Enlivex Receives Notice of Allowance for U.S. Patent Application Covering Methods of Treating Sepsis with Allocetra™
Nes-Ziona, Israel, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for patent application number 16/594,463. Once issued, the resulting patent will provide Enlivex with added intellectual property (IP) protection into at least 2036 with additional claims covering methods of treating sepsis with Allocetra™, on top of previously granted patents. The Company expects that this new patent will be issued in the United States in the fourth quarter of 2022.
“Receiving this Notice of Allowance is an important corporate achievement that we believe positions us to optimize Allocetra’s™ commercial potential in sepsis,” said Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex. “The resulting patent will provide an additional layer of protection for this program, which targets a multi-billion-dollar market that is not well served by current therapies. In addition, we continue to work diligently to further expand our IP portfolio with patents covering Allocetra’s™ use in other indications.”
Enlivex’s sepsis program includes an ongoing placebo-controlled, randomized, dose-finding, multi-center Phase II trial, which includes four cohorts receiving varying doses of Allocetra™ or placebo, all in addition to standard-of-care therapy. The trial's two primary endpoints are safety (number and severity of adverse events and severe adverse events) and efficacy (change from baseline in sequential organ failure (SOFA) score), which will be assessed throughout a 28-day follow-up period. Additionally, the trial's secondary endpoint is 28-day all-cause mortality. Interim results from the trial are expected in the first quarter of 2023. Top-line data are expected in the third quarter of 2023.
Allocetra™ 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, 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™ 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.
Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, 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.
INVESTOR RELATIONS CONTACT