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Enlivex Therapeutics Ltd. (NASDAQ: ENLV) is an Israel-based clinical-stage immunotherapy company focused on developing innovative allogeneic drugs to rebalance the immune system. The company's flagship product candidate, Allocetra™, is under development for multiple severe and critical conditions.
Allocetra™ is currently in a Phase IIB clinical trial targeting patients with severe sepsis, a life-threatening condition caused by the body's response to infection. Additionally, it is being investigated in a Phase II clinical trial for the treatment of COVID-19 patients with severe and critical conditions. The company is also exploring Allocetra™ in a Phase IIA trial for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplants (HSCT).
Enlivex is advancing Allocetra™ as a potential treatment for complications associated with bone marrow transplants, acute multiple organ failure, and as a combination therapy with various anti-cancer treatments to enhance efficacy. The immunotherapy works by reprogramming macrophages to their homeostatic state, thus rebalancing the immune system.
Recently, the Israeli Ministry of Health authorized a new trial for Allocetra™ targeting osteoarthritis, a chronic inflammatory condition affecting millions worldwide. This multi-country, double-blind, placebo-controlled Phase I/II trial aims to evaluate the safety and efficacy of Allocetra™ injections in knee osteoarthritis patients.
The company has shown promising results in its Phase II study of Allocetra™ in sepsis patients, demonstrating a favorable safety profile and potential effectiveness. With approvals from the Danish Medicines Agency and other international regulators, Enlivex is extending its clinical trials across multiple countries to further evaluate Allocetra™'s broad therapeutic potential.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced participation in the Allogeneic Cell Therapies Summit 2022 and the 20th Biomed Israel Conference. Presentations include topics on their innovative therapy, Allocetra™, targeting solid tumors and cytokine storms linked to sepsis and COVID-19. Key details include a presentation on 'Next Generation Allogeneic Modality for Solid Tumors' on May 10, 2022, and two presentations at the Biomed Israel Conference on May 10 and 12. The focus is on the therapeutic potential of Allocetra™ in treating severe conditions.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced promising preclinical results for its cell therapy Allocetra™ combined with immune checkpoint inhibitors in treating mesothelioma. A study revealed up to 100% survival in mice receiving the combination treatment versus 0% survival in untreated mice. Allocetra™ alone achieved a 28.5% survival rate. This positions Allocetra™ as a potential innovative therapy for difficult-to-treat solid tumors, prompting plans for clinical trials in 2022 to evaluate its efficacy in patients with advanced-stage cancers.
Enlivex Therapeutics Ltd. announced the issuance of U.S. Patent Nos. 11,304,976 and 11,318,163, securing intellectual property protection for treating sepsis with Allocetra™ until at least 2036. CEO Oren Hershkovitz emphasized that these patents strengthen their sepsis program, particularly for pneumonia, urinary, and biliary infections. The company is advancing its Phase II trial of Allocetra™, designed to reprogram macrophages and address life-threatening conditions. Enlivex aims to expand its patent portfolio globally.
Enlivex Therapeutics (Nasdaq: ENLV) announced the acceptance of an abstract for a poster presentation at the 2022 ASCO Annual Meeting, scheduled for June 3-7, 2022, at the McCormick Place in Chicago.
The poster, titled "In-vivo reprogramming macrophages and dendritic cells with Allocetra-OTS", covers successful antitumor therapy. The presentation will take place on June 5, 2022, between 8:00 AM and 11:00 AM CDT.
Allocetra™ aims to restore macrophage homeostasis, presenting a potential new immunotherapeutic approach for treating various diseases.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the completion of the frozen formulation of Allocetra™ in Q1 2022, twelve months ahead of schedule. This reformulation enhances shelf-life and manufacturing scalability, potentially lowering costs and increasing profitability. The company will integrate the frozen formulation into its ongoing Phase II sepsis trial, slightly delaying the trial's completion by 6-8 months but expediting eventual regulatory approval. Enlivex is deprioritizing its COVID-19 program to focus on sepsis and oncology, extending its cash runway to Q3 2024.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the issuance of Israeli Patent Number 255119 for 'Therapeutic Pooled Blood Apoptotic Cell Preparations.' This patent grants intellectual property protection in Israel until at least 2037, covering the use of pooled donor cells in their Allocetra product. CEO Oren Hershkovitz emphasized the importance of a strong patent portfolio in their corporate strategy. Enlivex is developing Allocetra as an off-the-shelf cell therapy aimed at reprogramming macrophages to treat severe diseases, addressing critical unmet medical needs.
Enlivex Therapeutics has appointed Dr. Einat Galamidi as Vice President, Medical. Dr. Galamidi brings a decade of clinical development experience from Gamida Cell, where she led the development of omidubicel, a cell therapy for blood cancers. This therapy has recently initiated a Biologics License Application process with the FDA. Dr. Galamidi aims to leverage her expertise in advancing Enlivex's Allocetra program, which targets sepsis and COVID-19, among other conditions, to restore macrophage homeostasis and address unmet medical needs.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced participation in the 11th Annual LifeSci Partners Corporate Access Event from January 5-7, 2022. Management will engage in a panel discussion titled "Innovative Approaches to Cell Therapy for Oncology" on January 7 at 8:30 AM ET. The event aims to highlight innovative biotechnology and therapeutic advancements, focusing on unmet medical needs in oncology. Enlivex is advancing Allocetra™, a universal cell therapy designed to reprogram macrophages, targeting serious conditions like solid cancers and sepsis, aiming to restore immune balance.
Enlivex Therapeutics Ltd. announced that Greece’s National Organization of Medicines has approved the expansion of its Phase IIb trial for AllocetraTM in severe COVID-19 patients to additional sites. The trial aims to enroll up to 152 patients and assess the drug's safety and efficacy alongside standard treatment. Previously reported trials indicated a 0% mortality rate and a 90.5% recovery rate in severe cases. Top-line data is anticipated in late 2022 or Q1 2023. The company aims to expand its clinical trials throughout Europe.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its Phase II trial for AllocetraTM in pneumonia-associated sepsis has received approval for expansion into Greece. The trial, already active in Israel and Spain, aims to enroll 120 to 160 patients across four cohorts, assessing safety and efficacy over a 28-day follow-up. Previous Phase Ib results indicated a positive safety profile and improved clinical outcomes. Interim results are expected in the first half of 2022, with top-line data anticipated by year-end 2022.
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