Enlivex Granted Japanese Patent for Allocetra™ in Osteoarthritis Treatment

Nes-Ziona, Israel, October 30, 2024 – Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has announced that the Japanese Patent Office has issued a notice of allowance for their patent application numbered 2022-512861. This application, titled "Therapeutic Apoptotic Cells for Treatment of Osteoarthritis," is a significant development for the company, promising extended intellectual property rights through at least 2040. Enlivex anticipates that this patent will be formally issued in Japan by the end of the second quarter of 2025.

Dr. Oren Hershkovitz, CEO of Enlivex, highlighted the importance of this milestone, noting that it underscores the company's dedication to safeguarding the commercial potential of Allocetra™ in major global markets. Dr. Hershkovitz expressed confidence that this achievement reflects the successful implementation of their global intellectual property strategy. Moving forward, Enlivex aims to secure multiple layers of patent protection in essential markets worldwide as they advance the development of Allocetra™ as a pioneering cell therapy for osteoarthritis. Osteoarthritis currently presents a significant unmet medical need with limited effective treatment options.

Osteoarthritis, particularly knee osteoarthritis, is the most prevalent form of arthritis, affecting over 32.5 million Americans and more than 300 million people globally. Incidences of osteoarthritis are expected to rise, with projections suggesting that 78 million Americans will suffer from the condition by 2040. This disease is notably common and disabling, with 40% of men and 47% of women likely to develop knee osteoarthritis during their lifetimes. The condition accounts for over a million hospitalizations annually in the United States, primarily due to total joint replacements. The immense burden of osteoarthritis highlights the urgent need for treatments that can alleviate pain and minimize disability. Currently, there are no FDA or EMA-approved medications that have been proven to halt, slow, or reverse the structural damage associated with osteoarthritis in joints.

Enlivex Therapeutics is at the forefront of developing Allocetra™, an innovative, off-the-shelf cell therapy designed to reprogram macrophages to their homeostatic state. Restoring non-homeostatic macrophages to their homeostatic condition is crucial for rebalancing the immune system and resolving life-threatening conditions. Enlivex’s mission is to advance this promising therapy, which holds the potential to address various medical needs.

Enlivex’s dedication to progressing Allocetra™ is evident in their continuous efforts to secure robust intellectual property protections and advance their clinical programs. By establishing strong patents in key markets, the company aims to ensure the commercial viability of their innovative therapies. This strategic approach is critical as they work towards developing effective treatments for conditions like osteoarthritis, which have historically had limited therapeutic options.

The issuance of the patent notice by the Japanese Patent Office is a promising step forward for Enlivex. It not only strengthens their intellectual property portfolio but also reinforces their commitment to bringing new, effective treatments to market. The company’s proactive stance in securing patents globally reflects their strategic foresight and dedication to addressing significant healthcare challenges. As they continue to advance Allocetra™ and other therapies, Enlivex remains focused on their goal of improving patient outcomes through innovative medical solutions.