Enlivex Therapeutics Ltd Stock Price, News & Analysis

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has received authorization from the Israeli Ministry of Health to start a Phase IIb clinical trial for Allocetra™ in sepsis patients. This multi-center, placebo-controlled trial aims to enroll up to 160 patients, assessing safety, tolerability, and efficacy over 28 days. The company previously reported impressive Phase Ib results, showing zero mortality in Allocetra™-treated patients compared to 27% in controls. Allocetra™ has also been evaluated for COVID-19 treatment, with recent Phase Ib results indicating positive outcomes for five patients.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has announced a Key Opinion Leader webinar on November 5, 2020, focusing on COVID-19 treatment options, featuring Dr. Carlos Cordon-Cardo from Mount Sinai hospital. The session will discuss findings from over 68,000 COVID-19 patients and the potential of Allocetra™ as a treatment for severe cases. Recent Phase Ib trial results show that all five patients treated with Allocetra™ recovered. A Phase II trial is underway to further evaluate Allocetra™ in combination with standard care for 24 patients. No severe adverse events were reported.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the dosing of the first two patients in a Phase II clinical trial of Allocetra for severe and critical COVID-19 patients. This multi-center study aims to recruit up to twenty-four patients to evaluate Allocetra alongside standard care, focusing on safety, tolerability, and efficacy. The trial follows a successful Phase Ib trial where all five patients recovered. No severe adverse events were reported. The trial will observe patients for 28 days post-administration.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that the Israeli Ministry of Health has authorized a Phase II clinical trial for Allocetra^TM targeting severe and critical COVID-19 patients. The trial aims to evaluate safety and efficacy, recruiting up to 24 patients. This follows positive results from a Phase Ib trial where all five treated patients recovered. Further details will be submitted to expedite regulatory review. The Phase Ib trial showed no severe adverse events, indicating a favorable safety profile for Allocetra^TM.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced positive outcomes from a clinical trial of its therapy Allocetra^TM on COVID-19 patients in severe/critical condition. In the trial, five patients experienced complete recovery and were discharged from the hospital after an average of 5.5 days (severe) and 8.5 days (critical). No severe adverse events were reported. Following these promising results, Enlivex plans to transition to a larger Phase II trial for COVID-19 patients, contingent upon regulatory approval. Allocetra^TM could fill a treatment gap for severe COVID-19 cases.

Enlivex Therapeutics Ltd. has received a notice of allowance for a new patent in China concerning its immunotherapy product candidate, ALLOCETRA. This patent is expected to provide enhanced intellectual property protection, covering methods, uses, and pharmaceutical compositions. The patent is anticipated to be issued in Q4 2020. ALLOCETRA aims to address unmet medical needs related to organ dysfunction and acute multiple organ failure due to conditions such as Sepsis and COVID-19, in addition to treating solid tumors through immunotherapy mechanisms.

Enlivex Therapeutics (Nasdaq: ENLV) announced the publication of compelling preclinical data demonstrating a 90% reduction in mortality using its Allocetra^TM treatment in a murine model of severe sepsis. The study highlights Allocetra^TM's effectiveness in resolving organ failure and cytokine storms, showing significant results in a clinically relevant cecal ligation and puncture (CLP) model. This data complements previous Phase Ib clinical trial outcomes, supporting Allocetra^TM's potential application in treating severe sepsis and COVID-19-related complications.

Enlivex Therapeutics announced that the Japan Patent Office has allowed a patent application for ALLOCETRA, their immunotherapy candidate. The patent will provide intellectual property protection for its use and pharmaceutical compositions. The company anticipates the patent to be issued in Q3 2020. ALLOCETRA is designed to target serious clinical indications, including organ dysfunction related to sepsis and COVID-19, as well as modulating the tumor microenvironment for solid tumors. Enlivex focuses on developing allogeneic drugs for immune system rebalancing.

Enlivex Therapeutics (Nasdaq: ENLV) will present a corporate overview at the Jefferies Virtual Healthcare Conference on June 4, 2020, at 8:00 AM ET.

A live webcast of the presentation can be accessed here.

Enlivex specializes in developing immunotherapy solutions aimed at rebalancing the immune system for severe conditions without approved treatments, including Cytokine Release Syndrome and solid tumors.