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Enlivex Therapeutics Ltd - ENLV STOCK NEWS

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

Overview of Enlivex Therapeutics Ltd

Enlivex Therapeutics Ltd (ENLV) is an Israel-based, clinical-stage biopharmaceutical company specializing in the field of immunotherapy. The company focuses on developing an allogeneic, off-the-shelf cell therapy designed to rebalance dysregulated immune responses by reprogramming macrophages to a homeostatic state. This innovative approach is applied across several therapeutic areas including severe inflammatory conditions, osteoarthritis, and various autoimmune and infectious diseases. Early clinical investigations target severe sepsis, complications in hematopoietic stem cell transplants, and inflammatory joint diseases such as psoriatic arthritis and knee osteoarthritis.

Clinical Development and Mechanism of Action

At the heart of Enlivex's research is Allocetra, a cell therapy candidate developed to reset abnormal, non-homeostatic macrophages. Unlike traditional treatments, Allocetra utilizes the body’s own natural regulatory mechanisms to modulate immune responses. This strategy not only addresses immediate clinical symptoms but also tackles the underlying pathophysiological processes of immune dysregulation. The company has successfully initiated multiple investigator-sponsored trials and randomized controlled studies to assess the therapy’s safety profile and potential clinical benefits. Ongoing research in conditions such as osteoarthritis and psoriatic arthritis highlights the broad potential of Allocetra to offer transformative treatment alternatives where existing therapies have limited efficacy.

Position in the Immunotherapy Landscape

Enlivex Therapeutics operates in a highly competitive and innovative segment of the life sciences industry. By focusing on macrophage reprogramming, the company distinguishes itself from other immunotherapy and cell therapy firms. Its strategy of using allogeneic cells enables off-the-shelf availability, thereby potentially reducing production complexities and shortening time-to-treatment. This unique value proposition underlines its relevance in contemporary immunotherapeutic paradigms while also addressing significant unmet medical needs in various clinical settings.

Key Business Areas and Research Focus

  • Macrophage Reprogramming: Employing its proprietary cell therapy to reset dysregulated immune cells.
  • Clinical Trials: Advancing early-phase trials in conditions like severe sepsis, graft versus host disease, and inflammatory joint diseases, which serve as proof-of-concept studies for the therapy’s mechanism of action.
  • Innovative Cell Therapy: Developing universal, off-the-shelf treatments with the potential to overcome limitations associated with autologous cell therapies.
  • Market Differentiation: Focusing on rare and difficult-to-treat conditions where conventional therapies have shown limited success.

Scientific Rationale and Industry Terminology

The scientific framework behind Enlivex's approach revolves around concepts such as immune homeostasis and macrophage plasticity. By targeting the inflammatory cascade and enabling macrophages to revert to their native, balanced state, Allocetra is posited as a potentially transformative intervention in areas where an exaggerated immune response leads to tissue damage and systemic complications. The rigorous clinical assessments being conducted are designed to quantify endpoints like pain reduction, improved joint function, and overall patient well-being using established indices and statistical methodologies.

Competitive Landscape and Investment Considerations

Within the biopharmaceutical industry, Enlivex stands out by focusing on a mechanism of action that taps into the regulatory potential of the immune system, thereby offering a counterpoint to therapies that rely solely on immunosuppression. This strategy positions the company in a unique niche that blends the principles of cellular therapy with precision immunomodulation. Investors and industry analysts typically examine parameters such as the safety profile observed in early-stage trials, the scalability of the off-the-shelf approach, and the breadth of the potential market for inflammatory and autoimmune indications. The transparent and phased clinical development strategy underscores the company’s commitment to rigorous scientific validation and adherence to regulatory standards.

Conclusion

Enlivex Therapeutics Ltd is a focused and innovative clinical-stage company working to bridge key gaps in the treatment of complex immune-mediated conditions. By emphasizing a cell therapy that rebalances the immune system through macrophage reprogramming, the company continues to build a robust clinical pipeline aimed at addressing some of the most challenging therapeutic areas in modern medicine. With its clear scientific rationale, structured developmental approach, and commitment to high-quality clinical research, Enlivex remains a noteworthy subject for in-depth investment research and clinical analysis.

