Enlivex to Host COVID-19 Webinar: The Staging of a New Disease and Its Implications for Treatment Options, with Mount Sinai Key Opinion Leader

Rhea-AI Summary

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.

Positive

• All five patients in the Phase Ib trial completely recovered from severe/critical COVID-19 conditions and tested PCR negative.
• Allocetra™ was well-tolerated with no severe adverse events reported.
• The upcoming Phase II clinical trial aims to assess Allocetra™ in a larger patient group.

Negative

• None.

* Findings and Analyses On 68,000 COVID-19 Patients Discussed in the Webinar on Thursday, November 5^th @ 10amET *

Nes Ziona, Israel, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage immunotherapy company, today announced that it will host a Key Opinion Leader (KOL) webinar on COVID-19 and its implications for treatment options on Thursday, November 5, 2020 at 10am Eastern Time.

The webinar will feature a presentation by KOL Carlos Cordon-Cardo, MD, PhD, from Mount Sinai hospital, who will discuss his team’s findings in more than 68,000 COVID-19 patients, including more than 100 autopsies, a proposed framework for optimized treatment options for treating COVID-19 patients in severe and critical condition, and a short discussion regarding Allocetra™ by Enlivex as a product candidate for consideration. Dr. Cordon-Cardo with be available to answer questions following the formal presentations.

Enlivex's management team will discuss the recently reported positive top-line results of a Phase Ib investigator-initiated clinical trial of Allocetra™ in five COVID-19 patients in severe and critical condition, and the on-going Phase II investigator-initiated clinical trial, which is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition. The clinical trial has been designed to assess Allocetra™ in combination with standard of care treatment, and plans to evaluate safety, tolerability, cytokine profile and efficacy parameters.

To register for the webinar, please click here.

Enlivex recently reported positive top-line results of a previously announced Phase Ib investigator-initiated clinical trial of Allocetra^TM in COVID-19 patients in severe and critical condition in Hadassah Hospital, one of the largest hospitals in Israel. The Phase Ib clinical trial included five COVID-19 patients, three in severe condition and two in critical condition. All five patients completely recovered from their respective severe/critical condition and were released from the hospital after an average of 5 days (severe) and 9 days (critical), following administration of Allocetra^TM, at which time they were all COVID-19 PCR negative. There were no reported severe adverse events relating to the administration of Allocetra^TM in the patients, and the therapy was well-tolerated.

ABOUT THE ALLOCETRA COVID-19 PHASE II CLINICAL TRIAL
The COVID-19 study is a multi-center investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition, as defined by the U.S. National Institute of Health (NIH), and is designed to assess Allocetra^TM in combination with standard of care treatment. Safety, tolerability, cytokine profile and efficacy parameters are planned to be evaluated. Up to twenty-four patients are expected to be recruited, subject to each patient’s eligibility and signing of an informed consent to participate and receive treatment. Eligibility criteria include an existing illness with at least one of (a) radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or (b) Sp/O2 ratio lower or equal to 94% on room air, or (c) requiring supplemental oxygen (low flow or high flow), with a P/F ratio of below 350 but higher than 150. Exclusion criteria include (a) pregnancy, lactation and childbearing potential woman who are not willing to use acceptable contraceptives measures for the entire study duration, (b) Illness combined with other organ failure requiring organ support other than a respirator, including Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30), (c) intubated patients (due to inability to sign an informed consent), (d) patients with malignant tumor, other serious systemic diseases and psychosis, (e) patients who are participating in other clinical trials or treated with any experimental agents that may contradict this trial, (f) co-infection of HIV or tuberculosis, (g) known immunocompromised state or medications known to be immunosuppressive, and (h) patients with P/F ratio or S/F ratio of <150 or a change in status of eligibility manifested by a rapid decline of  P/F ratio between eligibility status and actual drug delivery.

ABOUT ENLIVEX
Enlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve hyper-expression of cytokines (Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs) such as sepsis and COVID-19, as well as enhancement of immune activity against solid tumors in combination with CAR-T or immune checkpoint therapies.

For more information, visit http://www.enlivex.com.

Safe Harbor Statement:  This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA^TM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA^TM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties.  In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission.  The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

ENLIVEX CONTACT                                                                            
Shachar Shlosberger, CFO                                                                    
Enlivex Therapeutics, Ltd.                                                                      
shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACT
Eric Ribner
LifeSci Advisors
eric@lifesciadvisors.com

FAQ

What is the significance of the Enlivex webinar on November 5, 2020?

The webinar will discuss COVID-19 treatment findings, including results from over 68,000 patients and the potential of Allocetra™.

What were the results of the Phase Ib trial for Allocetra™ by Enlivex?

In the Phase Ib trial, all five COVID-19 patients treated with Allocetra™ recovered and were released from the hospital.

How many patients are involved in the ongoing Phase II clinical trial by Enlivex?

The Phase II trial plans to recruit up to twenty-four patients in severe or critical condition.

Who is presenting in the Enlivex webinar?

Dr. Carlos Cordon-Cardo from Mount Sinai hospital will present findings related to COVID-19 treatment options.