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Enlivex Therapeutics Ltd. Ordinary Shares - ENLV STOCK NEWS

Welcome to our dedicated page for Enlivex Therapeutics Ltd. Ordinary Shares news (Ticker: ENLV), a resource for investors and traders seeking the latest updates and insights on Enlivex Therapeutics Ltd. Ordinary Shares stock.

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.

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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has initiated a Phase I/II clinical trial for Allocetra™, targeting advanced solid tumor patients. This multi-center trial aims to assess the safety, tolerability, and preliminary efficacy of Allocetra™ as both monotherapy and in combination with the PD1 checkpoint inhibitor. The trial builds on promising preclinical results that indicated significant survival benefits in murine models. The trial will enroll up to 48 patients, evaluating different dosing strategies to monitor impacts on overall survival and immune profiling.

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Enlivex Therapeutics (Nasdaq: ENLV) announced a poster presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer from November 8-12, 2022, in Boston. The presentation titled “Synergistic anti-tumor effect of Allocetra–OTS, a cellular immune-therapy” is scheduled for November 10 and 11. Enlivex focuses on immunotherapy with its product Allocetra™, designed to reprogram macrophages to enhance immune response against cancer. For conference registration, visit the provided link.

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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its participation at the 4th Macrophage-directed Therapies Summit in Boston from October 4-6, 2022. The company's presentation is scheduled for October 6 at 2:30 PM ET, where management will discuss clinical programs targeting sepsis and solid cancers, along with supporting data. The summit will cover strategies to enhance macrophage therapies and facilitate discussions on clinical applications. Interested parties can register for the event here.

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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its participation in multiple investor conferences in September 2022. The company will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 11:00 AM ET, and at Baird’s 2022 Global Healthcare Conference on September 14, 2022, at 3:10 PM ET. Additionally, Enlivex will engage in a panel discussion at the Cantor Cell and Genetic Medicines Conference on September 15, 2022, at 9:20 AM ET. Management will also be available for one-on-one meetings during these events.

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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced significant preclinical data at the ESMO Congress 2022, demonstrating that the combination of Allocetra™ with cisplatin resulted in a 55% survival rate in a murine mesothelioma model, compared to 0% in untreated and cisplatin monotherapy groups. These results support the ongoing Phase I/II trial of Allocetra™ combined with chemotherapy for patients with peritoneal metastases from solid tumors. Allocetra™ aims to reprogram macrophages to enhance anti-cancer responses.

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Enlivex Therapeutics (Nasdaq: ENLV) announced on Sept. 6, 2022, that it received a Notice of Allowance from the U.S. Patent and Trademark Office for patent application 15/551,284. This patent will enhance the company's intellectual property protection for Allocetra™, extending through at least 2036. Allocetra™ is aimed at inhibiting cytokine release syndrome in CAR T-cell therapy patients. The patent is expected to be granted by Q1 2023. CEO Oren Hershkovitz emphasized the significance of this patent in broadening Enlivex's valuable IP portfolio.

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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the issuance of a Notice of Allowance from the Japanese Patent Office for patent application number 2020-198242. This patent will grant intellectual property protection for the use of pooled donor cells in Allocetra™, extending protection until at least 2037. Enlivex aims to bolster its global IP strategy to enhance the commercial potential of Allocetra™, a reprogramming immunotherapy targeting diseases like sepsis and solid tumors. The patent is expected to be issued in Q2 2023, emphasizing Enlivex’s commitment to addressing unmet medical needs.

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Enlivex Therapeutics has received regulatory clearance for amendments to its Phase II sepsis trial protocol in Israel, Spain, and Greece. The amendments introduce a frozen Allocetra™ formulation, improving shelf life and scalability, potentially lowering costs. The trial will now include patients with septic conditions beyond pneumonia, addressing a significant medical need, given that sepsis affects 1.7 million adults annually in the U.S. The company anticipates these changes may accelerate regulatory approval and commercialization timelines.

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Enlivex Therapeutics announced significant advancements in its oncology and sepsis programs, highlighted by the dosing of the first patient in a Phase I/II trial assessing Allocetra™ with chemotherapy for patients with peritoneal metastases. The Israeli Ministry of Health approved a separate trial for Allocetra™ combined with a PD1 inhibitor. Preclinical studies indicate strong survival benefits in ovarian cancer and mesothelioma using Allocetra™. The company appointed Dr. Roger J. Pomerantz as Vice Chairman and maintains a solid financial position, with $62.5 million in cash as of June 30, 2022.

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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the Israeli Ministry of Health has approved a Phase I/II clinical trial for Allocetra™, aimed at patients with advanced solid tumors. This trial follows positive preclinical studies with Yale Cancer Center indicating significant survival benefits when Allocetra™ was combined with PD1 checkpoint inhibition. The trial will enroll up to 48 patients, evaluating safety, tolerability, and preliminary efficacy of Allocetra™ alone and combined with anti-PD1 therapy. The study addresses a significant unmet medical need in cancer treatment.

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FAQ

What is the current stock price of Enlivex Therapeutics Ltd. Ordinary Shares (ENLV)?

The current stock price of Enlivex Therapeutics Ltd. Ordinary Shares (ENLV) is $1.24 as of December 20, 2024.

What is the market cap of Enlivex Therapeutics Ltd. Ordinary Shares (ENLV)?

The market cap of Enlivex Therapeutics Ltd. Ordinary Shares (ENLV) is approximately 25.8M.

What is Enlivex Therapeutics Ltd.?

Enlivex Therapeutics Ltd. is an Israel-based clinical-stage immunotherapy company developing allogeneic drugs to rebalance the immune system.

What is Allocetra™?

Allocetra™ is Enlivex's flagship immunotherapy candidate, designed to reprogram macrophages and rebalance the immune system. It is being tested for severe sepsis, COVID-19, GVHD, and more.

What clinical trials are ongoing for Allocetra™?

Allocetra™ is in Phase IIB trials for severe sepsis, Phase II for COVID-19, and Phase IIA for GVHD prevention. Additionally, it's being tested in a Phase I/II trial for knee osteoarthritis.

What recent achievements has Enlivex made?

Enlivex received approval from the Israeli Ministry of Health for a new osteoarthritis trial and announced positive Phase II study results for Allocetra™ in sepsis patients.

What is the significance of Allocetra™ in osteoarthritis treatment?

Allocetra™ is being evaluated for its potential to reprogram macrophages and address the inflammatory causes of osteoarthritis, offering a novel treatment option.

How does Allocetra™ work?

Allocetra™ works by restoring macrophages to their homeostatic state, helping to rebalance the immune system and treat various severe and chronic conditions.

What are the benefits of Enlivex's therapy?

Enlivex's Allocetra™ offers a potential new mechanism of action for treating life-threatening and debilitating conditions by modulating the immune system.

What is the company's financial condition?

Enlivex recently closed a $5 million registered direct offering, indicating strong financial support for its ongoing and future clinical trials.

What are the future plans for Allocetra™?

Enlivex plans to continue expanding its clinical trials for Allocetra™, including potential larger studies for sepsis and ongoing trials for knee osteoarthritis.

Where can I find more information about Enlivex?

For more details, visit Enlivex's official website at http://www.enlivex.com.

Enlivex Therapeutics Ltd. Ordinary Shares

Nasdaq:ENLV

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25.77M
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