes a multi-center clinical trial in Israel, evaluating Allocetra™ alone and with a PD1 checkpoint inhibitor. Notable preclinical data showed a 55% survival rate in combination therapy for a mesothelioma model. The company also received regulatory approvals in Europe for amendments to its Phase II sepsis trial, expanding the patient population. As of September 30, 2022, Enlivex reported a net loss of $5.7 million and cash reserves of $57.7 million.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has announced that the FDA approved its Investigational New Drug (IND) application to study its cell therapy, Allocetra™, in patients with advanced solid tumors. This IND clearance follows positive preclinical studies in collaboration with Yale Cancer Center, showing significant survival benefits in murine models. The Phase I/II clinical trial aims to evaluate Allocetra™ alone and in combination with PD1 checkpoint inhibitors for patients with relapsed or refractory malignancies. This regulatory clearance marks a pivotal milestone in Enlivex's development trajectory.