Rhea-AI Summary
Enlivex Therapeutics Ltd. (ENLV) is developing AllocetraTM, a cell therapy for sepsis treatment. The phase 2 trial of AllocetraTM has enrolled all 120 patients and is expected to release data by Q1 2024.
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Enlivex Therapeutics Ltd. (ENLV) has received a new patent, US 11,883,429, from the U.S. Patent and Trademark Office for its immunotherapy product candidate, AllocetraTM. The patent provides additional intellectual property protection for the product's composition and manufacturing method in the United States.
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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the authorization from the Israeli Ministry of Health for a multi-country Phase I/II trial to evaluate the efficacy, safety, and tolerability of Allocetra™ injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients. The trial will consist of a safety run-in, open-label dose escalation phase, followed by a double-blind, randomized, placebo-controlled stage. The primary measurements will assess joint-pain and joint-function compared to placebo at three months, six months, and 12 months.
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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) completes enrollment in Phase II trial for Allocetra™ in patients with sepsis. Topline data expected in late Q1 2024.
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Enlivex focuses on inflammatory and autoimmune indications, initiates clinical program in osteoarthritis, and plans to seek external collaborations for oncology assets. Workforce reduction of approximately 50% expected.
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Enlivex Therapeutics to present corporate update at H.C. Wainwright 25th Annual Global Investment Conference
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Enlivex Therapeutics has announced that the first patient has been dosed under the amended protocol for the Company’s Phase II trial evaluating Allocetra™ in patients with sepsis. The amended protocol allows a higher SOFA score inclusion range, allowing the recruitment of patients with higher levels of sepsis severity. The protocol also provides for two cohorts (treatment and placebo) instead of four, streamlining the trial. The company expects the top-line data readout from the Phase II trial to be in Q1 2024, consistent with their previously announced timeline.
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Enlivex Therapeutics Ltd. (Nasdaq: ENLV) will present a corporate update at the 2023 Jefferies Healthcare Conference on June 9, 2022, at 11:30 AM Eastern Time. The webcast of the presentation will be available at https://wsw.com/webcast/jeff281/enlv/1860430.
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FAQ

What is the current stock price of Enlivex Therapeutics (ENLV)?

The current stock price of Enlivex Therapeutics (ENLV) is $0.95 as of April 1, 2025.

What is the market cap of Enlivex Therapeutics (ENLV)?

The market cap of Enlivex Therapeutics (ENLV) is approximately 20.7M.

What is the core focus of Enlivex Therapeutics Ltd?

Enlivex Therapeutics Ltd is focused on developing an allogeneic cell therapy aimed at rebalancing immune responses through macrophage reprogramming, addressing conditions such as severe sepsis and inflammatory joint diseases.

How does Allocetra work as a therapeutic option?

Allocetra works by reprogramming non-homeostatic macrophages into their natural, balanced state, thereby helping to modulate the immune system and potentially reduce damaging inflammatory responses.

In which therapeutic areas is Enlivex conducting clinical trials?

Enlivex is investigating Allocetra in various clinical settings including severe sepsis, conditions associated with graft versus host disease, osteoarthritis, and psoriatic arthritis, among other inflammatory conditions.

What differentiates Enlivex from other companies in the immunotherapy space?

Enlivex differentiates itself by focusing on a unique mechanism of action through macrophage reprogramming, which offers a novel and off-the-shelf solution compared to traditional immunosuppressive or autologous cell therapies.

Why is immune rebalancing important in treating inflammatory diseases?

Immune rebalancing is crucial because it targets the underlying dysregulation in the immune system, potentially mitigating tissue damage and systemic complications that occur when the body’s natural response becomes excessive or misdirected.

What are the advantages of an off-the-shelf cell therapy product like Allocetra?

An off-the-shelf cell therapy can be made readily available, reducing the complexity and waiting times associated with autologous therapies. This approach also has the potential for scalable manufacturing and consistent quality control.

How does the company ensure the safety and efficacy of its therapy?

The safety and efficacy of Allocetra are evaluated through multiple phases of clinical trials, including rigorous safety run-ins and randomized, placebo-controlled studies that measure endpoints such as pain reduction and functional improvement.

What kind of investor or research interest does Enlivex attract?

Enlivex attracts interest from investors and analysts focused on innovative biopharmaceuticals, particularly those looking at next-generation cell therapies and immunomodulatory treatments that address significant unmet medical needs.
Enlivex Therapeutics Ltd

Nasdaq:ENLV

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ENLV Stock Data

20.74M
19.34M
5.59%
22.15%
0.52%
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