Enlivex Announces Issuance of New U.S. Patent Covering Methods of Treating Gout, Inflammatory Bowel Disease, Crohn’s Disease, Ulcerative Colitis and GvHD Using Allocetra Immunotherapy

Rhea-AI Summary

Enlivex Therapeutics announced the issuance of U.S. Patent No. 10,927,343 for Allocetra^TM, its macrophage reprogramming immunotherapy. This patent enhances intellectual property protection for treating autoimmune and inflammatory diseases, including Crohn's disease and ulcerative colitis. While focusing on critical diseases like sepsis and COVID-19, preclinical data suggest Allocetra^TM may provide immune rebalancing for unmet medical needs. This development aims to establish a novel therapy mechanism targeting life-threatening conditions.

Positive

• Issuance of U.S. Patent No. 10,927,343 enhances intellectual property protection for Allocetra^TM.
• Potential applications of Allocetra^TM extend to autoimmune conditions with no effective treatments.
• Positive preclinical data indicating Allocetra^TM's effectiveness in immune rebalancing.

Negative

• Focus primarily on life-threatening diseases means potential market limitations for autoimmune applications.
• The need for ongoing clinical trials and regulatory approvals poses risks to product development timelines.

Nes-Ziona, Israel, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd., (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,927,343 covering Allocetra^TM, the company’s immunotherapy product candidate.  The new patent is expected to provide added intellectual property protection for methods of treating autoimmune and inflammatory diseases comprising gout, inflammatory bowel disease, Crohn’s disease, ulcerative colitis and graft versus host disease (GvHD).

Oren Hershkovitz, PhD, CEO of Enlivex, stated, “We are pleased with this new patent allowance. While we are focusing our clinical development efforts at this stage on life-threatening diseases with high mortality rates and no effective treatments such as sepsis, COVID-19, and solid tumors, pre-clinical data demonstrate the potential applicability of Allocetra^TM in providing immune rebalancing for patients with autoimmune or inflammatory diseases with no effective treatment options today, such as Crohn’s Disease.”

Allocetra^TM is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra^TM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as “unmet medical needs”, as a stand-alone therapy or in combination with leading therapeutic agents. In preclinical models, positive effects of Allocetra^TM were observed in several autoimmune and inflammatory diseases.

ABOUT ENLIVEX

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra^TM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. 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 U.S. Patent No. 10,927,343 for ENLV?

This patent provides Enlivex with enhanced intellectual property protection for Allocetra^TM, essential for treating autoimmune and inflammatory diseases.

How does Allocetra^TM work?

Allocetra^TM reprograms macrophages into their homeostatic state, potentially improving outcomes in diseases like sepsis and COVID-19.

What diseases is Enlivex targeting with Allocetra^TM?

Enlivex is focusing on critical diseases including sepsis, COVID-19, and certain autoimmune conditions like Crohn's disease.

What are the risks associated with Enlivex's future product developments?

Risks include the potential for clinical trials to not yield expected results, impacting approval and market entry.

When was the patent for Allocetra^TM issued?

The U.S. Patent No. 10,927,343 was issued on February 16, 2021.