Enlivex Receives Notice of Allowance for US Patent Application Covering the Treatment of Sepsis Patients With Allocetra
Enlivex Therapeutics Ltd. recently announced the US Patent and Trademark Office issued a notice of allowance for a new patent application (number 16/194,417) covering Allocetra, the company’s immunotherapy product candidate. Upon issuance, the patent will provide added intellectual property protection in the US at least through 2036 with claims covering the use of Allocetra for treating sepsis patients. The company expects that this new patent will be issued in the US in early 2022.
Enlivex is currently evaluating Allocetra in a placebo-controlled, randomized, dose-finding, multi-center, Phase 2 trial in patients with pneumonia-associated sepsis. The trial, which has multiple sites currently open for enrollment in Israel and has been cleared to expand into Spain, is expected to enroll 120 to 160 patients across 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. The trial is supported by previously reported positive results from a Phase 1b trial that demonstrated a positive safety profile and vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in Allocetra-treated sepsis patients compared to a group of matched historical controls that received standard-of-care therapy. Interim results from the trial are expected in the first half of 2022, and top-line data are expected by year-end 2022.
In addition to sepsis, Enlivex also has development programs targeting severe and critical COVID-19 infections and solid tumors.
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, 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 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.
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