Enlivex Announces Issuance of New U.S. Patent Covering Allocetra Cells and Their Manufacturing Method

Rhea-AI Summary

Enlivex Therapeutics Ltd. (ENLV) has received a new patent, US 11,883,429, from the U.S. Patent and Trademark Office for its immunotherapy product candidate, AllocetraTM. The patent provides additional intellectual property protection for the product's composition and manufacturing method in the United States.

Positive

• Enlivex Therapeutics Ltd. (ENLV) has successfully obtained a new patent for its immunotherapy product candidate, adding to its intellectual property protection.

Negative

• None.

Biotechnology Patent Analyst

The issuance of US patent number 11,883,429 for Enlivex Therapeutics' AllocetraTM represents a significant enhancement of the company's intellectual property portfolio. The patent covers not only the composition of the immunotherapy product but also its manufacturing method, which can be crucial for biotech firms in maintaining a competitive edge. This dual aspect of protection is particularly important in the biotech industry, where the ability to produce a complex biological product reliably and at scale can be as valuable as the product itself.

For stakeholders, this patent can provide assurance of market exclusivity, potentially leading to a stronger negotiating position in partnership discussions or licensing deals. It's also likely to act as a deterrent against competitors considering the development of similar therapies. From an investment perspective, a robust patent estate is often viewed favorably, as it can mitigate the risk of generic competition and may extend the product's revenue-generating lifecycle beyond the initial regulatory exclusivity period.

Pharmaceutical Market Analyst

The strategic impact of the new patent for Enlivex's AllocetraTM on the market cannot be overstated. By securing additional intellectual property rights, Enlivex potentially extends its commercial runway and fortifies its market position. It's essential to evaluate the competitive landscape of macrophage reprogramming immunotherapies and consider the potential market size for AllocetraTM. If the therapy addresses a significant unmet medical need, the patent could be instrumental in capturing a substantial market share.

Investors should monitor the progression of clinical trials and regulatory milestones, as these will provide further indication of AllocetraTM's market potential. Positive clinical outcomes coupled with strong IP protection could significantly increase the company's valuation. However, it's important to remain cognizant of the inherent risks in drug development, such as trial failures or unforeseen safety issues, which could impact the company's prospects regardless of patent status.

Legal Expert in Biotech Intellectual Property

The granting of a new patent in the biotechnology sector is a nuanced affair with implications that extend beyond mere legal ownership. The scope of the patent, particularly in the context of composition and manufacturing methods, can reveal the breadth and depth of the protection afforded to Enlivex's AllocetraTM. A broad claim can hinder competitors from circumventing the patent without significant innovation, thereby reinforcing Enlivex's market position.

It is essential to scrutinize the claims of patent US 11,883,429 to understand their enforceability and potential challenges from competitors. The strength of a patent is not only in its grant but in its ability to withstand litigation. For investors, the robustness of Enlivex’s patent can be a litmus test for the company's future revenue potential and its ability to attract strategic partnerships or funding.

Nes-Ziona, Israel, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd., (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the U.S. Patent and Trademark Office issued a new patent, number US 11,883,429, covering Allocetra^TM, the Company’s immunotherapy product candidate. The new patent is expected to provide added intellectual property protection in the United States for the product’s composition and manufacturing method.

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

                                                

What is the ticker symbol for Enlivex Therapeutics Ltd.?

The ticker symbol for Enlivex Therapeutics Ltd. is ENLV.

What is the new patent number issued to Enlivex Therapeutics Ltd.?

The new patent number issued to Enlivex Therapeutics Ltd. is US 11,883,429.

What does the new patent cover for Enlivex Therapeutics Ltd.?

The new patent covers AllocetraTM, the Company’s immunotherapy product candidate, providing intellectual property protection for its composition and manufacturing method in the United States.